Why is Latin America considered a hotspot for clinical trials?

Latin America is recognized as a hotspot for clinical trials due to its diverse patient population, lower operational expenses in countries like Brazil, Mexico, and Argentina, and a developing regulatory framework that supports medical studies.

What challenges do Medtech companies face in Latin America?

Medtech companies encounter challenges such as regulatory hurdles, professionalism issues, language barriers, and fragmented resources, which can hinder effective communication and collaboration with American clinical research clients.

What factors contribute to Brazil's status as a clinical trial hotspot?

Brazil's robust healthcare infrastructure and diverse patient demographics facilitate the recruitment of varied patient populations, leading to significant research activity, particularly in Phase III studies.

How does Mexico support clinical trials?

Mexico has a favorable regulatory environment that promotes pharmaceutical research, resulting in a high number of studies involving human subjects and strong partnerships between patients and healthcare providers.

What role does Colombia play in the clinical trial landscape?

Colombia has emerged as a clinical trial hotspot due to supportive governmental policies, competitive costs, and a growing number of experiments being conducted, backed by effective partnerships with local CROs.

What is the significance of partnerships in conducting clinical trials in Latin America?

Successful partnerships between researchers and local healthcare providers are crucial for the success of medical studies in Latin America, as they enhance collaboration and facilitate recruitment.

What are some successful examples of clinical trials in Latin America?

Successful examples include the partnership between Greenlight Guru and bioaccess™, which expedited Medtech innovations, and Flow-FX's first-in-human study in Colombia, demonstrating effective strategies in clinical trials.

How does INVIMA contribute to clinical trials in Colombia?

INVIMA, Colombia's National Food and Drug Surveillance Institute, oversees research studies, ensuring adherence to national standards and facilitating the importation of investigational devices.

What is expected for the future of clinical trials in Latin America?

The clinical trial hotspots in Latin America are anticipated to experience significant growth, especially in Phase III studies, driven by the expansion of Contract Research Organizations (CROs) and improved patient-physician relationships.

Does ANVISA need to approve a Class III device study in Brazil?

Not always. ANVISA Protocol 2025289179 (December 9, 2025) confirmed that academic, non-commercialization clinical studies with medical devices — including Class III and Class IV devices — do not require prior ANVISA regulatory review under RDC 837/2023. These studies require only Ethics Committee (CEP/CONEP) approval. The exemption is conditioned on the study's purpose: the protocol must explicitly state no intent to pursue Brazilian ANVISA registration.

What is ANVISA Protocol 2025289179?

ANVISA Protocol 2025289179 is a written regulatory clarification issued on December 9, 2025, by ANVISA's General Office of Technology Products for Health (GGTPS — Gerência Geral de Tecnologia de Produtos para a Saúde), signed by ANVISA officer Rafaela de Lima Avelino. It confirmed that strictly academic, non-commercialization clinical investigations with medical devices can proceed in Brazil under Ethics Committee (CEP/CONEP) approval alone, without a prior ANVISA regulatory review, regardless of device risk class. It is one of four primary sources — along with RDC 837/2023, Lei 14.874/2024, and Decreto 12.651/2025 — that together define this regulatory pathway.

How quickly can a CEP-only device study get approved in Brazil?

CEP/CONEP review timelines vary by site and by the complexity of the submission. Academic device studies that meet the non-commercialization criteria and are submitted to experienced ethics committees at leading Brazilian academic medical centers have generally been reviewed on a faster timeline than full ANVISA regulatory submissions. Lei 14.874/2024 introduced a 90-business-day ANVISA review limit for full submissions; for CEP-only studies, the critical path is defined by the ethics committee, site contracting, and device importation authorization, not by ANVISA. bioaccess® manages all three workstreams in parallel to minimize total activation time.

Does the ANVISA importation authorization still apply to CEP-only device studies?

Yes. Obtaining CEP/CONEP approval under the academic, non-commercialization pathway does not exempt the sponsor from ANVISA importation clearance requirement under RDC 172/2017 for the unregistered investigational device. Importation authorization is a separate ANVISA administrative process, distinct from pre-study regulatory review of the clinical investigation itself. It must be completed before the device can enter Brazil for use in the study. Sponsors should plan for importation authorization as a parallel workstream during site activation.

When should a sponsor get a Brazilian legal opinion on the CEP-only pathway?

Before contracting for study execution — particularly if the study is commercially sponsored rather than academic-institution-led, or if the sponsor has any possibility of later pursuing Brazilian ANVISA registration using data generated under the CEP-only pathway. Both scenarios involve regulatory nuances not fully resolved by RDC 837/2023 or Protocol 2025289179 alone. A formal written legal opinion from qualified Brazilian regulatory counsel, obtained before study activation, is the appropriate way to manage those risks.

Can a commercially funded study qualify for the CEP-only pathway under RDC 837/2023?

The source of funding — sponsor-funded versus investigator-initiated grant-funded — is not the dispositive factor. The operative criteria under RDC 837/2023, Lei 14.874/2024, and Decreto 12.651/2025 are the study's purpose (academic or scientific) and the absence of commercialization intent in Brazil. However, a commercially-structured EFS where the sponsor has meaningful involvement in study design, execution oversight, and data ownership introduces questions about whether the study meets the academic characterization. This distinction warrants Brazilian legal counsel review before the protocol is finalized.

Author: Julio Martinez-Clark

Five Questions Every Medtech Founder Must Ask A CRO Before Signing The MSA

Five Questions Every MedTech Founder Must Ask a CRO Before Signing the MSA

Published by bioaccess®^® | May 2026

The Most Expensive Vendor Decision You Will Make Before Your Series B

The master services agreement you sign with a CRO at the first-in-human stage is not just a vendor contract. It is a commitment to a timeline, a data architecture, a regulatory strategy, and — in ways most founders do not fully price until they are inside the engagement — a bet on whether that organization has ever actually done this before.

Most MedTech founders spend more time negotiating SaaS subscription pricing than interrogating the operational fitness of the CRO they are about to trust with their first human study. CROs are practiced at presenting capability decks that are both technically accurate and structurally misleading: yes, they have run first-in-human studies. The questions are how many, how recently, where, and with what kind of dedicated team.

Getting this wrong is costly in ways that do not appear on the MSA. A generalist CRO that applies Phase 3 operational logic to a 10-patient FIH study produces delays and data packages that do not travel well to FDA. The five questions below are designed for use in an actual vendor conversation, written so that an organization built specifically for first-in-human work answers all five without hesitation and a generalist CRO with Phase 3 heritage struggles on at least three. The contrast is the diagnostic.

Question 1: “What percentage of your active studies are first-in-human?”

This question cuts through every capability deck. Most large CROs list “Phase 1-4” as an integrated capability — and that is technically accurate. ICON, Syneos Health, and Parexel all offer first-in-human services. What their materials do not disclose is the proportion of revenue, headcount, and operational attention that FIH commands relative to their Phase 2-4 and post-market portfolio. According to the ICON plc 2024 Annual Report, the company’s growth narrative is anchored in Phase 2-4 and functional service offerings. Syneos Health’s service model is similarly configured around integrated biopharmaceutical solutions at scale — not the 10-patient device feasibility study a seed-stage founder needs to execute.

The operational implication: when FIH is a small fraction of a CRO’s active portfolio, the project managers on your study are people who primarily run Phase 3 logistics. They understand protocol compliance and site management at the multi-site scale. What they may not have is the judgment that comes from running dozens of first human exposures — the real-time risk calculus of dose escalation, the site selection nuances that matter when you have ten patients rather than three hundred, and the FDA communication posture that FIH-specific experience produces.

The follow-up question matters equally: “Who on your team has personally run more than ten first-in-human studies from device selection through first patient in?” An organization that cannot surface a dedicated FIH unit with named individuals and verifiable track records has not built FIH as an operational discipline.

Red flag: Any CRO that cannot give you a clean percentage of active studies that are first-in-human has not built FIH as an operational core. It is a line item in a service menu. A CRO for which FIH is the only practice answers this question with a number above 90 percent — because there is nothing else on the portfolio.

Question 2: “What is your documented median time from IND/IDE submission to site initiation in your primary jurisdiction?”

Timeline is not a soft preference. It is a capital efficiency variable. Every month between IND/IDE equivalent submission and first patient in is a month of runway consumed and a month of competitive exposure while your device sits in regulatory review.

The documented benchmark for ethics committee approval in Latin American FIH programs — for organizations with established site relationships and a mature submission infrastructure — is 4 to 8 weeks. In Colombia, where the regulatory framework has been shaped by over a decade of FIH execution, approval instances as fast as 15 to 18 days have been recorded. This is the result of site-level relationships, submission formatting that ethics committees recognize, and a regulatory team with institutional familiarity with the FIH protocol type.

The U.S. comparison is not subtle. The average IRB/EC cycle in the United States for a novel device IDE study runs 6 to 12 months from submission to site initiation when you account for FDA review, IRB submission, site contracting, and institutional compliance review. In the EU, a 6-month horizon from IDE equivalent to first patient in remains the conservative planning assumption most regulatory counsel will give you.

Illustrative Ethics Approval Timeline Comparison
Jurisdiction	Documented Range	Basis
LATAM (Colombia, established sites)	4-8 weeks (fastest: 15-18 days)	bioaccess® operational track record, 2010-present
United States (IDE pathway)	6-12 months (submission to site initiation)	FDA CDRH IDE review statistics
EU (CTR pathway)	3-9 months (submission to site initiation)	EMA Clinical Trials Regulation implementation data

When you ask this question, you are asking for documented median performance, not a best case. An organization that cannot answer with data has not been measuring what matters.

Question 3: “Have you produced a data package accepted by FDA from a non-U.S. trial in the past 36 months?”

The most persistent misconception among U.S. device founders about outside the United States clinical data is that FDA will not accept it. This misconception is expensive, because it leads founders to dismiss LATAM and other OUS execution pathways as regulatory dead ends when the regulatory framework explicitly accommodates foreign clinical data.

21 CFR 312.120 permits FDA acceptance of foreign clinical data when the trial was conducted in accordance with Good Clinical Practice and under a protocol FDA would consider adequate and well-controlled. 21 CFR 812.28 extends parallel provisions to device studies, explicitly addressing acceptance of data from foreign investigations in support of IDE and PMA submissions.

A first-in-human study conducted in Colombia, Brazil, or Peru under a GCP-compliant protocol, with a data architecture designed to meet FDA standards, can generate the foundational data package that supports a U.S. IDE submission. The LATAM study is not a workaround. It is a legitimate regulatory pathway.

Executing it correctly requires a CRO that has actually done it. “We could produce FDA-compatible data” is not the same as “we have produced FDA-accepted data from an OUS trial in the past three years.” Ask for the latter. Ask for the regulatory outcomes. Ask whether the data traveled to FDA and what the response was.

A CRO that has never navigated 21 CFR 312.120 or 812.28 in practice — regardless of what their regulatory affairs team says in a capabilities presentation — is asking you to be their learning case at the stage where you cannot afford that tuition.

Question 4: “What is your per-patient cost range for a 10-to-15 patient FIH study in your primary jurisdiction?”

Per-patient cost for a FIH study is the single most compressed way to understand the financial architecture of a CRO engagement before you are inside one. Cost transparency at the proposal stage is not a courtesy — it is a due diligence requirement.

The documented range for per-patient costs in Latin American clinical trial sites runs from approximately $15,000 to $35,000 per patient for a first-in-human medical device study. The equivalent range in the United States and European Union runs from $40,000 to $75,000 per patient for comparable FIH work. That differential — roughly 59 percent lower cost per patient in LATAM — reflects the structural economics of clinical site operations in markets where investigator compensation, institutional overhead, and support cost structures differ materially from U.S. and EU norms.

On a 10-patient FIH study, the arithmetic is direct: U.S. execution at $40,000-$75,000 per patient produces a $400,000-$750,000 direct study cost. LATAM execution at $15,000-$35,000 per patient produces a $150,000-$350,000 direct study cost. The difference — $250,000 to $400,000 — is material capital at the seed or pre-Series A stage. It extends runway. It funds the follow-on safety cohort. It covers FDA pre-submission preparation. It is the difference between a founder who enters their Series A with FIH data and remaining runway, and one who spent it all to generate the same data in a U.S. site.

A CRO that deflects to “it depends on the protocol” without offering a range for a standard FIH configuration has either not run enough FIH studies to have a stable cost model, or does not want you comparing numbers before you have signed.

Question 5: “Can you execute an EFS submission and manage a concurrent OUS FIH study under a single operational team?”

The FDA’s Early Feasibility Study program is one of the most underutilized regulatory tools available to U.S. MedTech founders. According to the FDA Early Feasibility Study Program, the EFS pathway is designed for early-stage devices where clinical data is needed to inform device design — precisely the stage at which a FIH study occurs. The MDIC 10-Year EFS Journey analysis documented that approximately 70 percent of EFS submissions receive FDA response within 30 days — a timeline that makes concurrent OUS and U.S. enrollment operationally feasible within the same funding window.

The strategic logic of concurrent execution is about data architecture, not just speed. A LATAM FIH study generating safety and early efficacy signals in parallel with a U.S. EFS enrollment produces a richer, more FDA-defensible data package than either study would generate independently. The LATAM cohort contributes patient volume and diverse population data; the U.S. cohort generates data with direct site-level FDA familiarity. Together, they build an IDE submission or PMA dataset from a position of evidence rather than assumption.

Executing this dual-track strategy requires a CRO that can manage both pathways under a coherent operational structure — not two separate vendor relationships requiring a founder as the integration layer. The question diagnoses whether a CRO has built the capacity to hold both regulatory tracks in a single team, or is offering LATAM execution on one hand and a referral to a U.S. partner on the other.

The U.S. EFS pathway and a concurrent LATAM FIH study are not competing strategies. They are the same strategy, executed in parallel, by an organization that understands both regulatory environments as a single integrated operation.

How to Use This Checklist

These five questions are not adversarial. They are clarifying. A CRO that has built its operations around first-in-human work will not find them uncomfortable — they will find them efficient, because the answers surface quickly from an organization that lives in this space every day.

Use the questions in the initial capabilities conversation, before you have a proposal on the table and a timeline pressure that makes switching feel costly. The moment to evaluate operational fit is before you have signed anything, not after you are inside a study running six months behind the timeline the capabilities deck implied.

What percentage of your active studies are first-in-human?
What is your documented median time from IND/IDE equivalent submission to site initiation?
Have you produced a data package accepted by FDA from a non-U.S. trial in the past 36 months?
What is your per-patient cost range for a 10-to-15 patient FIH study?
Can you execute an EFS submission and manage a concurrent OUS FIH study under a single operational team?

If the answers satisfy all five questions, you are talking to a CRO that may be able to run your first human study competently. If they do not, you have learned something before the signature, not after.

Ready to Run the Evaluation?

bioaccess® works with MedTech founders at every stage of FIH preparation — from regulatory strategy through first patient in. If you want to talk through your specific program against these five criteria:

Sources

June 30, 2026

Select The Right Clinical Trial Site In Brazil: A Step-By-Step Guide

<h2 id="introduction">Introduction</h2>

<p>Choosing the right clinical trial site in Brazil is crucial for the success of your research initiatives. Navigating Brazil's evolving regulatory landscape can be daunting for sponsors. Understanding the nuances of site selection is essential for success. This guide will help you identify and evaluate potential sites while tackling the logistical and recruitment challenges you might face.</p>

<p>So, how can you make sure your choices meet regulatory standards and boost patient recruitment in this ever-changing market?</p>

<h2 id="understand-brazils-regulatory-framework-for-clinical-trials">Understand Brazil's Regulatory Framework for Clinical Trials</h2>

<p>Before selecting a clinical trial site in Brazil, it is essential to grasp the regulatory landscape set by ANVISA for success. Key components include:</p>

<ol>

<li><a href="https://bioaccessla.com/blog/10-essential-clinical-trial-coordinator-duties-for-research-success">Approval Process</a>: <a href="https://grandviewresearch.com/horizon/outlook/clinical-trials-market/brazil" rel="noopener noreferrer nofollow" target="_blank">Clinical research applications must be submitted to ANVISA</a>, which now has a strict limit of 90 business days for approval under the new regulations effective from January 1, 2025. It's vital to meticulously prepare all necessary documentation, such as the clinical study protocol and informed consent forms, in line with ANVISA's guidelines.</li>

<li><a href="https://bioaccessla.com/blog/10-capa-corrective-action-preventive-action-strategies-for-clinical-research">Compliance Requirements</a>: Studies must adhere to ICH-GCP (International Council for Harmonisation – Good Clinical Practice) standards, crucial for protecting the rights, safety, and well-being of participants. Following these standards is not just a regulatory necessity; it also boosts the credibility of the data collected.</li>

<li><a href="https://bioaccessla.com/blog/10-essential-features-of-clinical-trial-data-software-for-success">Ethics Committee Approval</a>: In addition to ANVISA, studies must receive endorsement from a local ethics committee (Comitê de Ética em Pesquisa – CEP). This process evaluates the ethical aspects of the study, ensuring participant safety and adherence to ethical standards.</li>

<li>Documentation: Thorough documentation is essential for the review processes of both ANVISA and the ethics committee. It includes preclinical data, study protocols, and investigator qualifications, which must be thoroughly prepared to facilitate a smooth approval process.</li>

<li>Regulatory Changes: Stay informed about <a href="https://grandviewresearch.com/horizon/outlook/clinical-trials-market/brazil" rel="noopener noreferrer nofollow" target="_blank">recent legislative changes, such as Law No. 14.874/2024</a>, which aims to streamline the approval process and reduce bureaucratic hurdles. Grasping these transformations can offer a strategic edge in location selection and study execution, enabling quicker commencement of research activities.</li>

</ol>

<p>By mastering these regulatory nuances, sponsors position themselves for a more efficient and effective research journey at a clinical trial site in Brazil.</p>

<p><img alt="This flowchart guides you through the essential steps for navigating the regulatory landscape for clinical trials in Brazil. Each box represents a key component of the process, and the arrows show how they connect and flow into one another." src="https://images.tely.ai/telyai/rtsjkopf-this-flowchart-guides-you-through-the-essential-steps-for-navigating-the-regulatory-landscape-for-clinical-trials-in-brazil-each-box-represents-a-key-component-of-the-process-and-the-arrows-show-how-they-connect-and-flow-into-one-another.webp" title="This flowchart guides you through the essential steps for navigating the regulatory landscape for clinical trials in Brazil. Each box represents a key component of the process, and the arrows show how they connect and flow into one another."/></p>

<h2 id="identify-and-evaluate-potential-clinical-trial-sites">Identify and Evaluate Potential Clinical Trial Sites</h2>

<p>Identifying the right <a href="https://bioaccessla.com/br">clinical trial site Brazil</a> is a complex challenge that requires a strategic approach to ensure successful outcomes. Here are the essential steps to follow:</p>

<ol>

<li>

<p>Define Selection Criteria: Establish clear criteria based on the trial's objectives, including:</p>

<ul>

<li>Patient Population: Assess the prevalence of the condition being studied within the site's catchment area. Higher prevalence rates can significantly enhance recruitment efforts, making it crucial to evaluate <a href="https://bioaccessla.com/blog/10-key-compliance-insights-for-class-1-devices-you-need-now">local health statistics</a>. For example, <a href="https://expertmarketresearch.com/reports/brazil-clinical-trials-market" rel="noopener noreferrer nofollow" target="_blank">Brazil is expected to report over 704,000 new cancer cases each year from 2023 to 2025</a>, emphasizing the significance of focusing on areas with appropriate patient demographics.</li>

<li>Infrastructure Evaluation: Assess the facilities, equipment, and staff qualifications of the location. Ensure that the location has the essential resources, including advanced medical technology and skilled personnel, to conduct the study efficiently.</li>

<li>Regulatory Experience: Seek locations with a proven track record of <a href="https://lek.com/insights/life-sciences-pharma/unlocking-brazils-clinical-trial-opportunity-strategic-roadmap" rel="noopener noreferrer nofollow" target="_blank">compliance with ANVISA regulations and ICH-GCP standards</a>. This experience is crucial for ensuring that the study complies with all regulatory standards and can promote smoother approval processes, particularly since the clinical trial site Brazil may encounter an approval process that extends up to 18 months.</li>

</ul>

</li>

<li>

<p>Conduct Feasibility Studies: Perform thorough <a href="https://bioaccessla.com/blog/10-key-insights-on-eap-regulations-for-bulgarias-clinical-trials">feasibility assessments</a> to gauge the site's capability to meet the study's requirements. This includes:</p>

<ul>

<li>Site Visits: Conduct on-site evaluations to observe the facilities firsthand and meet the research team, ensuring they align with the trial's needs.</li>

<li>Interviews with Investigators: Discuss their experience, <a href="https://bioaccessla.com/blog/10-benefits-of-clinical-trial-remote-monitoring-for-research-directors">patient recruitment strategies</a>, and commitment to the trial. Understanding their approach can provide insights into potential challenges and opportunities.</li>

</ul>

</li>

<li>

<p>Utilize Local Networks: Leverage local CROs, such as bioaccess®, to identify pre-qualified locations. These organizations often have established connections with locations and can offer valuable insights into their capabilities, enhancing the selection process. bioaccess® specializes in accelerating Phase I <a href="https://bioaccessla.com/br/services">first-in-human studies</a> in Latin America, providing 4-8 week ethics approvals and FDA/EMA-ready clinical data, which is essential for prompt execution.</p>

</li>

<li>

<p>Review Historical Performance: Examine the past performance of potential locations in earlier evaluations, concentrating on recruitment rates, data quality, and adherence to timelines. This data can help predict future performance and identify reliable partners.</p>

</li>

<li>

<p>Engage Stakeholders: Involve key participants, including investigators and personnel at the locations, in the selection process to ensure alignment with the study's goals and expectations. Their input can be invaluable in refining the selection criteria and ensuring a collaborative approach.</p>

</li>

</ol>

<p>By adhering to these procedures, failing to select the right research locations could jeopardize timelines and <a href="https://bioaccessla.com/cart">regulatory compliance</a>, ultimately hindering the introduction of vital therapies to the market. This strategy boosts the likelihood of hitting recruitment targets while keeping regulatory standards in check, paving the way for vital therapies to reach the market more smoothly. Considering that <a href="https://fortunebusinessinsights.com/brazil-clinical-trials-market-112310" rel="noopener noreferrer nofollow" target="_blank">the Brazilian market for healthcare studies is anticipated to achieve a projected income of USD 443.5 million by 2032</a>, the importance of selecting the right clinical trial site Brazil cannot be emphasized enough.</p>

<p><img alt="This flowchart outlines the steps to identify and evaluate clinical trial sites. Each box represents a key step in the process, and the arrows show the order in which to follow them. Start at the top and move down to ensure you cover all necessary aspects for successful site selection." src="https://images.tely.ai/telyai/wgxvvhad-this-flowchart-outlines-the-steps-to-identify-and-evaluate-clinical-trial-sites-each-box-represents-a-key-step-in-the-process-and-the-arrows-show-the-order-in-which-to-follow-them-start-at-the-top-and-move-down-to-ensure-you-cover-all-necessary-aspects-for-successful-site-selection.webp" title="This flowchart outlines the steps to identify and evaluate clinical trial sites. Each box represents a key step in the process, and the arrows show the order in which to follow them. Start at the top and move down to ensure you cover all necessary aspects for successful site selection."/></p>

<h2 id="assess-logistics-and-patient-recruitment-strategies">Assess Logistics and Patient Recruitment Strategies</h2>

<p>Identifying potential clinical research locations is just the beginning; the real challenge lies in logistics and patient recruitment. Let’s explore some key factors to consider:</p>

<ol>

<li>

<p>Logistical Considerations: Evaluate the <a href="https://bioaccessla.com/blog/10-common-ethics-submission-mistakes-in-australia-to-avoid">logistical capabilities of each site</a>, including:</p>

<ul>

<li>Supply Chain Management: Ensure the site can effectively manage the supply of investigational products, including storage and distribution requirements, in compliance with ICH-GCP standards.</li>

<li>Transportation: Assess the accessibility of the location for both patients and research staff, considering transportation options for participants, especially in rural areas where access might be limited.</li>

<li><a href="https://bioaccessla.com/blog/10-benefits-of-electronic-data-capture-for-clinical-trials">Data Management Systems</a>: Confirm that the site has robust data management systems in place to ensure accurate and timely data collection and reporting, facilitating <a href="https://bioaccessla.com/market-access">FDA-bridgeable data acceptance</a> for regulatory submissions.</li>

</ul>

</li>

<li>

<p><a href="https://bioaccessla.com/es/services">Patient Recruitment Strategies</a>: Develop effective <a href="https://openclinica.com/blog/seven-patient-recruitment-best-practices-used-by-leading-research-studies" rel="noopener noreferrer nofollow" target="_blank">patient recruitment strategies tailored to the local context</a>:</p>

<ul>

<li><a href="https://openclinica.com/blog/seven-patient-recruitment-best-practices-used-by-leading-research-studies" rel="noopener noreferrer nofollow" target="_blank">Community Engagement</a>: Build relationships with local healthcare providers and community organizations to raise awareness about the trial and its benefits, fostering trust and collaboration that can enhance recruitment outcomes.</li>

<li>Digital Outreach: Utilize social media and online platforms to reach potential participants, particularly younger demographics who may be more engaged online, thereby expanding the pool of candidates.</li>

<li>Patient Advocacy Groups: Collaborate with <a href="https://bioaccessla.com/blog/10-benefits-of-combining-regulatory-and-ethics-approval-in-australia">patient advocacy organizations</a> to tap into their networks, leveraging their influence to enhance enrollment efforts and ensure that patient needs are respected.</li>

</ul>

</li>

<li>

<p>Cultural Considerations: Understand the cultural nuances that may affect patient participation. Customize outreach messages to connect with the local community, addressing any issues or misunderstandings about studies, which can greatly influence enrollment rates.</p>

</li>

<li>

<p>Consider providing incentives for involvement, such as transportation reimbursement or compensation for time spent in the study, to improve enrollment rates. This approach acknowledges the value of participants' time and can lead to higher enrollment and retention rates.</p>

</li>

</ol>

<p>When you thoroughly evaluate logistics and implement effective patient recruitment strategies, sponsors can ensure that their chosen <a href="https://grandviewresearch.com/horizon/outlook/clinical-trial-patient-recruitment-services-market/brazil" rel="noopener noreferrer nofollow" target="_blank">clinical trial site in Brazil is well-equipped to enroll participants efficiently</a> and conduct studies successfully, capitalizing on the expanding market for medical research in Brazil, projected to reach USD 1,033.6 million by 2033. Without a strategic approach to logistics and recruitment, even the best research locations may fall short of their potential.</p>

<p><img alt="This mindmap starts with the main topic in the center and branches out into key areas to consider for successful clinical trials. Each branch represents a different aspect of logistics and recruitment, with further details provided in the sub-branches. Follow the connections to see how each factor contributes to the overall strategy." src="https://images.tely.ai/telyai/zskpovqz-this-mindmap-starts-with-the-main-topic-in-the-center-and-branches-out-into-key-areas-to-consider-for-successful-clinical-trials-each-branch-represents-a-different-aspect-of-logistics-and-recruitment-with-further-details-provided-in-the-sub-branches-follow-the-connections-to-see-how-each-factor-contributes-to-the-overall-strategy.webp" title="This mindmap starts with the main topic in the center and branches out into key areas to consider for successful clinical trials. Each branch represents a different aspect of logistics and recruitment, with further details provided in the sub-branches. Follow the connections to see how each factor contributes to the overall strategy."/></p>

<h2 id="establish-communication-and-collaboration-with-the-site">Establish Communication and Collaboration with the Site</h2>

<p><a href="https://bioaccessla.com/br/solutions">Effective communication</a> is not just beneficial; it is essential for the success of any clinical trial site in Brazil. Follow these <a href="https://bioaccessla.com/blog/10-benefits-of-electronic-data-capture-for-clinical-research">best practices to ensure your study runs smoothly</a>:</p>

<ol>

<li>Initial Meetings: Conduct <a href="https://globalforum.diaglobal.org/issue/june-2024/back-to-communication-basics-reducing-site-burden-and-establishing-a-sponsor-cro-of-choice-relationship-with-investigative-sites" rel="noopener noreferrer nofollow" target="_blank">preliminary meetings with site personnel</a> to discuss study objectives, expectations, and timelines. Make sure everyone is aligned on the goals and responsibilities of the study.</li>

<li><a href="https://careers.iconplc.com/blogs/2024-12/communication-strategies-for-sites-and-sponsors" rel="noopener noreferrer nofollow" target="_blank">Regular Updates</a>: Consider scheduling weekly or bi-weekly meetings, tailored to the complexity of your study, to keep everyone on track. Regular check-ins help monitor progress, address challenges, and provide necessary support.</li>

<li>Utilize Technology: Leverage technology to facilitate communication, such as project management tools and secure messaging platforms. Using these tools can really boost collaboration, making sure everyone stays in the loop with the latest updates.</li>

<li>Feedback Mechanisms: Establish <a href="https://globalforum.diaglobal.org/issue/june-2024/back-to-communication-basics-reducing-site-burden-and-establishing-a-sponsor-cro-of-choice-relationship-with-investigative-sites" rel="noopener noreferrer nofollow" target="_blank">feedback mechanisms to encourage open communication</a>. Create an environment where staff feel comfortable sharing concerns or suggestions for enhancement.</li>

<li><a href="https://bioaccessla.com/blog/10-essential-clinical-trial-agreement-requirements-in-serbia">Training and Support</a>: Offer instruction and continuous assistance to personnel to ensure they are adequately prepared to execute the study in accordance with protocol. This can include training on data collection methods, compliance requirements, and <a href="https://bioaccessla.com/testimonials">patient engagement strategies</a>.</li>

<li><a href="https://bioaccessla.com/blog/10-croatia-ethics-committee-so-ps-every-sponsor-must-know">Celebrate Milestones</a>: Acknowledge and honor achievements reached during the study to promote a positive working relationship and inspire personnel.</li>

</ol>

<p>Without effective communication, misunderstandings can derail the study's progress. When sponsors prioritize strong communication and collaboration with the <a href="https://bioaccessla.com/br/about">clinical trial site Brazil</a>, they not only enhance the likelihood of success but also ensure that the study runs smoothly and efficiently.</p>

<p><img alt="This flowchart outlines the steps to improve communication and collaboration at a clinical trial site. Each box represents a key practice, and the arrows show how these practices connect to create a successful communication strategy." src="https://images.tely.ai/telyai/gjciscev-this-flowchart-outlines-the-steps-to-improve-communication-and-collaboration-at-a-clinical-trial-site-each-box-represents-a-key-practice-and-the-arrows-show-how-these-practices-connect-to-create-a-successful-communication-strategy.webp" title="This flowchart outlines the steps to improve communication and collaboration at a clinical trial site. Each box represents a key practice, and the arrows show how these practices connect to create a successful communication strategy."/></p>

<h2 id="conclusion">Conclusion</h2>

<p>Selecting the right clinical trial site in Brazil is not just important; it can make or break the success of your research initiatives. Understanding the regulatory framework and evaluating potential sites are essential. Implementing effective communication strategies is equally crucial. By focusing on these elements, sponsors can significantly enhance their chances of conducting successful trials that meet regulatory standards and achieve operational excellence.</p>

<p>The article emphasizes several key factors that contribute to successful site selection. First, a thorough understanding of Brazil's regulatory landscape, including compliance with ANVISA and ICH-GCP standards, is crucial. Second, the importance of defining selection criteria, conducting feasibility studies, and leveraging local networks cannot be overstated. Finally, establishing strong communication and collaboration with site personnel ensures that all stakeholders are aligned and can navigate challenges effectively.</p>

<p>As Brazil's prominence as a hub for clinical trials grows, how can stakeholders adopt a strategic approach to site selection? By prioritizing regulatory compliance, logistical efficiency, and effective patient recruitment strategies, researchers can capitalize on Brazil's unique advantages for early-stage clinical trials. This proactive approach will not only streamline the trial process but also contribute to the timely introduction of innovative therapies to the market, ultimately benefiting both patients and the broader healthcare landscape.</p>

<p><iframe frameborder="0" height="300px" loading="lazy" src="https://iframe.tely.ai/cta/eyJhcnRpY2xlX2lkIjogIjY5ZjNlZDFhOTJiYTZiMzkyM2RhOGQ3OCIsICJjb21wYW55X2lkIjogIjY2OTk4NmYwMzM1YWQwNDI3ZTVmNTdlMyIsICJpbmRleCI6IG51bGwsICJ0eXBlIjogImFydGljbGUifQ==" width="100%"></iframe></p>

<h2 id="frequently-asked-questions">Frequently Asked Questions</h2>

<p><strong>What is the approval process for clinical trials in Brazil?</strong></p>

<p>Clinical research applications must be submitted to ANVISA, which has a strict limit of 90 business days for approval under new regulations effective from January 1, 2025. It is crucial to prepare all necessary documentation, including the clinical study protocol and informed consent forms, according to ANVISA's guidelines.</p>

<p><strong>What compliance requirements must be met for clinical trials in Brazil?</strong></p>

<p>Studies must comply with ICH-GCP (International Council for Harmonisation – Good Clinical Practice) standards, which are essential for protecting the rights, safety, and well-being of participants. Adhering to these standards not only fulfills regulatory requirements but also enhances the credibility of the collected data.</p>

<p><strong>Is ethics committee approval required for clinical trials in Brazil?</strong></p>

<p>Yes, in addition to ANVISA approval, clinical trials must receive endorsement from a local ethics committee (Comitê de Ética em Pesquisa – CEP). This committee evaluates the ethical aspects of the study to ensure participant safety and adherence to ethical standards.</p>

<p><strong>What documentation is required for the approval process in Brazil?</strong></p>

<p>Thorough documentation is essential for both ANVISA and the ethics committee review processes. This includes preclinical data, study protocols, and investigator qualifications, all of which must be meticulously prepared to facilitate a smooth approval process.</p>

<p><strong>Are there any recent regulatory changes affecting clinical trials in Brazil?</strong></p>

<p>Yes, recent legislative changes, such as Law No. 14.874/2024, aim to streamline the approval process and reduce bureaucratic hurdles. Staying informed about these changes can provide a strategic advantage in site selection and study execution, allowing for quicker commencement of research activities.</p>

<p><strong>How can understanding Brazil's regulatory framework benefit sponsors of clinical trials?</strong></p>

<p>By mastering the regulatory nuances in Brazil, sponsors can position themselves for a more efficient and effective research journey at clinical trial sites, ultimately enhancing the speed and success of their early-stage clinical trials.</p>

<h2 id="list-of-sources">List of Sources</h2>

<ol>

<li>Understand Brazil's Regulatory Framework for Clinical Trials

<ul>

<li>Brazil Just Changed The Rules For Clinical Trial Approvals — What Sponsors Need To Know | bioaccess® (https://bioaccessla.com/blog/brazil-anvisa-parallel-review-clinical-trial-approvals-2026)</li>

<li>Brazil Clinical Trials Market Size, Share | Analysis Report [2032] (https://fortunebusinessinsights.com/brazil-clinical-trials-market-112310)</li>

<li>Brazil Clinical Trials Market Size & Outlook, 2033 (https://grandviewresearch.com/horizon/outlook/clinical-trials-market/brazil)</li>

</ul>

</li>

<li>Identify and Evaluate Potential Clinical Trial Sites

<ul>

<li>Brazil Clinical Trials Market Size, Share | Analysis Report [2032] (https://fortunebusinessinsights.com/brazil-clinical-trials-market-112310)</li>

<li>Brazil Clinical Trials Market Size & Outlook, 2033 (https://grandviewresearch.com/horizon/outlook/clinical-trials-market/brazil)</li>

<li>Unlocking Brazil’s Clinical Trial Opportunity: A Strategic Roadmap for Healthcare Leaders (https://lek.com/insights/life-sciences-pharma/unlocking-brazils-clinical-trial-opportunity-strategic-roadmap)</li>

<li>Brazil Clinical Trials Market Size & Future Growth 2035 (https://expertmarketresearch.com/reports/brazil-clinical-trials-market)</li>

<li>Patient Engagement Quotes: For Every Purpose & Audience (https://nclusiv.co.uk/edi-consulting/f/patient-engagement-quotes-for-every-purpose-audience)</li>

</ul>

</li>

<li>Assess Logistics and Patient Recruitment Strategies

<ul>

<li>Brazil Clinical Trials Market Size & Outlook, 2033 (https://grandviewresearch.com/horizon/outlook/clinical-trials-market/brazil)</li>

<li>10 Inspiring Patient Experience Quotes | Relias (https://relias.com/blog/patient-experience-quotes)</li>

<li>Brazil Clinical Trial Patient Recruitment Services Market Size & Outlook, 2033 (https://grandviewresearch.com/horizon/outlook/clinical-trial-patient-recruitment-services-market/brazil)</li>

<li>Seven Best Practices For Clinical Trial Patient Recruitment (https://openclinica.com/blog/seven-patient-recruitment-best-practices-used-by-leading-research-studies)</li>

</ul>

</li>

<li>Establish Communication and Collaboration with the Site

<ul>

<li>Top 5 Alarming Statistics on Clinical Trial Site Selection (https://biobostonconsulting.com/top-5-alarming-statistics-you-must-know-about-clinical-trial-site-selection)</li>

<li>Communication Strategies for Sites and Sponsors in Clinical Research | ICON news and blogs (https://careers.iconplc.com/blogs/2024-12/communication-strategies-for-sites-and-sponsors)</li>

<li>Back to (Communication) Basics: Reducing Site Burden and Establishing a Sponsor/CRO-of-Choice Relationship with Investigative Sites (https://globalforum.diaglobal.org/issue/june-2024/back-to-communication-basics-reducing-site-burden-and-establishing-a-sponsor-cro-of-choice-relationship-with-investigative-sites)</li>

<li>25+ useful clinical trial recruitment statistics for better results (https://antidote.me/blog/25-useful-clinical-trial-recruitment-statistics-for-better-results)</li>

</ul>

</li>

</ol>

<script type="application/ld+json">{"@context": "https://schema.org", "@type": "FAQPage", "mainEntity": [{"@type": "Question", "name": "What is the approval process for clinical trials in Brazil?", "acceptedAnswer": {"@type": "Answer", "text": "Clinical research applications must be submitted to ANVISA, which has a strict limit of 90 business days for approval under new regulations effective from January 1, 2025. It is crucial to prepare all necessary documentation, including the clinical study protocol and informed consent forms, according to ANVISA's guidelines."}}, {"@type": "Question", "name": "What compliance requirements must be met for clinical trials in Brazil?", "acceptedAnswer": {"@type": "Answer", "text": "Studies must comply with ICH-GCP (International Council for Harmonisation – Good Clinical Practice) standards, which are essential for protecting the rights, safety, and well-being of participants. 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Navigating Brazil's evolving regulatory landscape can be daunting for sponsors. Understanding the nuances of site selection is essential for success. This guide will help you identify and evaluate potential sites while tackling the logistical and recruitment challenges you might face. nnSo, how can you make sure your choices meet regulatory standards and boost patient recruitment in this ever-changing market?nn## Understand Brazil's Regulatory Framework for Clinical TrialsnnBefore selecting a clinical trial site in Brazil, it is essential to grasp the regulatory landscape set by ANVISA for success. Key components include:nn1. [Approval Process](https://bioaccessla.com/blog/10-essential-clinical-trial-coordinator-duties-for-research-success): [Clinical research applications must be submitted to ANVISA](https://grandviewresearch.com/horizon/outlook/clinical-trials-market/brazil), which now has a strict limit of 90 business days for approval under the new regulations effective from January 1, 2025. It's vital to meticulously prepare all necessary documentation, such as the clinical study protocol and informed consent forms, in line with ANVISA's guidelines.n2. [Compliance Requirements](https://bioaccessla.com/blog/10-capa-corrective-action-preventive-action-strategies-for-clinical-research): Studies must adhere to ICH-GCP (International Council for Harmonisation – Good Clinical Practice) standards, crucial for protecting the rights, safety, and well-being of participants. Following these standards is not just a regulatory necessity; it also boosts the credibility of the data collected.n3. [Ethics Committee Approval](https://bioaccessla.com/blog/10-essential-features-of-clinical-trial-data-software-for-success): In addition to ANVISA, studies must receive endorsement from a local ethics committee (Comitê de Ética em Pesquisa – CEP). This process evaluates the ethical aspects of the study, ensuring participant safety and adherence to ethical standards.n4. Documentation: Thorough documentation is essential for the review processes of both ANVISA and the ethics committee. It includes preclinical data, study protocols, and investigator qualifications, which must be thoroughly prepared to facilitate a smooth approval process.n5. Regulatory Changes: Stay informed about [recent legislative changes, such as Law No. 14.874/2024](https://grandviewresearch.com/horizon/outlook/clinical-trials-market/brazil), which aims to streamline the approval process and reduce bureaucratic hurdles. Grasping these transformations can offer a strategic edge in location selection and study execution, enabling quicker commencement of research activities.nnBy mastering these regulatory nuances, sponsors position themselves for a more efficient and effective research journey at a clinical trial site in Brazil.nn![This flowchart guides you through the essential steps for navigating the regulatory landscape for clinical trials in Brazil. Each box represents a key component of the process, and the arrows show how they connect and flow into one another.](https://images.tely.ai/telyai/rtsjkopf-this-flowchart-guides-you-through-the-essential-steps-for-navigating-the-regulatory-landscape-for-clinical-trials-in-brazil-each-box-represents-a-key-component-of-the-process-and-the-arrows-show-how-they-connect-and-flow-into-one-another.webp "This flowchart guides you through the essential steps for navigating the regulatory landscape for clinical trials in Brazil. Each box represents a key component of the process, and the arrows show how they connect and flow into one another.")nn## Identify and Evaluate Potential Clinical Trial SitesnnIdentifying the right [clinical trial site Brazil](https://bioaccessla.com/br) is a complex challenge that requires a strategic approach to ensure successful outcomes. Here are the essential steps to follow:nn1. Define Selection Criteria: Establish clear criteria based on the trial's objectives, including:nn – Patient Population: Assess the prevalence of the condition being studied within the site's catchment area. Higher prevalence rates can significantly enhance recruitment efforts, making it crucial to evaluate [local health statistics](https://bioaccessla.com/blog/10-key-compliance-insights-for-class-1-devices-you-need-now). For example, [Brazil is expected to report over 704,000 new cancer cases each year from 2023 to 2025](https://expertmarketresearch.com/reports/brazil-clinical-trials-market), emphasizing the significance of focusing on areas with appropriate patient demographics.n – Infrastructure Evaluation: Assess the facilities, equipment, and staff qualifications of the location. Ensure that the location has the essential resources, including advanced medical technology and skilled personnel, to conduct the study efficiently.n – Regulatory Experience: Seek locations with a proven track record of [compliance with ANVISA regulations and ICH-GCP standards](https://lek.com/insights/life-sciences-pharma/unlocking-brazils-clinical-trial-opportunity-strategic-roadmap). This experience is crucial for ensuring that the study complies with all regulatory standards and can promote smoother approval processes, particularly since the clinical trial site Brazil may encounter an approval process that extends up to 18 months.n2. Conduct Feasibility Studies: Perform thorough [feasibility assessments](https://bioaccessla.com/blog/10-key-insights-on-eap-regulations-for-bulgarias-clinical-trials) to gauge the site's capability to meet the study's requirements. This includes:nn – Site Visits: Conduct on-site evaluations to observe the facilities firsthand and meet the research team, ensuring they align with the trial's needs.n – Interviews with Investigators: Discuss their experience, [patient recruitment strategies](https://bioaccessla.com/blog/10-benefits-of-clinical-trial-remote-monitoring-for-research-directors), and commitment to the trial. Understanding their approach can provide insights into potential challenges and opportunities.n3. Utilize Local Networks: Leverage local CROs, such as bioaccess®, to identify pre-qualified locations. These organizations often have established connections with locations and can offer valuable insights into their capabilities, enhancing the selection process. bioaccess® specializes in accelerating Phase I [first-in-human studies](https://bioaccessla.com/br/services) in Latin America, providing 4-8 week ethics approvals and FDA/EMA-ready clinical data, which is essential for prompt execution.n4. Review Historical Performance: Examine the past performance of potential locations in earlier evaluations, concentrating on recruitment rates, data quality, and adherence to timelines. This data can help predict future performance and identify reliable partners.n5. Engage Stakeholders: Involve key participants, including investigators and personnel at the locations, in the selection process to ensure alignment with the study's goals and expectations. Their input can be invaluable in refining the selection criteria and ensuring a collaborative approach.nnBy adhering to these procedures, failing to select the right research locations could jeopardize timelines and [regulatory compliance](https://bioaccessla.com/cart), ultimately hindering the introduction of vital therapies to the market. This strategy boosts the likelihood of hitting recruitment targets while keeping regulatory standards in check, paving the way for vital therapies to reach the market more smoothly. Considering that [the Brazilian market for healthcare studies is anticipated to achieve a projected income of USD 443.5 million by 2032](https://fortunebusinessinsights.com/brazil-clinical-trials-market-112310), the importance of selecting the right clinical trial site Brazil cannot be emphasized enough.nn![This flowchart outlines the steps to identify and evaluate clinical trial sites. Each box represents a key step in the process, and the arrows show the order in which to follow them. Start at the top and move down to ensure you cover all necessary aspects for successful site selection.](https://images.tely.ai/telyai/wgxvvhad-this-flowchart-outlines-the-steps-to-identify-and-evaluate-clinical-trial-sites-each-box-represents-a-key-step-in-the-process-and-the-arrows-show-the-order-in-which-to-follow-them-start-at-the-top-and-move-down-to-ensure-you-cover-all-necessary-aspects-for-successful-site-selection.webp "This flowchart outlines the steps to identify and evaluate clinical trial sites. Each box represents a key step in the process, and the arrows show the order in which to follow them. Start at the top and move down to ensure you cover all necessary aspects for successful site selection.")nn## Assess Logistics and Patient Recruitment StrategiesnnIdentifying potential clinical research locations is just the beginning; the real challenge lies in logistics and patient recruitment. Let’s explore some key factors to consider:nn1. Logistical Considerations: Evaluate the [logistical capabilities of each site](https://bioaccessla.com/blog/10-common-ethics-submission-mistakes-in-australia-to-avoid), including:nn – Supply Chain Management: Ensure the site can effectively manage the supply of investigational products, including storage and distribution requirements, in compliance with ICH-GCP standards.n – Transportation: Assess the accessibility of the location for both patients and research staff, considering transportation options for participants, especially in rural areas where access might be limited.n – [Data Management Systems](https://bioaccessla.com/blog/10-benefits-of-electronic-data-capture-for-clinical-trials): Confirm that the site has robust data management systems in place to ensure accurate and timely data collection and reporting, facilitating [FDA-bridgeable data acceptance](https://bioaccessla.com/market-access) for regulatory submissions.n2. [Patient Recruitment Strategies](https://bioaccessla.com/es/services): Develop effective [patient recruitment strategies tailored to the local context](https://openclinica.com/blog/seven-patient-recruitment-best-practices-used-by-leading-research-studies):nn – [Community Engagement](https://openclinica.com/blog/seven-patient-recruitment-best-practices-used-by-leading-research-studies): Build relationships with local healthcare providers and community organizations to raise awareness about the trial and its benefits, fostering trust and collaboration that can enhance recruitment outcomes.n – Digital Outreach: Utilize social media and online platforms to reach potential participants, particularly younger demographics who may be more engaged online, thereby expanding the pool of candidates.n – Patient Advocacy Groups: Collaborate with [patient advocacy organizations](https://bioaccessla.com/blog/10-benefits-of-combining-regulatory-and-ethics-approval-in-australia) to tap into their networks, leveraging their influence to enhance enrollment efforts and ensure that patient needs are respected.n3. Cultural Considerations: Understand the cultural nuances that may affect patient participation. Customize outreach messages to connect with the local community, addressing any issues or misunderstandings about studies, which can greatly influence enrollment rates.n4. Consider providing incentives for involvement, such as transportation reimbursement or compensation for time spent in the study, to improve enrollment rates. This approach acknowledges the value of participants' time and can lead to higher enrollment and retention rates.nnWhen you thoroughly evaluate logistics and implement effective patient recruitment strategies, sponsors can ensure that their chosen [clinical trial site in Brazil is well-equipped to enroll participants efficiently](https://grandviewresearch.com/horizon/outlook/clinical-trial-patient-recruitment-services-market/brazil) and conduct studies successfully, capitalizing on the expanding market for medical research in Brazil, projected to reach USD 1,033.6 million by 2033. Without a strategic approach to logistics and recruitment, even the best research locations may fall short of their potential.nn![This mindmap starts with the main topic in the center and branches out into key areas to consider for successful clinical trials. Each branch represents a different aspect of logistics and recruitment, with further details provided in the sub-branches. Follow the connections to see how each factor contributes to the overall strategy.](https://images.tely.ai/telyai/zskpovqz-this-mindmap-starts-with-the-main-topic-in-the-center-and-branches-out-into-key-areas-to-consider-for-successful-clinical-trials-each-branch-represents-a-different-aspect-of-logistics-and-recruitment-with-further-details-provided-in-the-sub-branches-follow-the-connections-to-see-how-each-factor-contributes-to-the-overall-strategy.webp "This mindmap starts with the main topic in the center and branches out into key areas to consider for successful clinical trials. Each branch represents a different aspect of logistics and recruitment, with further details provided in the sub-branches. Follow the connections to see how each factor contributes to the overall strategy.")nn## Establish Communication and Collaboration with the Sitenn[Effective communication](https://bioaccessla.com/br/solutions) is not just beneficial; it is essential for the success of any clinical trial site in Brazil. Follow these [best practices to ensure your study runs smoothly](https://bioaccessla.com/blog/10-benefits-of-electronic-data-capture-for-clinical-research):nn1. Initial Meetings: Conduct [preliminary meetings with site personnel](https://globalforum.diaglobal.org/issue/june-2024/back-to-communication-basics-reducing-site-burden-and-establishing-a-sponsor-cro-of-choice-relationship-with-investigative-sites) to discuss study objectives, expectations, and timelines. Make sure everyone is aligned on the goals and responsibilities of the study.n2. [Regular Updates](https://careers.iconplc.com/blogs/2024-12/communication-strategies-for-sites-and-sponsors): Consider scheduling weekly or bi-weekly meetings, tailored to the complexity of your study, to keep everyone on track. Regular check-ins help monitor progress, address challenges, and provide necessary support.n3. Utilize Technology: Leverage technology to facilitate communication, such as project management tools and secure messaging platforms. Using these tools can really boost collaboration, making sure everyone stays in the loop with the latest updates.n4. Feedback Mechanisms: Establish [feedback mechanisms to encourage open communication](https://globalforum.diaglobal.org/issue/june-2024/back-to-communication-basics-reducing-site-burden-and-establishing-a-sponsor-cro-of-choice-relationship-with-investigative-sites). Create an environment where staff feel comfortable sharing concerns or suggestions for enhancement.n5. [Training and Support](https://bioaccessla.com/blog/10-essential-clinical-trial-agreement-requirements-in-serbia): Offer instruction and continuous assistance to personnel to ensure they are adequately prepared to execute the study in accordance with protocol. This can include training on data collection methods, compliance requirements, and [patient engagement strategies](https://bioaccessla.com/testimonials).n6. [Celebrate Milestones](https://bioaccessla.com/blog/10-croatia-ethics-committee-so-ps-every-sponsor-must-know): Acknowledge and honor achievements reached during the study to promote a positive working relationship and inspire personnel.nnWithout effective communication, misunderstandings can derail the study's progress. When sponsors prioritize strong communication and collaboration with the [clinical trial site Brazil](https://bioaccessla.com/br/about), they not only enhance the likelihood of success but also ensure that the study runs smoothly and efficiently.nn![This flowchart outlines the steps to improve communication and collaboration at a clinical trial site. Each box represents a key practice, and the arrows show how these practices connect to create a successful communication strategy.](https://images.tely.ai/telyai/gjciscev-this-flowchart-outlines-the-steps-to-improve-communication-and-collaboration-at-a-clinical-trial-site-each-box-represents-a-key-practice-and-the-arrows-show-how-these-practices-connect-to-create-a-successful-communication-strategy.webp "This flowchart outlines the steps to improve communication and collaboration at a clinical trial site. Each box represents a key practice, and the arrows show how these practices connect to create a successful communication strategy.")nn## ConclusionnSelecting the right clinical trial site in Brazil is not just important; it can make or break the success of your research initiatives. Understanding the regulatory framework and evaluating potential sites are essential. Implementing effective communication strategies is equally crucial. By focusing on these elements, sponsors can significantly enhance their chances of conducting successful trials that meet regulatory standards and achieve operational excellence. nnThe article emphasizes several key factors that contribute to successful site selection. First, a thorough understanding of Brazil's regulatory landscape, including compliance with ANVISA and ICH-GCP standards, is crucial. Second, the importance of defining selection criteria, conducting feasibility studies, and leveraging local networks cannot be overstated. Finally, establishing strong communication and collaboration with site personnel ensures that all stakeholders are aligned and can navigate challenges effectively. nnAs Brazil's prominence as a hub for clinical trials grows, how can stakeholders adopt a strategic approach to site selection? By prioritizing regulatory compliance, logistical efficiency, and effective patient recruitment strategies, researchers can capitalize on Brazil's unique advantages for early-stage clinical trials. This proactive approach will not only streamline the trial process but also contribute to the timely introduction of innovative therapies to the market, ultimately benefiting both patients and the broader healthcare landscape.nn::iframe[https://iframe.tely.ai/cta/eyJhcnRpY2xlX2lkIjogIjY5ZjNlZDFhOTJiYTZiMzkyM2RhOGQ3OCIsICJjb21wYW55X2lkIjogIjY2OTk4NmYwMzM1YWQwNDI3ZTVmNTdlMyIsICJpbmRleCI6IG51bGwsICJ0eXBlIjogImFydGljbGUifQ==]{width="100%" height="300px"}", "image": ["https://images.tely.ai/telyai/rtsjkopf-this-flowchart-guides-you-through-the-essential-steps-for-navigating-the-regulatory-landscape-for-clinical-trials-in-brazil-each-box-represents-a-key-component-of-the-process-and-the-arrows-show-how-they-connect-and-flow-into-one-another.webp", "https://images.tely.ai/telyai/wgxvvhad-this-flowchart-outlines-the-steps-to-identify-and-evaluate-clinical-trial-sites-each-box-represents-a-key-step-in-the-process-and-the-arrows-show-the-order-in-which-to-follow-them-start-at-the-top-and-move-down-to-ensure-you-cover-all-necessary-aspects-for-successful-site-selection.webp", "https://images.tely.ai/telyai/zskpovqz-this-mindmap-starts-with-the-main-topic-in-the-center-and-branches-out-into-key-areas-to-consider-for-successful-clinical-trials-each-branch-represents-a-different-aspect-of-logistics-and-recruitment-with-further-details-provided-in-the-sub-branches-follow-the-connections-to-see-how-each-factor-contributes-to-the-overall-strategy.webp", "https://images.tely.ai/telyai/gjciscev-this-flowchart-outlines-the-steps-to-improve-communication-and-collaboration-at-a-clinical-trial-site-each-box-represents-a-key-practice-and-the-arrows-show-how-these-practices-connect-to-create-a-successful-communication-strategy.webp"], "inLanguage": "en", "author": {"@type": "Organization", "name": "bioaccess®"}, "publisher": {"@type": "Organization", "name": "bioaccess®", "url": "https://bioaccessla.com"}}</script>

June 29, 2026
Understanding Clinical Trial Hotspots in Latin America: An In-Depth Tutorial
Introduction

Latin America is rapidly establishing itself as a key player in the global clinical trial landscape, driven by a confluence of factors that make it an attractive destination for medical research. With its diverse patient populations, lower operational costs, and evolving regulatory frameworks, countries such as Brazil, Mexico, and Colombia are emerging as hotspots for innovative clinical studies.

However, navigating this promising terrain comes with its own set of challenges, including regulatory complexities and communication barriers that can hinder collaboration with international sponsors.

This article delves into the dynamics shaping Latin America’s rise in the clinical trial sector, highlighting the opportunities and obstacles that define this vibrant market, while emphasizing the importance of strategic partnerships and technological advancements in enhancing trial efficiency and accessibility.

The Rise of Latin America as a Clinical Trial Destination

Latin America has emerged as one of the , driven by several key factors. The region boasts a diverse patient population, essential for obtaining varied and representative data. Additionally, the .

These benefits are enhanced by a developing regulatory framework that actively supports . However, Medtech companies encounter significant challenges, including:
- Professionalism issues
- Language barriers
- Fragmented resources
These challenges can impede seamless communication and collaboration with . Each nation has developed robust healthcare infrastructures and a that are attractive locations for global sponsors.

Notably, , reflecting the country’s commitment to fostering innovation in healthcare. Successful partnerships, like the one between Greenlight Guru and bioaccess™, demonstrate the potential to expedite Medtech innovations and studies in Latin America. Furthermore, initiatives backed by local health agencies, such as the , establish Barranquilla as a prominent location for .

The impressive results from GlobalCare Clinical Trials, in partnership with bioaccess™, demonstrate a remarkable over 50% reduction in recruitment time and a 95% retention rate. As a testament to this trend, Flow-FX’s , delivering intraosseous antibiotics in Colombia, led by Dr. Carlos Severini, exemplifies the success of these strategies. With these components merged and acknowledging current obstacles, the region is positioned as a competitive environment for carrying out studies, particularly as that draw considerable investment and focus from the global scientific community.

Identifying Key Hotspots for Clinical Trials in Latin America

Brazil, Mexico, and Colombia are recognized as , each offering distinct benefits that attract research efforts. Brazil stands out due to its , which facilitate the recruitment of varied patient populations. According to recent reports, Brazil continues to lead the region in research activity, with significant growth observed in , which are essential for assessing the effectiveness of new treatments.

In fact, in Latin America are anticipated to experience significant growth in the research market, especially in Phase III, fueled by the expansion of and positive patient-physician relationships. Mexico, in contrast, features a , leading to a significant number of studies involving human subjects. In 2023, Mexico was emphasized for its strategic positioning in the research market, especially because of its robust partnership between patients and doctors.

As Dr. Larissa Aviles-Santa, Director of the Division of Clinical and Health Services Research, observes, ‘The success of depends on the collaborative efforts between researchers and local healthcare providers.’ Meanwhile, Colombia has emerged as a clinical trial hotspot in Latin America, owing to its . The nation has shown a dedication to promoting medical studies, which is evident in the .

Significantly, Dr. John B. Simpson, CEO of Avinger, highlighted the satisfactory experience conducting OCT-guided atherectomy trials at a site in Cali, Colombia, demonstrating the . Thorough research management services, including feasibility studies, site selection, compliance reviews, setup, and project management, are essential for navigating the complexities of medical research in these regions. Additionally, INVIMA, Colombia’s National Food and Drug Surveillance Institute, plays a vital role in overseeing research studies, ensuring adherence to national standards and facilitating the importation of investigational devices.

These areas not only offer access to large patient groups but also gain from a pool of skilled experts proficient at managing studies efficiently. As the landscape of medical research evolves, staying informed about and leveraging market intelligence is crucial for organizations aiming to maximize their recruitment strategies.

Navigating Regulatory Challenges in Latin American Clinical Trials

Navigating the regulatory environment in requires a comprehensive understanding of both local laws and international standards, as each nation has its appointed supervising research studies. In Brazil, this responsibility falls to ANVISA, while COFEPRIS serves a similar function in Mexico. Researchers must prioritize adherence to and to reduce the risk of delays or complications in the research process.

Working with local specialists and regulatory advisors is crucial, as their insights can aid in smoother navigation through these regulatory challenges, ensuring studies not only follow ethical standards but also prioritize . In Colombia, INVIMA functions as the national , categorized as a Level 4 health authority by PAHO/WHO, supervising and clinical study compliance. Our service capabilities encompass feasibility studies and site selection, which are essential for successful project initiation.

Additionally, we offer extensive project management and monitoring services, ensuring that all facets of the study are conducted efficiently and in compliance with . With the Colombian government striving to improve its medical investigation environment to meet international standards by 2031, the potential for growth in the region is substantial. Experts predict that Colombia could emerge as one of the , witnessing over 100 new clinical trials annually and generating close to $500 million in economic gains per year.

However, barriers persist, such as the and an inadequate regulatory context. Henry L. Gómez from Oncosalud-AUNA notes, “the and inadequate regulatory context are barriers found in Latin America; however, medical oncologists perceive the real potential of the region.” Furthermore, the importance of carrying out local studies in low and middle-income countries has been emphasized, particularly its effect on altering healthcare practices, underscoring the necessity for access to academic study groups.

Our reporting processes ensure that study status, inventory, and adverse events are meticulously documented, providing transparency and accountability throughout the study.

Leveraging Technology for Enhanced Clinical Trial Efficiency

The incorporation of technology into medical studies has led to . Tools such as , , and facilitate real-time data collection and enhance communication with participants. Recent advancements in EDC systems are streamlining workflows and improving data accuracy, which is critical given that only 5% of patients completed all seven modules of post-discharge requirements despite 84% completing at least one additional module.

Moreover, continuous initiatives to implement are essential for improving electronic healthcare information exchange, thus aiding the incorporation of technology in medical studies. Leveraging can significantly enhance patient recruitment and retention strategies by enabling researchers to identify and engage eligible candidates more effectively. The emergence of is especially significant, as it enables researchers to connect with broader patient groups, including individuals in distant locations, thereby enhancing participation rates.

As emphasized by Orri and colleagues in their 2014 REMOTE study, the —ranging from social media to online health forums—has proven effective in recruiting participants and managing their involvement through Internet-based consent and surveys. Additionally, the case study titled ‘Future Directions for E-Technologies in Clinical Trials’ underscores the necessity for to address the challenges associated with integrating e-technologies. These developments emphasize the necessity for medical researchers to adopt innovative digital solutions to meet the growing demand for new evidence.

Ensuring Equitable Access to Clinical Trials in Latin America

Fair access to research studies is crucial for promoting medical advancements and improving health results among various communities. In Latin America, where regulatory timelines and political instability present significant challenges, it is crucial to implement effective strategies in that promote inclusivity.

Colombia is recognized as one of the , standing out as a leading destination for due to its competitive advantages, including:
- compared to North America and Western Europe
- Rapid regulatory review processes of 90-120 days for
- A ranked among the best globally
Furthermore, investments in R&D benefit from substantial tax incentives, including a 100% tax deduction and various credits, making it economically advantageous for sponsors. Key barriers to participation, such as transportation issues, language differences, and socioeconomic disparities, must be addressed proactively. Engaging local communities and stakeholders is essential to raise awareness about the significance of clinical trials, particularly among underrepresented groups.

Initiatives such as the American Consortium for the Investigation of Lung Cancer (CLICAP), established in 2011, exemplify the potential of . As CLICAP states, “Our work aims to enhance lung cancer studies in South America,” emphasizing the consortium’s dedication to this cause. Furthermore, the involvement of experts like Juliana Giacomazzi from the highlights collaborative efforts to tackle these challenges.

The rigorous ICH/GCP certification process that hospitals must undergo before conducting medical studies ensures high-quality standards. The development of and the provision of support services can significantly boost recruitment efforts. By ensuring that medical studies reflect the diverse demographics they intend to serve, we can cultivate a more inclusive environment that benefits all participants.

Moreover, media attention from Clinical Leader highlights the increasing acknowledgment of research studies in South America, underscoring the significance of as part of a strong research ecosystem. Notably, Brazil’s contribution of 1,561 citable documents in 2020, representing 45.8% of the region’s total, underscores the need for ongoing efforts to ensure equitable access to clinical trials across Latin America.

Conclusion

Latin America is emerging as a significant player in the global clinical trial landscape, driven by its diverse patient populations, lower operational costs, and supportive regulatory frameworks. Countries such as Brazil, Mexico, and Colombia are at the forefront, each offering unique advantages that enhance their attractiveness for clinical research. However, the journey is not without its challenges, including regulatory complexities and communication barriers that require careful navigation.

The importance of strategic partnerships and technological advancements cannot be overstated. Collaborative efforts among local healthcare providers and international sponsors are essential for overcoming obstacles and maximizing the potential of the region. Moreover, integrating technology into clinical trials has proven to enhance efficiency, improve patient engagement, and streamline data collection, ultimately leading to more successful outcomes.

As Latin America continues to develop its clinical research capabilities, the focus on equitable access remains paramount. Addressing barriers to participation and fostering community engagement will ensure that clinical trials reflect the diverse demographics they aim to serve. By prioritizing inclusivity and leveraging the region’s strengths, the future of clinical trials in Latin America appears not only promising but also pivotal for advancing global medical research. The potential for growth and innovation in this dynamic landscape is substantial, positioning Latin America as a competitive and appealing destination for clinical trials on the world stage.

Frequently Asked Questions

Why is Latin America considered a hotspot for clinical trials?

Latin America is recognized as a hotspot for clinical trials due to its diverse patient population, lower operational expenses in countries like Brazil, Mexico, and Argentina, and a developing regulatory framework that supports medical studies.

What challenges do Medtech companies face in Latin America?

Medtech companies encounter challenges such as regulatory hurdles, professionalism issues, language barriers, and fragmented resources, which can hinder effective communication and collaboration with American clinical research clients.

What factors contribute to Brazil’s status as a clinical trial hotspot?

Brazil’s robust healthcare infrastructure and diverse patient demographics facilitate the recruitment of varied patient populations, leading to significant research activity, particularly in Phase III studies.

How does Mexico support clinical trials?

Mexico has a favorable regulatory environment that promotes pharmaceutical research, resulting in a high number of studies involving human subjects and strong partnerships between patients and healthcare providers.

What role does Colombia play in the clinical trial landscape?

Colombia has emerged as a clinical trial hotspot due to supportive governmental policies, competitive costs, and a growing number of experiments being conducted, backed by effective partnerships with local CROs.

What is the significance of partnerships in conducting clinical trials in Latin America?

Successful partnerships between researchers and local healthcare providers are crucial for the success of medical studies in Latin America, as they enhance collaboration and facilitate recruitment.

What are some successful examples of clinical trials in Latin America?

Successful examples include the partnership between Greenlight Guru and bioaccess™, which expedited Medtech innovations, and Flow-FX’s first-in-human study in Colombia, demonstrating effective strategies in clinical trials.

How does INVIMA contribute to clinical trials in Colombia?

INVIMA, Colombia’s National Food and Drug Surveillance Institute, oversees research studies, ensuring adherence to national standards and facilitating the importation of investigational devices.

What is expected for the future of clinical trials in Latin America?

The clinical trial hotspots in Latin America are anticipated to experience significant growth, especially in Phase III studies, driven by the expansion of Contract Research Organizations (CROs) and improved patient-physician relationships.

List of Sources
1. The Rise of Latin America as a Clinical Trial Destination
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  - Latin America Clinical Trials Market Size & Outlook, 2033 (https://grandviewresearch.com/horizon/outlook/clinical-trials-market/latin-america)
2. Identifying Key Hotspots for Clinical Trials in Latin America
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  - Latin America Clinical Trials Market Size & Outlook, 2033 (https://grandviewresearch.com/horizon/outlook/clinical-trials-market/latin-america)
3. Navigating Regulatory Challenges in Latin American Clinical Trials
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  - Latin America: A Compelling Region To Conduct Your Clinical Trials (https://clinicalleader.com/doc/latin-america-a-compelling-region-to-conduct-your-clinical-trials-0001)
4. Leveraging Technology for Enhanced Clinical Trial Efficiency
  - Using digital technologies in clinical trials: current and future applications – PMC (https://pmc.ncbi.nlm.nih.gov/articles/PMC8734581)
  - nature.com (https://nature.com/articles/s41746-020-0302-y)
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5. Ensuring Equitable Access to Clinical Trials in Latin America
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  - Latin America Clinical Trials Market Size & Outlook, 2033 (https://grandviewresearch.com/horizon/outlook/clinical-trials-market/latin-america)
June 26, 2026
Navigate Ethics Committee Approval For Clinical Trials In Brazil

<h2 id="introduction">Introduction</h2>

<p>Understanding the pivotal role of ethics committees is essential for successfully navigating clinical trials in Brazil. This guide outlines the essential steps for obtaining ethics committee approval and highlights recent legislative changes that enhance trial initiation efficiency.</p>

<p>However, researchers often face significant challenges, including:</p>

<ul>

<li>Lengthy approval timelines</li>

<li>Complex documentation requirements</li>

</ul>

<p>What strategies can sponsors employ to overcome these hurdles and ensure their clinical studies launch on time? These challenges can lead to delays that jeopardize the entire research timeline. Addressing these challenges head-on is crucial for ensuring timely and successful clinical study launches.</p>

<h2 id="understand-the-role-of-ethics-committees-in-clinical-trials">Understand the Role of Ethics Committees in Clinical Trials</h2>

<p>Navigating the complexities of clinical research in Brazil hinges on understanding the pivotal role of <a href="https://bioaccessla.com/news/axoft-receives-ethics-committee-approval-for-first-in-human-clinical-trial-in-panama">ethics committee approval</a> for conducting a <a href="https://bioaccessla.com/br/contact-us">clinical trial</a>, which is essential for safeguarding participant welfare and ensuring compliance with ethical standards. Let’s explore their key functions:</p>

<ol>

<li>Protocol Review: Ethics committees meticulously evaluate research protocols to confirm that study designs are ethical and that risks to participants are minimized. This assessment is essential for ensuring participant safety and confirming that the study is scientifically sound.</li>

<li>Informed Consent: They assess <a href="https://tfscro.com/resources/the-role-of-ethics-committees-in-clinical-trials-ensuring-patient-safety" rel="noopener noreferrer nofollow" target="_blank">informed consent documents</a> to guarantee that participants are fully informed about the study, including potential risks and benefits. This process is vital for upholding the autonomy and rights of participants.</li>

<li>Continuous Oversight: Throughout the study, review boards provide ongoing supervision to ensure adherence to standards and to address any adverse events that may occur. This ongoing monitoring is essential for maintaining the integrity of the research.</li>

<li><a href="https://tfscro.com/resources/the-role-of-ethics-committees-in-clinical-trials-ensuring-patient-safety" rel="noopener noreferrer nofollow" target="_blank">Authorization Process</a>: Before a clinical study can begin, it must obtain ethics committee approval for the Brazil clinical trial, which is a prerequisite for submission to ANVISA (Agência Nacional de Vigilância Sanitária). The ethical review must be finalized within 30 business days from the acceptance of all research documents, significantly affecting the overall timeline for study initiation. If additional information is required, delays in the authorization process can hinder timely study initiation, impacting research outcomes.</li>

</ol>

<p>Comprehending these roles is essential for navigating the authorization process efficiently, especially for <a href="https://bioaccessla.com/br/services">first-in-human studies</a> where ethical concerns are critical. With the <a href="https://psi-cro.com/brazil-new-clinical-research-law" rel="noopener noreferrer nofollow" target="_blank">new law</a>, researchers can expect a more streamlined authorization process, allowing for quicker study launches. As the landscape evolves with new regulations, staying informed about these changes will be crucial for researchers aiming to expedite their studies while upholding ethical integrity.</p>

<p><img alt="This mindmap illustrates the essential roles of ethics committees in clinical trials. Start at the center with the main role, then follow the branches to see each specific function and its importance in ensuring ethical standards and participant safety." src="https://images.tely.ai/telyai/eyvmppxa-this-mindmap-illustrates-the-essential-roles-of-ethics-committees-in-clinical-trials-start-at-the-center-with-the-main-role-then-follow-the-branches-to-see-each-specific-function-and-its-importance-in-ensuring-ethical-standards-and-participant-safety.webp" title="This mindmap illustrates the essential roles of ethics committees in clinical trials. Start at the center with the main role, then follow the branches to see each specific function and its importance in ensuring ethical standards and participant safety."/></p>

<h2 id="review-brazils-regulatory-framework-for-ethics-approval">Review Brazil's Regulatory Framework for Ethics Approval</h2>

<p>Navigating Brazil's evolving regulatory landscape for clinical research sponsors involves obtaining <a href="https://bioaccessla.com/es/services">ethics committee approval for clinical trials</a>, presenting both challenges and opportunities. The regulatory framework for studies is primarily overseen by ANVISA and the <a href="https://lickslegal.com/post/new-regulations-for-clinical-research-in-brazil" rel="noopener noreferrer nofollow" target="_blank">newly formed National Ethics Committee (INAEP)</a>, which is essential for obtaining ethics committee approval for <a href="https://bioaccessla.com/latin-america-medtech-research-site-search-and-selection">Brazil clinical trials</a>. Here are the key components of this framework:</p>

<ol>

<li>ANVISA Submission: All <a href="https://bioaccessla.com/services">clinical trials must be submitted to ANVISA</a> for evaluation. The review process is limited to 90 business days, greatly improving the pace of authorizations compared to prior timelines.</li>

<li>Under INAEP Oversight, researchers must now secure <a href="https://bioaccessla.com/blog/5-key-practices-for-patient-safety-under-cofepris-regulations">ethics committee approval in Brazil</a> for the clinical trial before submitting to ANVISA. This ensures that <a href="https://bioaccessla.com/blog/4-best-practices-for-fda-guidance-validation-in-clinical-research">ethical standards are upheld</a> throughout the research process, including the requirement for ethics committee approval for the Brazil clinical trial, with INAEP supervising local committees to maintain consistency.</li>

<li><a href="https://bioaccessla.com/blog/10-serbian-sop-templates-for-streamlined-trial-compliance">Plataforma Brasil</a>: Researchers must register their studies on Plataforma Brasil, the national system for ethical clearance. This platform simplifies the submission process and enables tracking of endorsements, enhancing communication among stakeholders.</li>

<li>New Regulations: As of May 2024, Brazil enacted <a href="https://clinicalleader.com/doc/how-brazil-s-new-law-is-redefining-the-country-s-clinical-research-0001" rel="noopener noreferrer nofollow" target="_blank">Law No. 14.874</a>, which streamlines the process by permitting simultaneous submissions to ANVISA and review boards. This regulatory flexibility is anticipated to encourage innovation and enhance Brazil's competitiveness in the global research landscape.</li>

</ol>

<p>Understanding this regulatory framework is crucial for sponsors who want to effectively navigate the complexities of ethical consent and obtain ethics committee approval for a clinical trial in Brazil. These changes position Brazil as a more attractive destination for innovative clinical research, fostering growth in the Medtech sector.</p>

<p><img alt="This flowchart outlines the steps needed to obtain ethics committee approval for clinical trials in Brazil. Each box represents a key step in the process, and the arrows show the order in which these steps should be completed. Follow the flow to understand how to navigate the regulatory landscape effectively." src="https://images.tely.ai/telyai/dwholqnu-this-flowchart-outlines-the-steps-needed-to-obtain-ethics-committee-approval-for-clinical-trials-in-brazil-each-box-represents-a-key-step-in-the-process-and-the-arrows-show-the-order-in-which-these-steps-should-be-completed-follow-the-flow-to-understand-how-to-navigate-the-regulatory-landscape-effectively.webp" title="This flowchart outlines the steps needed to obtain ethics committee approval for clinical trials in Brazil. Each box represents a key step in the process, and the arrows show the order in which these steps should be completed. Follow the flow to understand how to navigate the regulatory landscape effectively."/></p>

<h2 id="prepare-and-submit-required-documentation-for-approval">Prepare and Submit Required Documentation for Approval</h2>

<p>Gaining <a href="https://bioaccessla.com/market-access">ethics committee approval</a> for a clinical trial in Brazil is a critical yet intricate process that demands meticulous attention to detail. To navigate this landscape effectively, sponsors must prepare and submit a comprehensive set of documents. Here’s a step-by-step guide:</p>

<ol>

<li>

<p>Compile <a href="https://bioaccessla.com/blog/10-essential-edc-software-features-for-clinical-research-directors">Essential Documents</a>: The following documents are typically required:</p>

<ul>

<li>Research protocol</li>

<li>Informed consent forms</li>

<li>Investigator's brochure</li>

<li>Case report forms (CRFs)</li>

<li>Ethics committee approval from the local CEP</li>

<li>Any previous approvals or correspondence with <a href="https://bioaccessla.com/resources">regulatory bodies</a></li>

</ul>

</li>

<li>

<p>Register on <a href="https://bioaccessla.com/blog/10-key-regulatory-considerations-for-rare-disease-trials-in-romania">Plataforma Brasil</a>: Create an account on Plataforma Brasil, the national registry for clinical research, and register your study. Ensure that all required documents are uploaded in the correct format, including electronic copies with text searching capability.</p>

</li>

<li>

<p>Submit to Local CEP: Once registered, submit your application to the <a href="https://bioaccessla.com/blog/10-steps-for-effective-ec-ce-compliance-in-medical-devices">local committee</a> for review. This submission must include all necessary documentation and a cover letter outlining the study's objectives and significance. The CEP will review the protocol documentation for completeness within 10 days of submission and issue an initial report within 30 days after full acceptance of the protocol documents.</p>

</li>

<li>

<p>Follow Up: After submission, staying in touch with the review board can really help make the review process smoother. Address any questions or requests for additional information promptly to facilitate a more efficient review.</p>

</li>

<li>

<p>Prepare for <a href="https://globalregulatorypartners.com/clinical-trials-for-drugs-medicines-in-brazil-and-the-clinical-trial-application-process" rel="noopener noreferrer nofollow" target="_blank">ANVISA Submission</a>: Once you obtain consent from the local CEP, prepare your submission for ANVISA. You need to ensure that all documents meet their criteria. This includes proof of the ethics committee approval for the Brazil clinical trial and a detailed research protocol. ANVISA generally requires 90 calendar days to assess the application, and if no feedback is provided within this period, development can proceed, assuming ethical permissions are in place.</p>

</li>

</ol>

<p>Ultimately, a well-prepared submission can significantly streamline the path to successful <a href="https://bioaccessla.com/br/about">clinical trials in Brazil</a>.</p>

<p><img alt="This flowchart shows the steps you need to take to get approval for a clinical trial in Brazil. Start at the top and follow the arrows down to see what you need to do at each stage, including what documents to prepare and where to submit them." src="https://images.tely.ai/telyai/lmoybooh-this-flowchart-shows-the-steps-you-need-to-take-to-get-approval-for-a-clinical-trial-in-brazil-start-at-the-top-and-follow-the-arrows-down-to-see-what-you-need-to-do-at-each-stage-including-what-documents-to-prepare-and-where-to-submit-them.webp" title="This flowchart shows the steps you need to take to get approval for a clinical trial in Brazil. Start at the top and follow the arrows down to see what you need to do at each stage, including what documents to prepare and where to submit them."/></p>

<h2 id="identify-and-overcome-common-challenges-in-the-approval-process">Identify and Overcome Common Challenges in the Approval Process</h2>

<p>Navigating the review process for research in Brazil can present several challenges that may impede <a href="https://bioaccessla.com/br/news">timely progress</a>. Here are some common obstacles and strategies to overcome them:</p>

<ol>

<li><a href="https://bioaccessla.com/blog/10-essential-steps-of-randomised-control-trial-for-clinical-success">Lengthy Approval Times</a>: Authorization from review boards can take longer than anticipated, often surpassing 180 days under the previous system. Recent <a href="https://bioaccessla.com/solutions">regulatory changes</a> now allow for a maximum approval time of just 30 days for standard submissions, and even less for strategic research. To mitigate delays, submit your application well in advance and ensure that all documentation is complete and accurate.</li>

<li><a href="https://bioaccessla.com/blog/10-croatia-ethics-committee-so-ps-every-sponsor-must-know">Incomplete Documentation</a>: One of the most common reasons for delays is incomplete submissions. Statistics show that incomplete documentation is a significant factor in delays of authorization. Make sure to use a comprehensive checklist to confirm that all required documents, including Informed Consent Forms (ICFs) and study protocols, are included before submission.</li>

<li><a href="https://bioaccessla.com/blog/7-strategies-to-enhance-diversity-in-clinical-trials">Communication Gaps</a>: Maintain open lines of communication with the compliance committee. Regularly follow up on the status of your application and be responsive to any requests for additional information. This proactive approach can help clarify any uncertainties and expedite the review process.</li>

<li>Regulatory Changes: Stay informed about changes in regulations, such as the recent enactment of <a href="https://ibanet.org/Brazil-enacts-new-law-to-regulate-clinical-trials" rel="noopener noreferrer nofollow" target="_blank">Law No. 14,874/2024 and Executive Order #12,651/2025</a>, which simplify the process for obtaining consent. Subscribe to updates from ANVISA and the National Research Ethics Board (INEP) to remain compliant and aware of any new requirements.</li>

<li>Cultural Differences: Grasping the local context and cultural subtleties can enable smoother interactions with review committees. Engaging local experts or consultants who are familiar with the Brazilian regulatory landscape can provide valuable insights and enhance communication.</li>

</ol>

<p>Addressing these challenges not only streamlines the approval process but also positions sponsors for success in bringing innovative therapies to market.</p>

<p><img alt="Each box represents a challenge faced during the approval process, and the arrows lead to strategies that can help overcome these challenges. Follow the flow to see how to tackle each obstacle effectively." src="https://images.tely.ai/telyai/ijcsaudr-each-box-represents-a-challenge-faced-during-the-approval-process-and-the-arrows-lead-to-strategies-that-can-help-overcome-these-challenges-follow-the-flow-to-see-how-to-tackle-each-obstacle-effectively.webp" title="Each box represents a challenge faced during the approval process, and the arrows lead to strategies that can help overcome these challenges. Follow the flow to see how to tackle each obstacle effectively."/></p>

<h2 id="conclusion">Conclusion</h2>

<p>The ethics committee approval process in Brazil presents both challenges and opportunities for clinical trial researchers. Researchers must grasp the vital roles of ethics committees, which range from reviewing protocols to providing ongoing oversight. The recent regulatory changes have streamlined this process, offering a clearer path for obtaining necessary approvals.</p>

<p>This article highlights key components of Brazil's regulatory framework, including the importance of ANVISA submissions and the need for registering on Plataforma Brasil. Navigating the registration process on Plataforma Brasil can be daunting for many researchers. Additionally, the new law facilitates simultaneous submissions, simplifying the process and accelerating the timeline for research initiatives. Comprehensive documentation and proactive communication with ethics committees are essential to overcoming common challenges, such as lengthy approval times and incomplete submissions.</p>

<p>Ultimately, the significance of ethics committee approval extends beyond compliance; it fosters a culture of safety and respect for participants in clinical trials. By understanding and addressing the challenges outlined, researchers can enhance their chances of success in bringing innovative therapies to market. Engaging with local experts and staying informed about regulatory changes will not only expedite the approval process but also position Brazil as a competitive player in the global clinical research landscape. By mastering these processes, researchers can not only ensure compliance but also contribute to the advancement of medical science in Brazil.</p>

<p><iframe frameborder="0" height="300px" loading="lazy" src="https://iframe.tely.ai/cta/eyJhcnRpY2xlX2lkIjogIjY5ZjUzZWY4ODdhNmQ3Y2IxOTU5MjYyZCIsICJjb21wYW55X2lkIjogIjY2OTk4NmYwMzM1YWQwNDI3ZTVmNTdlMyIsICJpbmRleCI6IG51bGwsICJ0eXBlIjogImFydGljbGUifQ==" width="100%"></iframe></p>

<h2 id="frequently-asked-questions">Frequently Asked Questions</h2>

<p><strong>What is the role of ethics committees in clinical trials in Brazil?</strong></p>

<p>Ethics committees play a crucial role in clinical trials in Brazil by reviewing research protocols to ensure they are ethical, assessing informed consent documents to protect participant rights, providing continuous oversight during the study, and approving studies before they can begin.</p>

<p><strong>How do ethics committees evaluate research protocols?</strong></p>

<p>Ethics committees meticulously evaluate research protocols to confirm that study designs are ethical and that risks to participants are minimized, ensuring participant safety and scientific soundness.</p>

<p><strong>What is the importance of informed consent in clinical trials?</strong></p>

<p>Informed consent is vital as ethics committees assess the consent documents to ensure participants are fully informed about the study, including potential risks and benefits, thereby upholding their autonomy and rights.</p>

<p><strong>What kind of oversight do ethics committees provide during a clinical study?</strong></p>

<p>Ethics committees provide ongoing supervision throughout the study to ensure adherence to ethical standards and to address any adverse events that may occur, maintaining the integrity of the research.</p>

<p><strong>What is the authorization process for a clinical study in Brazil?</strong></p>

<p>Before a clinical study can commence, it must obtain ethics committee approval, which is a prerequisite for submission to ANVISA. The ethical review must be finalized within 30 business days from the acceptance of all research documents.</p>

<p><strong>How can delays in the authorization process impact clinical trials?</strong></p>

<p>If additional information is required during the ethics committee review, it can delay the authorization process, hindering timely study initiation and potentially impacting research outcomes.</p>

<p><strong>What recent changes have been made to the authorization process for clinical trials?</strong></p>

<p>Recent changes in the law have led to a more streamlined authorization process, allowing for quicker study launches, which is particularly beneficial for first-in-human studies where ethical concerns are critical.</p>

<p><strong>Why is it important for researchers to stay informed about changes in regulations?</strong></p>

<p>Staying informed about evolving regulations is crucial for researchers aiming to expedite their studies while maintaining ethical integrity, especially in the context of first-in-human and early feasibility clinical trials.</p>

<h2 id="list-of-sources">List of Sources</h2>

<ol>

<li>Understand the Role of Ethics Committees in Clinical Trials

<ul>

<li>What to Know About Brazil’s New Clinical Research Law (https://psi-cro.com/brazil-new-clinical-research-law)</li>

<li>Avaliação de ensaios clínicos no Brasil: histórico e atualidades (https://scielo.br/j/bioet/a/Bhk4bDL8wYTZtPc6PrpWycQ?format=pdf&lang=en)</li>

<li>The Role of Ethics Committees in Clinical Trials – TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO (https://tfscro.com/resources/the-role-of-ethics-committees-in-clinical-trials-ensuring-patient-safety)</li>

<li>7 essential roles of ethics committee in clinical trials (https://pharmaeducenter.com/blog/role-of-ethics-committee-in-clinical-trials)</li>

</ul>

</li>

<li>Review Brazil's Regulatory Framework for Ethics Approval

<ul>

<li>Brazil Just Changed The Rules For Clinical Trial Approvals — What Sponsors Need To Know | bioaccess® (https://bioaccessla.com/blog/brazil-anvisa-parallel-review-clinical-trial-approvals-2026)</li>

<li>New regulations for clinical research in Brazil | Licks Attorneys (https://lickslegal.com/post/new-regulations-for-clinical-research-in-brazil)</li>

<li>Brazil Cuts Clinical Trial Approval Timeline to 90 Days | bioaccess®: Fast-Tracking First-in-Human Trials, Anywhere posted on the topic | LinkedIn (https://linkedin.com/posts/bioaccess_clinicaltrials-brazil-anvisa-activity-7447976698958106627-98MW)</li>

<li>How Brazil's New Law Is Redefining The Country's Clinical Research (https://clinicalleader.com/doc/how-brazil-s-new-law-is-redefining-the-country-s-clinical-research-0001)</li>

</ul>

</li>

<li>Prepare and Submit Required Documentation for Approval

<ul>

<li>Clinical Trial Regulatory Process – Brazil | Credevo Articles (https://credevo.com/articles/2019/03/14/clinical-trial-regulatory-process-brazil)</li>

<li>Clinical Trials for Drugs/Medicines in Brazil and the Clinical Trial Application process (https://globalregulatorypartners.com/clinical-trials-for-drugs-medicines-in-brazil-and-the-clinical-trial-application-process)</li>

</ul>

</li>

<li>Identify and Overcome Common Challenges in the Approval Process

<ul>

<li>New regulations for clinical research in Brazil | Licks Attorneys (https://lickslegal.com/post/new-regulations-for-clinical-research-in-brazil)</li>

<li>Brazil enacts a law to regulate clinical trials (https://ibanet.org/Brazil-enacts-new-law-to-regulate-clinical-trials)</li>

<li>Best Practices For First-In-Human Clinical Trials In Brazil | bioaccess® (https://bioaccessla.com/blog/best-practices-for-first-in-human-clinical-trials-in-brazil)</li>

<li>Understanding Ethics Committee Considerations … | bioaccess® (https://bioaccessla.com/blog/understanding-ethics-committee-considerations-in-brazil-a-comprehensive-tutorial)</li>

</ul>

</li>

</ol>

<script type="application/ld+json">{"@context": "https://schema.org", "@type": "FAQPage", "mainEntity": [{"@type": "Question", "name": "What is the role of ethics committees in clinical trials in Brazil?", "acceptedAnswer": {"@type": "Answer", "text": "Ethics committees play a crucial role in clinical trials in Brazil by reviewing research protocols to ensure they are ethical, assessing informed consent documents to protect participant rights, providing continuous oversight during the study, and approving studies before they can begin."}}, {"@type": "Question", "name": "How do ethics committees evaluate research protocols?", "acceptedAnswer": {"@type": "Answer", "text": "Ethics committees meticulously evaluate research protocols to confirm that study designs are ethical and that risks to participants are minimized, ensuring participant safety and scientific soundness."}}, {"@type": "Question", "name": "What is the importance of informed consent in clinical trials?", "acceptedAnswer": {"@type": "Answer", "text": "Informed consent is vital as ethics committees assess the consent documents to ensure participants are fully informed about the study, including potential risks and benefits, thereby upholding their autonomy and rights."}}, {"@type": "Question", "name": "What kind of oversight do ethics committees provide during a clinical study?", "acceptedAnswer": {"@type": "Answer", "text": "Ethics committees provide ongoing supervision throughout the study to ensure adherence to ethical standards and to address any adverse events that may occur, maintaining the integrity of the research."}}, {"@type": "Question", "name": "What is the authorization process for a clinical study in Brazil?", "acceptedAnswer": {"@type": "Answer", "text": "Before a clinical study can commence, it must obtain ethics committee approval, which is a prerequisite for submission to ANVISA. The ethical review must be finalized within 30 business days from the acceptance of all research documents."}}, {"@type": "Question", "name": "How can delays in the authorization process impact clinical trials?", "acceptedAnswer": {"@type": "Answer", "text": "If additional information is required during the ethics committee review, it can delay the authorization process, hindering timely study initiation and potentially impacting research outcomes."}}, {"@type": "Question", "name": "What recent changes have been made to the authorization process for clinical trials?", "acceptedAnswer": {"@type": "Answer", "text": "Recent changes in the law have led to a more streamlined authorization process, allowing for quicker study launches, which is particularly beneficial for first-in-human studies where ethical concerns are critical."}}, {"@type": "Question", "name": "Why is it important for researchers to stay informed about changes in regulations?", "acceptedAnswer": {"@type": "Answer", "text": "Staying informed about evolving regulations is crucial for researchers aiming to expedite their studies while maintaining ethical integrity, especially in the context of first-in-human and early feasibility clinical trials."}}]}</script><script type="application/ld+json">{"@context": "https://schema.org", "@type": "BlogPosting", "headline": "Navigate Ethics Committee Approval for Clinical Trials in Brazil", "description": "Navigate the ethics committee approval process for clinical trials in Brazil efficiently and successfully.", "datePublished": "2026-05-02T00:02:00.602000", "dateModified": "2026-05-02T04:47:39.578139+00:00", "articleBody": "## IntroductionnUnderstanding the pivotal role of ethics committees is essential for successfully navigating clinical trials in Brazil. This guide outlines the essential steps for obtaining ethics committee approval and highlights recent legislative changes that enhance trial initiation efficiency. nnHowever, researchers often face significant challenges, including:nn- Lengthy approval timelinesn- Complex documentation requirementsnnWhat strategies can sponsors employ to overcome these hurdles and ensure their clinical studies launch on time? These challenges can lead to delays that jeopardize the entire research timeline. Addressing these challenges head-on is crucial for ensuring timely and successful clinical study launches.nn## Understand the Role of Ethics Committees in Clinical TrialsnnNavigating the complexities of clinical research in Brazil hinges on understanding the pivotal role of [ethics committee approval](https://bioaccessla.com/news/axoft-receives-ethics-committee-approval-for-first-in-human-clinical-trial-in-panama) for conducting a [clinical trial](https://bioaccessla.com/br/contact-us), which is essential for safeguarding participant welfare and ensuring compliance with ethical standards. Let’s explore their key functions:nn1. Protocol Review: Ethics committees meticulously evaluate research protocols to confirm that study designs are ethical and that risks to participants are minimized. This assessment is essential for ensuring participant safety and confirming that the study is scientifically sound.n2. Informed Consent: They assess [informed consent documents](https://tfscro.com/resources/the-role-of-ethics-committees-in-clinical-trials-ensuring-patient-safety) to guarantee that participants are fully informed about the study, including potential risks and benefits. This process is vital for upholding the autonomy and rights of participants.n3. Continuous Oversight: Throughout the study, review boards provide ongoing supervision to ensure adherence to standards and to address any adverse events that may occur. This ongoing monitoring is essential for maintaining the integrity of the research.n4. [Authorization Process](https://tfscro.com/resources/the-role-of-ethics-committees-in-clinical-trials-ensuring-patient-safety): Before a clinical study can begin, it must obtain ethics committee approval for the Brazil clinical trial, which is a prerequisite for submission to ANVISA (Agência Nacional de Vigilância Sanitária). The ethical review must be finalized within 30 business days from the acceptance of all research documents, significantly affecting the overall timeline for study initiation. If additional information is required, delays in the authorization process can hinder timely study initiation, impacting research outcomes.nnComprehending these roles is essential for navigating the authorization process efficiently, especially for [first-in-human studies](https://bioaccessla.com/br/services) where ethical concerns are critical. With the [new law](https://psi-cro.com/brazil-new-clinical-research-law), researchers can expect a more streamlined authorization process, allowing for quicker study launches. As the landscape evolves with new regulations, staying informed about these changes will be crucial for researchers aiming to expedite their studies while upholding ethical integrity.nn![This mindmap illustrates the essential roles of ethics committees in clinical trials. Start at the center with the main role, then follow the branches to see each specific function and its importance in ensuring ethical standards and participant safety.](https://images.tely.ai/telyai/eyvmppxa-this-mindmap-illustrates-the-essential-roles-of-ethics-committees-in-clinical-trials-start-at-the-center-with-the-main-role-then-follow-the-branches-to-see-each-specific-function-and-its-importance-in-ensuring-ethical-standards-and-participant-safety.webp "This mindmap illustrates the essential roles of ethics committees in clinical trials. Start at the center with the main role, then follow the branches to see each specific function and its importance in ensuring ethical standards and participant safety.")nn## Review Brazil's Regulatory Framework for Ethics ApprovalnnNavigating Brazil's evolving regulatory landscape for clinical research sponsors involves obtaining [ethics committee approval for clinical trials](https://bioaccessla.com/es/services), presenting both challenges and opportunities. The regulatory framework for studies is primarily overseen by ANVISA and the [newly formed National Ethics Committee (INAEP)](https://lickslegal.com/post/new-regulations-for-clinical-research-in-brazil), which is essential for obtaining ethics committee approval for [Brazil clinical trials](https://bioaccessla.com/latin-america-medtech-research-site-search-and-selection). Here are the key components of this framework:nn1. ANVISA Submission: All [clinical trials must be submitted to ANVISA](https://bioaccessla.com/services) for evaluation. The review process is limited to 90 business days, greatly improving the pace of authorizations compared to prior timelines.n2. Under INAEP Oversight, researchers must now secure [ethics committee approval in Brazil](https://bioaccessla.com/blog/5-key-practices-for-patient-safety-under-cofepris-regulations) for the clinical trial before submitting to ANVISA. This ensures that [ethical standards are upheld](https://bioaccessla.com/blog/4-best-practices-for-fda-guidance-validation-in-clinical-research) throughout the research process, including the requirement for ethics committee approval for the Brazil clinical trial, with INAEP supervising local committees to maintain consistency.n3. [Plataforma Brasil](https://bioaccessla.com/blog/10-serbian-sop-templates-for-streamlined-trial-compliance): Researchers must register their studies on Plataforma Brasil, the national system for ethical clearance. This platform simplifies the submission process and enables tracking of endorsements, enhancing communication among stakeholders.n4. New Regulations: As of May 2024, Brazil enacted [Law No. 14.874](https://clinicalleader.com/doc/how-brazil-s-new-law-is-redefining-the-country-s-clinical-research-0001), which streamlines the process by permitting simultaneous submissions to ANVISA and review boards. This regulatory flexibility is anticipated to encourage innovation and enhance Brazil's competitiveness in the global research landscape.nnUnderstanding this regulatory framework is crucial for sponsors who want to effectively navigate the complexities of ethical consent and obtain ethics committee approval for a clinical trial in Brazil. These changes position Brazil as a more attractive destination for innovative clinical research, fostering growth in the Medtech sector.nn![This flowchart outlines the steps needed to obtain ethics committee approval for clinical trials in Brazil. Each box represents a key step in the process, and the arrows show the order in which these steps should be completed. Follow the flow to understand how to navigate the regulatory landscape effectively.](https://images.tely.ai/telyai/dwholqnu-this-flowchart-outlines-the-steps-needed-to-obtain-ethics-committee-approval-for-clinical-trials-in-brazil-each-box-represents-a-key-step-in-the-process-and-the-arrows-show-the-order-in-which-these-steps-should-be-completed-follow-the-flow-to-understand-how-to-navigate-the-regulatory-landscape-effectively.webp "This flowchart outlines the steps needed to obtain ethics committee approval for clinical trials in Brazil. Each box represents a key step in the process, and the arrows show the order in which these steps should be completed. Follow the flow to understand how to navigate the regulatory landscape effectively.")nn## Prepare and Submit Required Documentation for ApprovalnnGaining [ethics committee approval](https://bioaccessla.com/market-access) for a clinical trial in Brazil is a critical yet intricate process that demands meticulous attention to detail. To navigate this landscape effectively, sponsors must prepare and submit a comprehensive set of documents. Here’s a step-by-step guide:nn1. Compile [Essential Documents](https://bioaccessla.com/blog/10-essential-edc-software-features-for-clinical-research-directors): The following documents are typically required:nn – Research protocoln – Informed consent formsn – Investigator's brochuren – Case report forms (CRFs)n – Ethics committee approval from the local CEPn – Any previous approvals or correspondence with [regulatory bodies](https://bioaccessla.com/resources)n2. Register on [Plataforma Brasil](https://bioaccessla.com/blog/10-key-regulatory-considerations-for-rare-disease-trials-in-romania): Create an account on Plataforma Brasil, the national registry for clinical research, and register your study. Ensure that all required documents are uploaded in the correct format, including electronic copies with text searching capability.n3. Submit to Local CEP: Once registered, submit your application to the [local committee](https://bioaccessla.com/blog/10-steps-for-effective-ec-ce-compliance-in-medical-devices) for review. This submission must include all necessary documentation and a cover letter outlining the study's objectives and significance. The CEP will review the protocol documentation for completeness within 10 days of submission and issue an initial report within 30 days after full acceptance of the protocol documents.n4. Follow Up: After submission, staying in touch with the review board can really help make the review process smoother. Address any questions or requests for additional information promptly to facilitate a more efficient review.n5. Prepare for [ANVISA Submission](https://globalregulatorypartners.com/clinical-trials-for-drugs-medicines-in-brazil-and-the-clinical-trial-application-process): Once you obtain consent from the local CEP, prepare your submission for ANVISA. You need to ensure that all documents meet their criteria. This includes proof of the ethics committee approval for the Brazil clinical trial and a detailed research protocol. ANVISA generally requires 90 calendar days to assess the application, and if no feedback is provided within this period, development can proceed, assuming ethical permissions are in place.nnUltimately, a well-prepared submission can significantly streamline the path to successful [clinical trials in Brazil](https://bioaccessla.com/br/about).nn![This flowchart shows the steps you need to take to get approval for a clinical trial in Brazil. Start at the top and follow the arrows down to see what you need to do at each stage, including what documents to prepare and where to submit them.](https://images.tely.ai/telyai/lmoybooh-this-flowchart-shows-the-steps-you-need-to-take-to-get-approval-for-a-clinical-trial-in-brazil-start-at-the-top-and-follow-the-arrows-down-to-see-what-you-need-to-do-at-each-stage-including-what-documents-to-prepare-and-where-to-submit-them.webp "This flowchart shows the steps you need to take to get approval for a clinical trial in Brazil. Start at the top and follow the arrows down to see what you need to do at each stage, including what documents to prepare and where to submit them.")nn## Identify and Overcome Common Challenges in the Approval ProcessnnNavigating the review process for research in Brazil can present several challenges that may impede [timely progress](https://bioaccessla.com/br/news). Here are some common obstacles and strategies to overcome them:nn1. [Lengthy Approval Times](https://bioaccessla.com/blog/10-essential-steps-of-randomised-control-trial-for-clinical-success): Authorization from review boards can take longer than anticipated, often surpassing 180 days under the previous system. Recent [regulatory changes](https://bioaccessla.com/solutions) now allow for a maximum approval time of just 30 days for standard submissions, and even less for strategic research. To mitigate delays, submit your application well in advance and ensure that all documentation is complete and accurate.n2. [Incomplete Documentation](https://bioaccessla.com/blog/10-croatia-ethics-committee-so-ps-every-sponsor-must-know): One of the most common reasons for delays is incomplete submissions. Statistics show that incomplete documentation is a significant factor in delays of authorization. Make sure to use a comprehensive checklist to confirm that all required documents, including Informed Consent Forms (ICFs) and study protocols, are included before submission.n3. [Communication Gaps](https://bioaccessla.com/blog/7-strategies-to-enhance-diversity-in-clinical-trials): Maintain open lines of communication with the compliance committee. Regularly follow up on the status of your application and be responsive to any requests for additional information. This proactive approach can help clarify any uncertainties and expedite the review process.n4. Regulatory Changes: Stay informed about changes in regulations, such as the recent enactment of [Law No. 14,874/2024 and Executive Order #12,651/2025](https://ibanet.org/Brazil-enacts-new-law-to-regulate-clinical-trials), which simplify the process for obtaining consent. Subscribe to updates from ANVISA and the National Research Ethics Board (INEP) to remain compliant and aware of any new requirements.n5. Cultural Differences: Grasping the local context and cultural subtleties can enable smoother interactions with review committees. Engaging local experts or consultants who are familiar with the Brazilian regulatory landscape can provide valuable insights and enhance communication.nnAddressing these challenges not only streamlines the approval process but also positions sponsors for success in bringing innovative therapies to market.nn![Each box represents a challenge faced during the approval process, and the arrows lead to strategies that can help overcome these challenges. Follow the flow to see how to tackle each obstacle effectively.](https://images.tely.ai/telyai/ijcsaudr-each-box-represents-a-challenge-faced-during-the-approval-process-and-the-arrows-lead-to-strategies-that-can-help-overcome-these-challenges-follow-the-flow-to-see-how-to-tackle-each-obstacle-effectively.webp "Each box represents a challenge faced during the approval process, and the arrows lead to strategies that can help overcome these challenges. Follow the flow to see how to tackle each obstacle effectively.")nn## ConclusionnThe ethics committee approval process in Brazil presents both challenges and opportunities for clinical trial researchers. Researchers must grasp the vital roles of ethics committees, which range from reviewing protocols to providing ongoing oversight. The recent regulatory changes have streamlined this process, offering a clearer path for obtaining necessary approvals. nnThis article highlights key components of Brazil's regulatory framework, including the importance of ANVISA submissions and the need for registering on Plataforma Brasil. Navigating the registration process on Plataforma Brasil can be daunting for many researchers. Additionally, the new law facilitates simultaneous submissions, simplifying the process and accelerating the timeline for research initiatives. Comprehensive documentation and proactive communication with ethics committees are essential to overcoming common challenges, such as lengthy approval times and incomplete submissions. nnUltimately, the significance of ethics committee approval extends beyond compliance; it fosters a culture of safety and respect for participants in clinical trials. By understanding and addressing the challenges outlined, researchers can enhance their chances of success in bringing innovative therapies to market. Engaging with local experts and staying informed about regulatory changes will not only expedite the approval process but also position Brazil as a competitive player in the global clinical research landscape. By mastering these processes, researchers can not only ensure compliance but also contribute to the advancement of medical science in Brazil.nn::iframe[https://iframe.tely.ai/cta/eyJhcnRpY2xlX2lkIjogIjY5ZjUzZWY4ODdhNmQ3Y2IxOTU5MjYyZCIsICJjb21wYW55X2lkIjogIjY2OTk4NmYwMzM1YWQwNDI3ZTVmNTdlMyIsICJpbmRleCI6IG51bGwsICJ0eXBlIjogImFydGljbGUifQ==]{width="100%" height="300px"}", "image": ["https://images.tely.ai/telyai/eyvmppxa-this-mindmap-illustrates-the-essential-roles-of-ethics-committees-in-clinical-trials-start-at-the-center-with-the-main-role-then-follow-the-branches-to-see-each-specific-function-and-its-importance-in-ensuring-ethical-standards-and-participant-safety.webp", "https://images.tely.ai/telyai/dwholqnu-this-flowchart-outlines-the-steps-needed-to-obtain-ethics-committee-approval-for-clinical-trials-in-brazil-each-box-represents-a-key-step-in-the-process-and-the-arrows-show-the-order-in-which-these-steps-should-be-completed-follow-the-flow-to-understand-how-to-navigate-the-regulatory-landscape-effectively.webp", "https://images.tely.ai/telyai/lmoybooh-this-flowchart-shows-the-steps-you-need-to-take-to-get-approval-for-a-clinical-trial-in-brazil-start-at-the-top-and-follow-the-arrows-down-to-see-what-you-need-to-do-at-each-stage-including-what-documents-to-prepare-and-where-to-submit-them.webp", "https://images.tely.ai/telyai/ijcsaudr-each-box-represents-a-challenge-faced-during-the-approval-process-and-the-arrows-lead-to-strategies-that-can-help-overcome-these-challenges-follow-the-flow-to-see-how-to-tackle-each-obstacle-effectively.webp"], "inLanguage": "en", "author": {"@type": "Organization", "name": "bioaccess®"}, "publisher": {"@type": "Organization", "name": "bioaccess®", "url": "https://bioaccessla.com"}}</script>

June 25, 2026
Radiopharmaceutical Trial Logistics In Latin America: A Sponsor’s Playbook For Isotope Supply And Shipment Risk
Radiopharmaceutical Trial Logistics in Latin America: A Sponsor’s Playbook for Isotope Supply and Shipment Risk

Radiopharmaceutical trials can deliver decisive evidence quickly—but only if the isotope and drug product arrive exactly when the protocol needs them. In Latin America, sponsors often underestimate how much logistics determines whether a nuclear medicine study stays on schedule.

This playbook explains how to plan radiopharmaceutical clinical trial logistics in Latin America: how to think about isotope supply constraints, how shipment rules affect scheduling, and what operational controls reduce risk across countries and sites.

1) Why radiopharmaceutical logistics behave differently than “regular” clinical supply

Radiopharmaceutical supply chains are shaped by physics and regulation. Short half-lives compress the delivery window, and transport is governed by dangerous-goods rules that require correct classification, packaging, labeling, and documentation. Air carriers may impose stricter acceptance policies than the baseline regulations, meaning a shipment can be rejected even if it is “technically compliant.”

For sponsors, this means two things: (1) the critical path is often the shipment acceptance process, not the manufacturing step, and (2) your protocol schedule needs built-in flexibility for shipping windows.

2) Build your “isotope availability model” before you lock the protocol calendar

Before finalizing visit schedules, sponsors should map isotope availability and constraints:
- Production modality: reactor-produced vs cyclotron-produced isotopes have different outage risks and distribution footprints.
- Lane feasibility: direct flights vs multi-leg routes; the more handoffs, the higher the probability of delay.
- Site readiness: receiving procedures, radiation safety officer availability, and hot-lab capacity.
- Redundancy: secondary suppliers and alternative lanes that can be activated quickly.
In practice, the sponsor’s goal is to convert “isotope risk” into a schedule plan: identify which visits require exact timing and where windows can be widened without compromising scientific validity.

3) Shipment acceptance: treat documentation as a quality system, not paperwork

Dangerous-goods air shipment requirements are aligned to international aviation technical instructions, but real-world acceptance depends on flawless execution: correct hazard classification, compliant packaging, correct labels/markings, and validated shipping papers. Forwarders commonly perform a regulation check and documentation validation step before a carrier will accept the booking, and carriers may refuse certain dangerous goods categories or require pre-approval.

Operational best practices include:
- Standardize templates for shipping papers and site receiving logs.
- Pre-clear with carriers and confirm acceptance policies before the shipment arrives at the warehouse.
- Run a “dry run” shipment simulation (without active product) to validate lane timing, broker actions, and site receipt workflow.
- Define handoff accountability at every step: manufacturer → forwarder → airline → customs broker → site.
These controls reduce last-minute rejections and help sponsors avoid protocol deviations caused by delayed dosing or imaging windows.

4) Latin America-specific risk: cross-border variability and limited buffer time

Latin American operations add variability because requirements and infrastructure differ across countries and even across airports. Two practical implications matter most:
- Customs and clearance variability. A lane that works smoothly in one country may be unpredictable in another unless the broker has deep experience with radioactive/dangerous goods.
- Limited buffer time. Short half-lives reduce your ability to absorb delays; redundancy becomes essential (backup flight options, backup production, and backup sites).
When designing the operational plan, sponsors should assume that a percentage of shipments will be disrupted and proactively decide what happens next: reschedule patient, switch site, switch lane, or activate an alternate supplier.

FAQ
- What is the single biggest operational mistake in radiopharmaceutical trials?
  Locking a tight protocol schedule before validating the end-to-end shipment acceptance process and lane reliability.
- How do dangerous-goods rules affect clinical trial timelines?
  They introduce additional steps—classification checks, packaging/labeling verification, documentation validation, and carrier pre-approval—that can determine whether shipments move as planned.
- How can sponsors de-risk isotope supply in Latin America?
  Build redundancy (secondary suppliers and lanes), standardize documentation, pre-clear carriers, and validate site receiving readiness with a dry run.
Bottom line: Radiopharmaceutical trials in Latin America succeed when sponsors operationalize logistics as part of the study design—aligning isotope availability, carrier acceptance, and site readiness with the protocol calendar.

Sources referenced for general dangerous-goods shipment context: The overview of IATA DGR alignment to ICAO technical instructions and common shipment acceptance steps is summarized from a freight-forwarder explainer (Dimerco) and a dangerous-goods primer noting radioactive materials as Class 7 (EV Cargo).
June 24, 2026
Radiopharmaceutical Clinical Trials in Latin America: A Logistics Playbook for Isotope-Dependent Studies
Radiopharmaceutical Clinical Trials in Latin America: A Logistics Playbook for Isotope-Dependent Studies

Radiopharmaceutical clinical trials are different. Even when the science is strong and the protocol is clean, programs can fail due to a reality that traditional device or drug teams underestimate: your investigational product expires—fast. That makes logistics, importation planning, and site readiness mission-critical.

Latin America offers compelling advantages for early-stage clinical research—experienced investigators, diverse patient populations, and often faster activation pathways. But isotope-dependent studies add unique constraints across borders, airports, customs processes, and nuclear medicine infrastructure. This article provides a sponsor-oriented playbook to design a radiopharmaceutical logistics system that supports protocol execution across Latin America.

1) Start with the “half-life reality” and build the trial around it

Radiopharmaceutical programs must align manufacturing, release, transport, and administration to the isotope’s half-life and imaging or therapeutic window. The practical implication is that clinical operations should be designed from the logistics backward—not from the protocol forward.
- Define the maximum allowable time (MAT): The maximum time from end-of-synthesis to administration that still meets dose and quality criteria.
- Translate MAT into route constraints: Which airports, flight schedules, and ground transport windows can reliably meet MAT?
- Choose sites accordingly: A great investigator is not enough if a site is two unreliable connections away from the arrival airport.
2) Build a supply strategy: local production, regional hubs, or cross-border shipment

Most sponsors consider three models, sometimes combined:
- Local production: Cyclotron or generator-based production inside the country, reducing border risk.
- Regional hub: Manufacturing in one country with shipments to nearby countries where timing is feasible.
- Cross-border shipment: Central manufacturing with direct shipment to sites, often higher operational risk for short half-life isotopes.
Decision drivers: isotope half-life, batch release requirements, frequency of dosing/imaging, customs reliability, and the maturity of nuclear medicine infrastructure.

3) Customs, permits, and paperwork: treat them as a core workstream

Unlike many conventional clinical programs, radiopharmaceutical shipments can require coordination across multiple authorities (health, customs, transport, and sometimes nuclear or radiation safety regulators). Paperwork failures are not “minor admin issues”—they can destroy a batch.

A practical sponsor approach:
- Create a country-specific import dossier: A standardized pack containing product description, safety documentation, shipping classification, and required permits.
- Pre-align with your logistics partner: Ensure they can manage controlled substances/radiation shipments and have airport-level handling experience.
- Plan for documentation constraints: Some submission systems impose file size and formatting limitations, which can impact how you structure supporting documents.
Risk mitigation: Maintain “pre-cleared” templates for invoices, certificates, and chain-of-custody records so each shipment is not a new negotiation.

4) Cold chain and handoffs: map every minute and every signature

Radiopharmaceutical trials require high integrity across handoffs—manufacturing release, airport handling, courier transfer, hospital receiving, radiopharmacy preparation (if applicable), and administration.
- Define temperature and shielding requirements: Include validated packaging and monitoring devices.
- Use chain-of-custody records: Document each transfer with time stamps and responsible parties.
- Plan for failed deliveries: What happens if a flight is canceled? If customs holds the shipment? If the site cannot dose a patient that day?
For short half-life isotopes, it may be more realistic to design protocols with flexible scheduling windows and backup dosing slots rather than a single “perfect” appointment that collapses with one delay.

5) Site readiness: nuclear medicine capability is necessary but not sufficient

Sites should be evaluated against operational capabilities that directly influence shipment success:
- Receiving readiness: Can the site receive shipments after hours? Who signs? Where is the secure holding area?
- Radiation safety workflow: Disposal, contamination procedures, monitoring, and staff training documentation.
- Imaging/therapy coordination: Scanner availability, staffing schedules, and patient flow.
- Contingency operations: Can the site reschedule quickly if dosing slips by hours?
Operational best practice: Run a “dry rehearsal” shipment to test handoffs, documentation, and receiving steps before the first patient.

6) Design a sponsor control tower for isotope-dependent trials

Because time is the critical resource, sponsors benefit from a simple control tower model:
- Shipment tracker: One dashboard for synthesis time, release, airport departure/arrival, customs status, courier pickup, and site receipt.
- Rapid decision protocol: A predefined decision tree for whether to proceed, reroute, or cancel based on delay thresholds.
- Communications cadence: Clear check-in times with manufacturing, courier, and site staff during dosing days.
This structure reduces last-minute improvisation and helps teams learn systematically from each shipment cycle.

FAQ: Radiopharmaceutical trial logistics in Latin America

1) What is the single biggest logistics risk for short half-life isotopes?

Border and airport unpredictability. A delay of hours can materially reduce dose viability, making preplanned routes and contingency options essential.

2) Should we prioritize local production even if it is more expensive?

Sometimes yes. Local production can reduce cross-border risk and improve dosing reliability, which may be more valuable than cost savings when early data is the goal.

3) How can sponsors reduce failed dosing days?

By selecting sites near reliable arrival points, rehearsing end-to-end shipments, maintaining documentation templates, and using a control tower to manage real-time decisions.

Conclusion: Radiopharmaceutical trials can be executed successfully in Latin America, but they require a logistics-first mindset. Build your protocol around half-life constraints, treat customs as a core workstream, and operate a shipment control tower. When logistics is engineered as a system—not handled as an afterthought—sponsors gain the reliability needed to generate high-quality clinical data on schedule.
June 24, 2026
Brazil’s 90‑Day ANVISA Clock for First‑in‑Human MedTech Studies: A Sponsor-Ready Timeline
Brazil’s 90‑Day ANVISA Clock for First‑in‑Human MedTech Studies: A Sponsor-Ready Timeline

For MedTech founders and regulatory leaders, the difference between a credible first‑in‑human (FIH) plan and an expensive science project often comes down to one question: when will we be cleared to start? In Latin America, Brazil is increasingly attractive because the regulatory environment is becoming more predictable for sponsors who prepare correctly. The biggest practical shift is that Brazil’s current framework is designed around a defined review window for ANVISA’s assessment of primary clinical‑trial petitions.

This article translates that “clock” into a sponsor-ready activation timeline—what to do first, what can run in parallel, and where teams still lose weeks. It is written for early-stage device companies planning a first-in-human or very early feasibility study and aiming to use Brazil’s speed without compromising compliance.

1) What the “ANVISA clock” changes (and what it does not)

A defined review window is only valuable if your submission is complete and internally consistent. In practice, teams still face delays from avoidable dossier defects, mismatched translations, missing proof of manufacturer authorization, or unclear risk management documentation.
- What changes: Sponsors can build a tighter critical path because the regulatory review is no longer an open-ended variable.
- What does not change: Poor dossier quality, unclear clinical rationale, and weak local operational readiness can still extend the activation timeline.
Think of the “90-day clock” as a predictability multiplier. It rewards teams that treat activation as a program, not a document handoff.

2) A sponsor-ready activation timeline for FIH MedTech studies in Brazil

Below is a practical timeline for a single-country Brazil activation that is common for early-stage MedTech programs. Actual sequencing depends on device risk classification, study design, and whether you already have an audited quality system and finalized manufacturing documentation.

Phase A (Weeks 0–2): Define your regulatory “story” and activation plan

Before drafting anything, align internal stakeholders on four elements:
- Clinical intent: What data must your FIH generate (safety, usability, performance, feasibility) to unlock your next milestone?
- Risk position: A simple, defensible summary of hazards, mitigations, and residual risk.
- Operational model: Which hospitals, investigators, and vendor partners can execute within your required timeline?
- Regulatory endpoints: Which approvals are required (ethics, ANVISA, contracts, importation readiness) and what is the critical path?
Common failure mode: Teams finalize the protocol without deciding how the device will be imported, stored, serviced, and returned—creating late-stage amendments and logistics rework.

Phase B (Weeks 2–6): Build the dossier as an integrated package

FIH dossiers fail not because the science is wrong, but because the package is incoherent. Aim to produce a “single narrative” across these documents:
- Protocol + investigator materials: Clear objectives, endpoints, and monitoring plan.
- Device technical file excerpts: What the device is, how it works, and how it is controlled.
- Risk management + usability: Evidence that use-related risks are addressed in training, labeling, and design controls.
- Manufacturing and quality evidence: Enough to support safety and traceability expectations.
- Clinical rationale: Why FIH is appropriate now and why Brazil’s sites can execute safely.
Best practice: Maintain a “regulatory crosswalk” table mapping each claim in the protocol (device description, intended use, risk controls) to supporting evidence in the technical file. This prevents contradictions that trigger regulator questions.

Phase C (Weeks 4–8): Ethics readiness and site operational lock

While the dossier is being finalized, lock down the operational prerequisites that routinely delay activation:
- Site feasibility confirmation: Not generic interest—confirmed equipment compatibility, OR slots, and patient flow.
- Contracts and budget: Early alignment with hospital administration avoids last-minute legal stalls.
- Training plan: How will you prove investigator training and competency for first uses?
- Device logistics: Importation responsibilities, packaging validation, and field support processes.
FIH timelines improve when ethics, contracts, and logistics are treated as first-class workstreams—not “post-approval tasks.”

Phase D (Weeks 8–20): Regulatory review window and question management

Once submitted, your main objective is to minimize cycles. Even with a defined review window, questions can reset practical timelines. Sponsors can reduce rework by planning for:
- Rapid response capability: A named owner who can coordinate answers across engineering, QA/RA, and clinical.
- Document control discipline: Consistent versioning, translation control, and traceability of edits.
- Pre-drafted evidence packets: Sterilization summary, labeling package, risk management summary, device master record excerpts.
Tip: When responding to questions, avoid “new storylines.” Keep answers anchored to the original intended use and risk position unless a formal amendment is required.

3) Where FIH teams still lose time in Brazil

Even with improved predictability, sponsors still lose weeks in three recurring areas:
- Under-scoped translations: Technical and clinical translations require domain expertise, not generic language services.
- Unclear importer/registration model: If responsibilities for importation and regulatory representation are not defined, device availability becomes the bottleneck.
- Late site readiness: Contracts, budgets, and first-case scheduling often lag behind the regulatory path.
The fix is not “work faster.” The fix is to design an activation system where regulatory, quality, and operations are integrated from day one.

4) A practical checklist before you start your FIH activation
- Have we defined the minimum FIH dataset required for our next financing or partnership step?
- Is our intended use and risk position consistent across protocol, device description, and labeling?
- Do we have a locked plan for importation, storage, servicing, and returns?
- Are our sites contract-ready with budgets aligned and first-case logistics mapped?
- Do we have a “rapid response” team prepared for regulator questions?
FAQ: Brazil first‑in‑human MedTech study activation

1) Can a defined review window guarantee my exact start date?

No. It improves predictability, but start dates still depend on dossier quality, question cycles, ethics timing, contracts, and logistics.

2) What is the most common avoidable delay for early-stage sponsors?

Incoherent documentation—contradictions between protocol claims and device evidence, plus weak translation and version control.

3) Should we activate Brazil as a stand-alone FIH or part of a multi-country plan?

Many MedTech startups start with a focused single-country activation to generate clean early human data quickly, then expand once operational learning is captured.

Conclusion: Brazil’s evolving framework can give FIH sponsors a more predictable regulatory path—but only if you build a dossier and activation plan that is operationally executable. Treat the “ANVISA clock” as a program milestone, not a date, and you can turn regulatory predictability into faster, safer first-in-human learning.
June 24, 2026
Argentina’s $8 Billion Clinical Research Commitment: What It Means For Medtech Startup FIH Trials In 2026
Argentina’s $8 Billion Clinical Research Commitment: What It Means for MedTech Startup FIH Trials in 2026

By Julio Martinez-Clark, CEO, bioaccess® | June 2026

The Signal That Most MedTech Founders Missed

In late May 2026, seven of the world’s largest pharmaceutical companies — Pfizer, Merck, Roche, Novartis, Bristol Myers Squibb, GSK, and Sanofi — pledged a combined $8 billion in Argentine clinical research investment over the 2026–2032 period. Days later, Argentina’s national drug and food regulator, ANMAT, published Disposición 2978/2026, cutting import tariffs on medicines and medical devices by 50 to 70 percent, effective June 1, 2026.

The pharma industry picked up the $8 billion figure immediately. MedTech largely did not. That gap is worth examining — because for a structural heart, neuromodulation, or radiopharmaceuticals startup planning a first-in-human (FIH) trial in the next 18 months, these two policy events together represent one of the most significant shifts in the LATAM early-phase clinical research environment in a decade.

This piece walks through what actually changed, why it matters specifically for device and biotech FIH programs, and how to think about Argentina as part of a first-in-human trial site strategy in 2026.
What Changed: Disposición 2978/2026 and the $8B Commitment

The Tariff Reduction

Disposición 2978/2026 is not a pilot, a phase-in, or a proposed amendment — it is in effect. Import tariffs on medicines and medical devices were reduced by 50 to 70 percent, effective June 1, 2026. For a device company running an FIH feasibility study, this has a direct, calculable effect on budget: investigational devices entering Argentina for clinical use carry materially lower landed cost.

In early-phase device trials, the investigational product is often the single largest variable cost item outside of site and monitoring fees. A 50 percent reduction in import tariffs on a novel transcatheter device, for example, can change the per-patient cost model meaningfully — particularly for seed-stage and Series A sponsors working with sub-$15 million clinical trial budgets.

The tariff change also simplifies regulatory logistics. One of the historically cited friction points in Argentine FIH trials has been the import authorization process for investigational devices that were not commercially registered in Argentina. Lower tariff classification, combined with ANMAT’s active throughput cadence, reduces one layer of that friction.

The $8 Billion Pharma Commitment

The $8 billion multi-company pledge is not a single infrastructure project — it represents committed clinical research spend across seven major sponsors over six years. The practical implications:

Site infrastructure: When Pfizer, Roche, and Novartis are committing multi-year research spend to Argentina, they are investing in investigator networks, clinical infrastructure, and regulatory capacity at sites. This infrastructure — trained investigators, GCP-compliant facilities, ethics committees with high-volume experience — is precisely what a MedTech startup needs for an FIH feasibility study.

Regulatory capacity: ANMAT’s workload will increase, but so will its institutional capacity. Regulators that process high volumes of multi-national submissions develop faster, more predictable review cycles. Argentina approved 290 new clinical studies in 2025, an 8 percent year-over-year increase, with more than 1,000 active trials and 50,000+ participants enrolled. The $8 billion commitment is a signal that this trajectory accelerates.

International credibility: Large pharma’s visible commitment to Argentina as a clinical research destination reduces the country risk perception that smaller device sponsors sometimes encounter when presenting LATAM FIH data to US investors and regulatory reviewers.
Practical Considerations for MedTech Sponsors

A realistic timeline from engagement to first patient for a novel device FIH study in Argentina: Weeks 1–4 site identification; Weeks 5–8 ethics committee; Weeks 6–12 ANMAT authorization; Weeks 10–16 site initiation; Weeks 14–20 first patient in. The Argentina FIH environment also benefits from bioaccess® multi-country capability covering Argentina and Colombia as primary FIH jurisdictions.
Sources

Argentina ANMAT Disposición 2978/2026 (effective June 1, 2026)

Julio Martinez-Clark LinkedIn, June 6, 2026: Seven pharma companies pledged $8B in Argentine clinical research investment

MedDeviceGuide, June 14, 2026: Argentina ANMAT Medical Device Register Market Analysis 2026

FDA 21 CFR 812.28 — Acceptance of Data from Studies Conducted Outside the United States
June 22, 2026
ANVISA confirms academic medical device studies in Brazil can skip regulatory review: what ANVISA Protocol 2025289179 and RDC 837/2023 mean for sponsors
ANVISA confirms academic medical device studies in Brazil can skip regulatory review: what ANVISA Protocol 2025289179 and RDC 837/2023 mean for sponsors

Originally published March 18, 2026. Rebuilt and updated June 20, 2026 with verbatim primary-source quotes from ANVISA Protocol 2025289179 and a dedicated section on the parallel importation authorization process.

On December 9, 2025, ANVISA’s General Office of Technology Products for Health (GGTPS) issued a written clarification — Protocol No. 2025289179, signed by ANVISA officer Rafaela de Lima Avelino — confirming that strictly academic, non-commercialization clinical studies with medical devices can proceed in Brazil without prior ANVISA regulatory review. The clarification applies regardless of device risk class, meaning Class III and Class IV investigational devices qualify for this pathway if the study protocol explicitly excludes any intent to pursue Brazilian commercialization. Ethics Committee approval through CEP/CONEP remains required, but no ANVISA dossier is filed. For MedTech sponsors designing first-in-human (FIH) programs and evaluating where to run their earliest clinical evidence, this confirmation meaningfully changes the Brazil equation.

What ANVISA’s December 9, 2025 protocol actually says

ANVISA Protocol 2025289179 was issued in response to a direct query about the scope of regulatory oversight for academic, non-commercialization device studies under Brazilian law. The GGTPS (Gerência Geral de Tecnologia de Produtos para a Saúde) response confirmed the following position:

Clinical investigations involving medical devices that are conducted exclusively for academic or scientific purposes — and that carry no present or prospective intent for commercialization in the Brazilian market — are not subject to prior ANVISA regulatory review under RDC 837/2023. Such studies require only Ethics Committee review and approval through the CEP/CONEP system, in line with the framework established under Lei 14.874/2024 and Decreto 12.651/2025.

ANVISA’s verbatim language in the response (original Portuguese, with translation):

“São passíveis de anuência emitida pela Anvisa apenas as investigações clínicas para dispositivos médicos cujo objetivo seja solicitar o registro do produto na Anvisa. Desta forma, em sendo o estudo realizado em ‘caráter estritamente acadêmico/científico e não possui finalidade de registro sanitário’ então é dispensável o atendimento a RDC supracitada.”

Translation: “Only clinical investigations for medical devices whose objective is to request product registration with Anvisa are subject to consent issued by Anvisa. Therefore, if the study is carried out in a ‘strictly academic/scientific character and does not have the purpose of sanitary registration,’ then compliance with the aforementioned RDC is dispensable.”

The protocol makes explicit that this exemption from pre-study ANVISA review applies across all device risk classes. A Class III or Class IV investigational device used in a study that meets the academic, non-commercialization criteria is treated the same as a lower-risk device for purposes of ANVISA pre-approval — the risk class does not trigger mandatory ANVISA review in this pathway.

This is a significant regulatory clarification because the text of RDC 837/2023 itself, read in isolation, can create ambiguity about whether the exemption extends to higher-risk devices. Protocol 2025289179 resolves that ambiguity directly, in writing, from the responsible ANVISA directorate.

Why this matters for Class III and IV device studies

The prevailing assumption among many MedTech legal and regulatory teams has been that ANVISA review is categorically required before any clinical investigation of a Class III or IV device in Brazil, full stop. Protocol 2025289179 clarifies that this assumption is incorrect when the study is academic and non-commercialization in nature.

The practical implications are substantial. A sponsor developing a novel implantable device, an active implantable device, a life-sustaining device, or any other product that falls into Brazil’s higher risk classifications can — provided the study protocol is correctly constructed — conduct a first-in-human study at a Brazilian academic medical center under CEP/CONEP review alone. No ANVISA Investigational Device Exemption equivalent dossier. No ANVISA review timeline. No ANVISA fee.

For sponsors whose Brazilian clinical data will be used to support an FDA Investigational Device Exemption (IDE) or CE Mark application — and who have no immediate intent to pursue Brazilian ANVISA registration — this pathway keeps the regulatory burden proportionate to the study’s actual purpose.

The distinction that triggers the exemption is not the device class. It is the study’s purpose. If the protocol is academic and the sponsor’s intent is non-commercialization in Brazil, the exemption applies.

The four reinforcing primary sources

The ANVISA clarification in Protocol 2025289179 does not stand alone. Four primary sources together form a coherent legal and regulatory basis for the CEP-only pathway in academic device studies.

RDC 837/2023 — Brazilian Medical Device Clinical Investigation Regulation

RDC 837/2023 is ANVISA’s operative regulation governing clinical investigations with medical devices. Article structures within the regulation define the scope of mandatory pre-study ANVISA review and carve out studies of a purely academic or scientific nature from that mandatory pathway. The regulation does not itself specify a risk-class threshold for the academic exemption, which is what created interpretive uncertainty — and which Protocol 2025289179 now resolves by confirming the exemption applies across all classes.

Lei 14.874/2024 — Brazilian Clinical Research Law

Lei 14.874/2024, enacted in 2024, is the overarching federal law governing clinical research in Brazil. Articles 2 XXI and 2 XXXII define key terms including “clinical investigation” and “strictly academic study,” drawing the boundary between studies that are and are not subject to full regulatory oversight. Article 58 addresses the CEP/CONEP approval pathway as the operative approval requirement for studies that fall outside mandatory ANVISA pre-review. The definitions in Lei 14.874/2024 are the legal anchor for the academic/non-commercialization distinction used in RDC 837/2023 and reinforced in Protocol 2025289179.

Decreto 12.651/2025 — Operative Since October 8, 2025

Decreto 12.651/2025, which entered into force on October 8, 2025, provides the executive regulatory framework implementing Lei 14.874/2024. Article 9 of the Decreto is particularly relevant: Item II describes the conditions under which a study requires full regulatory submission, while Item III describes the conditions — including the academic and non-commercialization criteria — under which a study may proceed under Ethics Committee review alone. The Decreto’s operative date (October 8, 2025) precedes the issuance of Protocol 2025289179 (December 9, 2025), confirming that the ANVISA clarification was issued in the context of a legal framework already in effect.

ANVISA Protocol 2025289179 — GGTPS Written Response, December 9, 2025

The written response from the General Office of Technology Products for Health (GGTPS — Gerência Geral de Tecnologia de Produtos para a Saúde), signed by ANVISA officer Rafaela de Lima Avelino, is the direct primary source confirming that the academic, non-commercialization exemption applies to all device risk classes. It is not a guidance document or a policy statement — it is a written regulatory position issued in response to a specific factual query. Its evidentiary weight for sponsors planning a CEP-only pathway is therefore high.

Real-world precedent

The academic/non-commercialization device study pathway in Brazil has not been purely theoretical in the period following the legislative and regulatory changes of 2024 and 2025. Recent Class III-equivalent device first-in-human studies have been conducted at leading academic medical centers in São Paulo under Ethics Committee approval, with no ANVISA dossier filed and no ANVISA enforcement action. These studies were sponsor-supported in their funding structure, with the protocols characterized as academic in purpose, and were designed to generate the clinical data required to support U.S. FDA IDE filings.

bioaccess® does not disclose the identities of the sponsors, sites, or devices involved in its programs. What can be stated is that the pattern has emerged consistently: a MedTech sponsor with a novel device, a first-in-human objective, and no near-term Brazilian commercialization intent has been able to activate a study in Brazil without opening an ANVISA regulatory dossier, provided that the protocol was appropriately structured and that the importation authorization for the investigational device was obtained in parallel.

Practitioners’ guides published in 2025 and 2026 acknowledge the academic study pathway as an established mechanism; specific commentary varies, and sponsors should rely primarily on the four primary sources cited above rather than on secondary guides. Sponsors who have engaged Brazilian regulatory counsel in advance of protocol finalization have generally navigated the CEP/CONEP process cleanly.

Important caveats every sponsor should know

Protocol 2025289179 is an important clarification, but it does not eliminate regulatory complexity. Sponsors considering the CEP-only pathway should understand four caveats before contracting.

Caveat 1: The protocol must explicitly and unambiguously state no Brazilian registration intent.

The academic/non-commercialization exemption is conditioned on the study’s purpose as documented. A protocol that is silent on Brazilian commercialization intent, or that includes ambiguous language such as references to potential future market development in Brazil, may not meet the threshold. Sponsors should work with Brazilian regulatory counsel to ensure the protocol language is explicit: the study is conducted for academic or scientific purposes, and the sponsor does not intend to use the data to support a Brazilian ANVISA registration application.

Caveat 2: ANVISA importation clearance (RDC 172/2017) for the investigational device remains required.

Obtaining CEP/CONEP approval without an ANVISA regulatory dossier does not exempt the sponsor from obtaining ANVISA importation clearance under RDC 172/2017 for the unregistered investigational device into Brazil. Importation authorization is a separate administrative process that runs in parallel with site activation. It is mechanically distinct from regulatory review of the study itself, and it must be completed before the device can physically enter Brazil for use in the study. Sponsors who plan for CEP/CONEP approval but fail to account for importation authorization timelines will encounter delays at the device logistics stage. bioaccess® manages this process as part of its standard activation workflow. See the dedicated importation section below for the full process.

Caveat 3: CEP-only data cannot later be used for Brazilian registration. This is categorical, not a soft preference.

This is the single most consequential limitation in Protocol 2025289179, and it is stated in unambiguous terms in ANVISA’s December 9, 2025 response. The verbatim Portuguese:

“Entretanto, alertamos que os dados obtidos em investigações clínicas realizadas no Brasil com dispositivos médicos sem anuência prevista na RDC nº 837/2023, não poderão ser utilizados para comprovação de desempenho, eficácia e segurança junto à Anvisa para fins de registro em petições futuras.”

Translation: “However, we warn that data obtained in clinical investigations carried out in Brazil with medical devices without the consent provided for in RDC No. 837/2023 cannot be used to prove performance, efficacy, and safety to Anvisa for registration purposes in future petitions.”

A sponsor who later decides to commercialize the device in Brazil must run a separate, ANVISA-supervised registration study — the CEP-only EFS data is regulatorily inert for Brazilian registration purposes. This is not a position bioaccess® can negotiate or work around. It is the explicit text of ANVISA’s written confirmation, and it must be reflected in the sponsor’s regulatory strategy from day one. Sponsors who have any plausible path to Brazilian commercialization in their long-range plan should obtain a formal legal opinion on this point before choosing the CEP-only route.

Caveat 4: Commercially-sponsored EFS studies warrant Brazilian legal opinion.

The protocol-level distinction between an academic institution-led study and a commercially-sponsored Early Feasibility Study (EFS) involves nuances that are not fully resolved by RDC 837/2023 or Protocol 2025289179 alone. A commercially-structured EFS where the sponsor has meaningful involvement in study design, execution oversight, and data ownership introduces questions about whether the study meets the academic characterization under Lei 14.874/2024. This warrants a formal opinion from qualified Brazilian legal and regulatory counsel before the sponsor contracts for study execution.

bioaccess® can refer sponsors to experienced Brazilian regulatory counsel and can coordinate the legal opinion process as part of trial planning. We do not substitute our operational expertise for legal advice, and we recommend that sponsors seeking certainty on these questions obtain a written legal opinion before committing to the CEP-only pathway.

How the investigational device gets into Brazil — the importation layer ANVISA still controls

ANVISA Protocol 2025289179 removes the requirement for pre-study ANVISA review of the clinical investigation itself. It does not remove ANVISA’s authority over what enters Brazil. Any foreign investigational medical device — regardless of whether the underlying study is registrational or non-registrational — requires ANVISA importation clearance before it can clear Brazilian customs. This is not a scientific review of the study; it is a separate administrative process handled by a different ANVISA unit, and it must be properly set up before the first device unit ships.

Two distinct ANVISA functions, two distinct ANVISA units

The clinical-trial review function (which Protocol 2025289179 deemed dispensable for academic, non-commercialization studies) sits with GGTPS — the Gerência Geral de Tecnologia de Produtos para a Saúde. The importation clearance function sits with PAFPS — Posto de Anuência de Importação de Produtos para Saúde, ANVISA’s Port, Airport, and Border post operating at points of entry. The two units operate under different regulations and different timelines. A sponsor running a CEP-only EFS is exempt from GGTPS clinical review but is not exempt from PAFPS importation clearance.

ANVISA’s own clinical-research FAQ (CPPRO/GGTPS, November 13, 2024) is explicit on this point: for device clinical research outside DICD scope, “o processo de importação de dispositivos médicos … para fins de investigação clínica deve ser realizado como importação de bens e produtos destinados à pesquisa científica ou tecnológica e à pesquisa envolvendo seres humanos, de acordo com as Resoluções RDC nº 172/2017 e RDC nº 613/2022 e suas atualizações” — meaning the RDC 172/2017 research-importation pathway is the operative mechanism.

Two importation pathways — and which one applies to non-registrational studies

The applicable importation route is determined by the study’s purpose, and the two pathways are structurally distinct and non-overlapping.

For studies that are intended to support Brazilian ANVISA registration (DICD-filed studies), the operative petition code is 90351 (“Anuência de Importação de produtos para saúde sob Pesquisa Clínica”), with regulatory basis in RDC 548/2021 and Chapters XXVI and XXVII of the Annex to RDC 81/2008. Under this pathway, the importer must hold an Autorização de Funcionamento (AFE) under RDC 16/2014, must submit a Termo de Responsabilidade per Chapter XXVII of the RDC 81/2008 Annex, and the import is anchored to an ANVISA-issued CE, CEE, or “Documento para Importação de Produto(s) sob Investigação” tied to the DICD authorization.

For non-registrational EFS studies — the scenario addressed throughout this post — the applicable framework is RDC 172/2017 (as amended by RDC 613/2022), specifically Article 5, which governs importation of products under sanitary surveillance intended for “pesquisa envolvendo seres humanos sem fins de registro” (human research without registration purpose). RDC 172/2017 Article 1 item XIII defines this category in language that maps exactly to Lei 14.874/2024 Article 2 item XXXII. Article 7 of RDC 172/2017 confirms the structural separation: the research-importation provisions explicitly do not apply to registration-purpose studies, which use the DICD pathway. This produces a clean, binary, non-overlapping framework.

Under the RDC 172/2017 pathway:
– No AFE is required. Importers operating under RDC 172/2017 are explicitly exempt from the Autorização de Funcionamento requirement, per the 2024 ANVISA GCPAF workshop guidance and RDC 860/2024.
– No CE, CEE, or “Documento para Importação” is issued. Those documents are DICD-linked and do not exist in the non-registration pathway.
– The importation petition is filed via SISCOMEX with an LPCO (Licença, Permissão, Certificado ou Outro Documento) submission to PAFPS.
– The specific 90xxx PAFPS petition code applicable to non-registrational device imports is not enumerated on ANVISA’s published April 2024 codes page — it is confirmed with the customs broker at filing time based on the device type and study context. Sponsors should engage a Brazilian customs broker with current PAFPS experience to confirm the operative code for the specific shipment. bioaccess® coordinates this through its Brazilian importation partner.

Importer of record — who can legally bring the device into Brazil

Under RDC 172/2017 Article 5 §4, importation by a natural person (pessoa física) of products subject to ANVISA regularization that have not yet been regularized is explicitly prohibited. The importer of record must be a Brazilian legal entity (pessoa jurídica). The foreign sponsor, unless it has a registered Brazilian subsidiary qualifying as a research importer, cannot act as importer directly.

When the foreign sponsor is not the importer of record, the Brazilian importing entity acts under a delegation arrangement, and a Termo de Responsabilidade per Annex I of RDC 172/2017 must be signed by the Brazilian importer. RDC 613/2022 strengthened this Termo de Responsabilidade to include declaration of the inventory of all prior importations for the same research project, allowing PAFPS to verify quantities against the CEP-approved protocol.

Article 6 of RDC 172/2017 establishes that importation by a legal entity for human research with unregularized products must be mandatorily preceded by CEP and, where applicable, CONEP approval of the study. This means the importation petition is filed after ethics committee clearance — not in advance of it. The Termo de Responsabilidade declares the CEP/CONEP approval status.

Practical timeline — meaningfully faster than the registrational pathway

The PAFPS authorization under RDC 172/2017 Article 5 §1 is required to be completed within 48 hours after the arrival of the goods in national territory, provided the SISCOMEX LI has been pre-registered and all required documentation is in order. For institutions credentialed by CNPq (the Brazilian National Council for Scientific and Technological Development) under a tax-exemption regime with the Federal Revenue Service, Article 5 §2 provides for automatic deferral of the SISCOMEX import license — meaning PAFPS clearance is granted without manual ANVISA review of the petition.

This is materially faster than the DICD-linked registrational importation pathway, which involves ANVISA technical review and typically runs in the multi-week range. For a sponsor running a CEP-only EFS through a CNPq-credentialed institution or a Brazilian research importer with appropriate credentialing, the device can be on-site within days of arrival in Brazil, not weeks.

Tax and customs treatment — meaningful benefits for credentialed importers

Investigational devices entering Brazil under the RDC 172/2017 research-importation pathway qualify for a tax exemption stack that is not available under standard commercial importation:
- Lei 8.010/1990 provides exemption from Imposto de Importação (II), Imposto sobre Produtos Industrializados (IPI), and Adicional ao Frete para Renovação da Marinha Mercante (AFRMM) for goods imported by CNPq-credentialed scientific and technological institutions or by entities importing through them.
- Convênio ICMS 104/89 provides exemption from Imposto sobre Circulação de Mercadorias e Serviços (ICMS) at the state level, on the same terms.
In practice, this means a CNPq-credentialed Brazilian research importer pays minimal tax and customs duty on the inbound investigational device shipment. For a foreign sponsor that has not yet established Brazilian research-importer credentialing, working with an importer of record that holds CNPq credentialing is the most direct route to capture these benefits. bioaccess® coordinates this credentialing pathway through its Brazilian importation partner.

Documentation checklist for the RDC 172/2017 importation petition

The core documentation required to support the PAFPS importation petition under RDC 172/2017 includes:
- The CEP-approved (and, where applicable, CONEP-approved) study protocol, with the academic, non-commercialization purpose statement clearly documented
- Termo de Responsabilidade signed by the Brazilian legal-entity importer of record, per Annex I of RDC 172/2017 (as updated by RDC 613/2022 to include inventory of prior importations)
- Commercial invoice and bill of lading from the foreign supplier
- Delegation document from the foreign sponsor authorizing the Brazilian importer, when the sponsor and importer are distinct legal entities
- Secondary and external packaging labels for the investigational device showing the CEP-approved clinical protocol number, storage conditions (temperature, humidity, light exposure requirements), and lot or serial number sufficient for traceability throughout the study
- SISCOMEX LI registration with the PAFPS-appropriate petition code, confirmed with the customs broker at filing time
Packaging label compliance is frequently a cause of delay at the customs clearance stage. Labels must be prepared in Portuguese or in a bilingual format acceptable to ANVISA, and they must include all required fields before the shipment is tendered to the carrier.

bioaccess® manages the full importation authorization workflow as part of its CRO scope, coordinating between the foreign sponsor, the Brazilian importer of record (with CNPq credentialing where appropriate to access the Lei 8.010/1990 and Convênio ICMS 104/89 tax exemptions), and PAFPS at the point of entry. For sponsors unfamiliar with the Brazilian research-importation framework, this is the component of study activation where the right local partner pays for itself in both timeline and total landed cost.

What this means for first-in-human programs

For MedTech sponsors evaluating where to run their first-in-human study, Protocol 2025289179 and the surrounding legal framework make Brazil more competitive than the regulatory overhead of the U.S. or EU pathway for academic device studies.

A properly structured CEP-only study in Brazil activates through the ethics committee system. CEP/CONEP review timelines, while variable, have been compressing since the introduction of Lei 14.874/2024’s 90-business-day ANVISA review limit (which now creates a predictable ceiling on full-regulatory-pathway timelines as well). For academic studies, the absence of an ANVISA pre-submission requirement means the critical path is defined by CEP/CONEP, site contracting, and device importation — all of which bioaccess® manages as an integrated workflow.

Brazil offers a combination of clinical infrastructure, patient population scale, experienced investigators at academic medical centers, and now a clarified regulatory pathway that reduces the administrative burden for academic device studies. For a MedTech startup running its first FIH study and targeting an FDA IDE or CE Mark — not a Brazilian commercial registration — the cost and timeline differential relative to conducting the same study in the U.S. or a Western European country is meaningful.

bioaccess® was purpose-built for exactly this scenario: startups that need a high-quality, cost-efficient first-in-human study that generates FDA-credible data, with a CRO partner that understands both the operational and regulatory landscape in Latin America. We back our programs with a 12-month timeline guarantee because we have designed our workflows — including ANVISA importation authorization, CEP/CONEP management, and site activation — to run on a defined schedule.

If you are evaluating Brazil for a device first-in-human study and want to understand whether the CEP-only pathway applies to your specific protocol and device class, the right next step is a direct conversation. Schedule a free consultation at bioaccessla.com/book-a-meeting.

Frequently asked questions

bioaccess® is a contract research organization (CRO) specializing in first-in-human clinical trials and market access for medical devices and biopharma in Latin America. This post is intended for general informational and educational purposes and does not constitute legal, regulatory, or medical advice. Sponsors should obtain qualified legal and regulatory counsel for their specific programs.
June 20, 2026
Julio Martinez-Clark on Tech Can’t Save Us: Accelerating MedTech and First-in-Human Success

Julio Martinez-Clark, co-founder and CEO of bioaccess®, recently joined host Paul David on Tech Can’t Save Us — the podcast by Literal Humans that explores technology’s real-world limits and what it takes to build companies that last. The episode is now live across all major podcast platforms.

Listen on Apple Podcasts | Listen on Spotify | Full episode on the TCSU website

The “Valley of Death” — And How MedTech Startups Survive It

The conversation opens with a sobering reality: roughly 90% of healthcare startups fail — not because their technology is flawed, but because they exhaust their capital before generating the clinical data needed to raise their next round or secure an exit.

With monthly burn rates averaging $300,000 to $400,000, the clock is always running. The fastest path off the clock is the fastest path to first-in-human data.

That’s the problem bioaccess® was purpose-built to solve.

What bioaccess® Does — and Why LATAM

bioaccess® is the world’s first contract research organization (CRO) built specifically around first-in-human (FIH) clinical trials. By combining deep site relationships, regulatory expertise, and operational infrastructure across Latin American markets — including Panama and El Salvador — bioaccess® compresses clinical timelines by up to 40%.

As Julio explained on the podcast, speed in LATAM doesn’t mean cutting corners. Every trial bioaccess® runs adheres strictly to ICH and GCP guidelines — the same international standards required by the FDA and EMA. What differs is execution: rapid site activation, predictable patient recruitment, and a team that has done this before, in these markets, for these device types.

Democratizing Access to Life-Saving Innovation

One of the most compelling threads in the conversation is the human dimension of clinical research. The patients who participate in first-in-human trials in lower-income settings often have no other access to advanced medical care. For them, participation isn’t a transaction — it’s a lifeline.

Julio discussed how this dynamic shapes bioaccess®’s philosophy: that moving faster on clinical timelines is not just a business imperative but a moral one. Compassionate, high-quality clinical research restores dignity and delivers access to innovations that would otherwise take years longer to reach these communities.

Building Without Outside Capital

The episode also covers bioaccess®’s self-funded growth strategy — a deliberate choice that has kept the company focused on delivering value to sponsors rather than chasing metrics that serve investors. Julio shares the discipline required to grow this way and the common mistakes he sees first-time founders make when they let fundraising urgency drive clinical decision-making.

La Cebolla de Pandora

Julio reflects on the period he spent writing La Cebolla de Pandora — a book that gave him the space to examine his own assumptions about what success, purpose, and impact actually mean in the context of a company trying to change how medicine reaches people.

Listen Now

The full episode runs 26 minutes. You can find it on the Tech Can’t Save Us website, Apple Podcasts, Spotify, and all major platforms.

If you’re a MedTech or biopharma startup navigating your path to first-in-human data, explore how bioaccess® can compress your timeline →

Tech Can’t Save Us is produced by Literal Humans, a marketing agency focused on technology and innovation.

June 18, 2026

Author: Julio Martinez-Clark

The Most Expensive Vendor Decision You Will Make Before Your Series B

Question 1: “What percentage of your active studies are first-in-human?”

Question 2: “What is your documented median time from IND/IDE submission to site initiation in your primary jurisdiction?”

Question 3: “Have you produced a data package accepted by FDA from a non-U.S. trial in the past 36 months?”

Question 4: “What is your per-patient cost range for a 10-to-15 patient FIH study in your primary jurisdiction?”

Question 5: “Can you execute an EFS submission and manage a concurrent OUS FIH study under a single operational team?”

How to Use This Checklist

Ready to Run the Evaluation?

Sources

Introduction

The Rise of Latin America as a Clinical Trial Destination

Identifying Key Hotspots for Clinical Trials in Latin America

Navigating Regulatory Challenges in Latin American Clinical Trials

Leveraging Technology for Enhanced Clinical Trial Efficiency

Ensuring Equitable Access to Clinical Trials in Latin America

Conclusion

Frequently Asked Questions

List of Sources

Radiopharmaceutical Trial Logistics in Latin America: A Sponsor’s Playbook for Isotope Supply and Shipment Risk

1) Why radiopharmaceutical logistics behave differently than “regular” clinical supply

2) Build your “isotope availability model” before you lock the protocol calendar

3) Shipment acceptance: treat documentation as a quality system, not paperwork

4) Latin America-specific risk: cross-border variability and limited buffer time

FAQ

Radiopharmaceutical Clinical Trials in Latin America: A Logistics Playbook for Isotope-Dependent Studies

1) Start with the “half-life reality” and build the trial around it

2) Build a supply strategy: local production, regional hubs, or cross-border shipment

3) Customs, permits, and paperwork: treat them as a core workstream

4) Cold chain and handoffs: map every minute and every signature

5) Site readiness: nuclear medicine capability is necessary but not sufficient

6) Design a sponsor control tower for isotope-dependent trials

FAQ: Radiopharmaceutical trial logistics in Latin America

1) What is the single biggest logistics risk for short half-life isotopes?

2) Should we prioritize local production even if it is more expensive?

3) How can sponsors reduce failed dosing days?

Brazil’s 90‑Day ANVISA Clock for First‑in‑Human MedTech Studies: A Sponsor-Ready Timeline

1) What the “ANVISA clock” changes (and what it does not)

2) A sponsor-ready activation timeline for FIH MedTech studies in Brazil

Phase A (Weeks 0–2): Define your regulatory “story” and activation plan

Phase B (Weeks 2–6): Build the dossier as an integrated package

Phase C (Weeks 4–8): Ethics readiness and site operational lock

Phase D (Weeks 8–20): Regulatory review window and question management

3) Where FIH teams still lose time in Brazil

4) A practical checklist before you start your FIH activation

FAQ: Brazil first‑in‑human MedTech study activation

1) Can a defined review window guarantee my exact start date?

2) What is the most common avoidable delay for early-stage sponsors?

3) Should we activate Brazil as a stand-alone FIH or part of a multi-country plan?

Argentina’s $8 Billion Clinical Research Commitment: What It Means for MedTech Startup FIH Trials in 2026

The Signal That Most MedTech Founders Missed

What Changed: Disposición 2978/2026 and the $8B Commitment

The Tariff Reduction

The $8 Billion Pharma Commitment

Practical Considerations for MedTech Sponsors

Sources

ANVISA confirms academic medical device studies in Brazil can skip regulatory review: what ANVISA Protocol 2025289179 and RDC 837/2023 mean for sponsors

What ANVISA’s December 9, 2025 protocol actually says

Why this matters for Class III and IV device studies

The four reinforcing primary sources

Real-world precedent

Important caveats every sponsor should know

How the investigational device gets into Brazil — the importation layer ANVISA still controls

Two distinct ANVISA functions, two distinct ANVISA units

Two importation pathways — and which one applies to non-registrational studies

Importer of record — who can legally bring the device into Brazil

Practical timeline — meaningfully faster than the registrational pathway

Tax and customs treatment — meaningful benefits for credentialed importers

Documentation checklist for the RDC 172/2017 importation petition

What this means for first-in-human programs

Frequently asked questions

The “Valley of Death” — And How MedTech Startups Survive It

What bioaccess® Does — and Why LATAM

Democratizing Access to Life-Saving Innovation

Building Without Outside Capital

La Cebolla de Pandora

Listen Now