Best Practices for First in Human Trials in Brazil: Strategies for Success

Introduction

Brazil’s emergence as a key player in first-in-human trials presents both opportunities and challenges. Driven by a treatment-naive patient population and significant regulatory reforms, Brazil has rapidly positioned itself as a vital hub for clinical research.

With the recent changes in Law No. 14,874/2024, the approval process has been streamlined, offering sponsors a remarkable opportunity to expedite their clinical research endeavors. However, navigating Brazil’s evolving regulatory landscape can be daunting for stakeholders.

How can they effectively leverage Brazil’s unique advantages while overcoming the inherent challenges of patient recruitment and regulatory compliance? To succeed in early-stage clinical trials, stakeholders need to grasp these dynamics.

Understand the Landscape of First-in-Human Trials in Brazil

Brazil has emerged as a pivotal hub for first in human trial Brazil research, fueled by its diverse and treatment-naive patient population. The recent enactment of Law No. 14,874/2024 has reshaped the regulatory landscape significantly, reducing approval timelines from an average of 265 days to just 90 days. This reform simplifies the process. It also enhances the country’s appeal for first in human trial Brazil. Consequently, sponsors can expedite their research and development initiatives.

The Brazilian regulatory body, ANVISA, plays a crucial role in supervising research studies, ensuring that they conform to international benchmarks such as ICH-GCP. This compliance is key to producing data that meets FDA and EMA standards, which is vital for attracting investment and facilitating market entry. Moreover, the incorporation of ethical review processes under the new regulations enhances efficiency and participant safety, bolstering the region’s status as a competitive force in the global research landscape.

Grasping these dynamics is crucial for stakeholders aiming to leverage Latin America’s strategic benefits in early-stage research, particularly in the context of first in human trial Brazil. The integration of accelerated timelines, a strong regulatory system, and a diverse patient population establishes this nation as an ideal selection for early-stage clinical evaluations in the MedTech and Biopharma industries.

Navigate Regulatory Requirements for Clinical Trials

Successfully conducting first-in-human (FIH) studies hinges on a thorough understanding of the regulatory framework in this region. The first step is to submit a Clinical Trial Application (CTA) to ANVISA. This application must include a comprehensive Drug Clinical Development Dossier (DDCM), which consists of the study protocol, informed consent forms, and investigator qualifications. ANVISA is required to provide a written opinion within 45 calendar days, followed by a final decision within a maximum of 90 working days. Following ICH-GCP guidelines helps ensure that the approval process goes smoothly. Additionally, obtaining approval from local ethics committees (CEPs) is mandatory, as their endorsement is a prerequisite for ANVISA’s review. Understanding these regulatory requirements and timelines allows sponsors to prepare their submissions efficiently. This reduces the risk of delays that could hinder study initiation. The nation’s efficient procedures and dedication to regulatory adherence establish it as a key site for first in human trial Brazil, offering notable benefits in speed and cost-effectiveness. Understanding these processes not only streamlines approvals but also positions the nation as a premier destination for clinical research.

Implement Efficient Strategies for Accelerated Trial Execution

To accelerate trial execution in Latin America, sponsors must leverage the region’s unique advantages. Collaborating with established contract research organizations (CROs) is essential, as these partnerships provide invaluable insights into the local landscape. This collaboration enables quicker recruitment of participants and site selection. Local CROs excel at navigating Brazil’s regulatory environment, particularly with ANVISA, where approval timelines average 215 days – significantly longer than in many other regions. Working with these organizations allows sponsors to streamline submissions to ANVISA and CONEP. This ensures compliance with ICH-GCP standards and speeds up the approval process.

Furthermore, using technology for data management and monitoring can really boost operational efficiency. It enables real-time adjustments and enhances data integrity. Implementing adaptive design approaches allows for flexibility in response to interim results, potentially reducing the overall duration of the study. Conducting comprehensive feasibility evaluations before study initiation can uncover potential obstacles and enhance the recruitment process. It’s important to note that 40% of clinical studies in Brazil fail due to low participant enrollment. This issue can be alleviated through improved education and awareness strategies, which local CROs can assist in implementing.

By concentrating on these strategies, sponsors can significantly shorten timelines and lower costs, making their studies more competitive in the global landscape. The incorporation of local knowledge not only improves research efficiency but also establishes the region as a strategic center for early-stage studies. This leverages its diverse demographic and enhances access to treatment-naive groups. Utilizing insights from bioaccess’s Global Trial Accelerators™ can further enable MedTech and Biopharma innovators to effectively navigate the complexities of clinical studies in Latin America. By embracing these strategies, sponsors not only enhance their competitiveness but also position Latin America as a pivotal hub for clinical research.

Enhance Patient Recruitment and Engagement Strategies

Recruiting and engaging participants effectively is a pivotal factor in the success of first in human trial Brazil. To build trust within local communities, sponsors should work closely with healthcare providers and advocacy groups. Engaging local stakeholders not only enhances credibility but also facilitates smoother recruitment processes. Digital platforms can greatly enhance visibility and accessibility. This is especially true for younger populations who engage more with online content.

Tailoring recruitment messages to reflect cultural nuances and addressing potential barriers – such as language differences – can lead to higher enrollment rates. For instance, 24.1% of physicians observed a lack of research awareness among the population as a barrier to recruitment, emphasizing the necessity for targeted educational initiatives. Offering clear, accessible information about the research process and its potential advantages enables individuals to make informed choices regarding participation.

Additionally, the Brazilian research environment offers distinct benefits, such as quicker enrollment of participants and reduced expenses compared to conventional markets. With regulatory organizations like ANVISA optimizing approval procedures, sponsors can anticipate faster timelines for commencing studies. In fact, the Brazilian medical research participant recruitment services market is projected to reach USD 144.4 million by 2033, reflecting a strong demand for recruitment services. By addressing obstacles such as prolonged approval durations – many sponsors struggle with lengthy approval processes, which can delay recruitment efforts – and the limited number of accessible studies, sponsors can improve patient involvement and ensure a consistent influx of participants throughout the research, ultimately aiding the success of their medical research initiatives.

As one client pointed out, ‘Collaborating with bioaccess® enabled us to navigate the complexities of the Brazilian regulatory landscape efficiently, resulting in a successful launch ahead of schedule.’ This shows just how crucial it is to tap into local expertise and insights for better recruitment strategies. Bioaccess® is dedicated to leveraging these advantages, providing essential insights and strategies to accelerate clinical trials and market entry for MedTech and Biopharma companies in Latin America.

Conclusion

Brazil’s regulatory landscape presents both opportunities and challenges for first-in-human (FIH) trials, making it essential for sponsors to navigate it wisely. The recent regulatory reforms, particularly Law No. 14,874/2024, have significantly reduced approval timelines, making it an attractive option for sponsors looking to expedite their research and development processes. By capitalizing on Brazil’s unique advantages, stakeholders can enhance their clinical trial success rates while addressing the complexities of the local landscape.

Let’s explore some best practices that can make FIH trials in Brazil successful. Key strategies include:

• Collaborating with experienced contract research organizations (CROs) to facilitate smoother regulatory submissions and participant recruitment.
• Prioritizing compliance with ANVISA and ICH-GCP guidelines to ensure studies meet international standards, which is vital for attracting investment.
• Implementing targeted patient engagement strategies to significantly improve recruitment rates, addressing common barriers and enhancing overall trial efficiency.

In conclusion, Brazil’s evolving regulatory environment and its commitment to fostering a conducive research atmosphere position it as a strategic hub for early-stage clinical trials. By adopting the outlined best practices, sponsors can not only capitalize on the country’s advantages of speed and cost-effectiveness but also contribute to the advancement of medical research in Latin America. By embracing these strategies, sponsors not only enhance their trial outcomes but also play a pivotal role in shaping the future of healthcare in Latin America.

Frequently Asked Questions

What recent changes have impacted first-in-human trials in Brazil?

The enactment of Law No. 14,874/2024 has significantly reshaped the regulatory landscape for first-in-human trials in Brazil, reducing approval timelines from an average of 265 days to just 90 days.

How does Brazil’s patient population benefit first-in-human trials?

Brazil’s diverse and treatment-naive patient population provides a valuable resource for researchers conducting first-in-human trials, enhancing patient recruitment and the overall quality of clinical evaluations.

What role does ANVISA play in first-in-human trials in Brazil?

ANVISA, the Brazilian regulatory body, supervises research studies to ensure they conform to international standards such as ICH-GCP, which is essential for producing data that meets FDA and EMA standards.

What are the compliance requirements for conducting first-in-human trials in Brazil?

Compliance with international benchmarks like ICH-GCP is required, ensuring that research adheres to ethical standards and produces reliable data for market entry.

How does the new regulation enhance participant safety in clinical trials?

The incorporation of ethical review processes under the new regulations improves efficiency and participant safety, which is crucial for maintaining trust and integrity in clinical research.

Why is Brazil considered a competitive force in the global research landscape?

Brazil’s accelerated approval timelines, strong regulatory system, and diverse patient population establish it as an ideal location for early-stage clinical evaluations in the MedTech and Biopharma industries.

What strategic advantages does Latin America offer for early-stage clinical trials?

Latin America, particularly Brazil, offers speed in approval processes, cost efficiency, and effective patient recruitment, making it a strategic advantage for conducting early-stage clinical trials.

List of Sources

1. Understand the Landscape of First-in-Human Trials in Brazil
   • grandviewresearch.com (https://grandviewresearch.com/horizon/outlook/clinical-trials-market/brazil)
   • lickslegal.com (https://lickslegal.com/post/new-regulations-for-clinical-research-in-brazil)
   • statista.com (https://statista.com/statistics/1067453/brazil-number-clinical-trials-initiated?srsltid=AfmBOorNeHMRYCS3WQDds59a6Iv28RyooIach1XHknXX6qQftk0GdNwp)
   • lexology.com (https://lexology.com/library/detail.aspx?g=b1b655f4-963a-4be7-876c-81afb05caef6)
2. Navigate Regulatory Requirements for Clinical Trials
   • lickslegal.com (https://lickslegal.com/post/new-regulations-for-clinical-research-in-brazil)
   • credevo.com (https://credevo.com/articles/2019/03/14/clinical-trial-regulatory-process-brazil)
   • linkedin.com (https://linkedin.com/posts/cristiane-salles-36bbb336_clinicalresearch-brazil-clinicaltrials-activity-7434614266575560704-Kn4L)
   • linkedin.com (https://linkedin.com/posts/bioaccess_clinicaltrials-brazil-anvisa-activity-7447976698958106627-98MW)
   • bioaccessla.com (https://bioaccessla.com/blog/brazil-anvisa-parallel-review-clinical-trial-approvals-2026)
3. Implement Efficient Strategies for Accelerated Trial Execution
   • pmc.ncbi.nlm.nih.gov (https://pmc.ncbi.nlm.nih.gov/articles/PMC10898894)
   • pharmaphorum.com (https://pharmaphorum.com/views-and-analysis/accelerating-clinical-research-brazil)
   • lek.com (https://lek.com/insights/life-sciences-pharma/unlocking-brazils-clinical-trial-opportunity-strategic-roadmap)
4. Enhance Patient Recruitment and Engagement Strategies
   • pmc.ncbi.nlm.nih.gov (https://pmc.ncbi.nlm.nih.gov/articles/PMC10898894)
   • grandviewresearch.com (https://grandviewresearch.com/horizon/outlook/clinical-trial-patient-recruitment-services-market/brazil)
   • statista.com (https://statista.com/statistics/1067453/brazil-number-clinical-trials-initiated?srsltid=AfmBOopZcK_QgUFOSPSk-AkVnIixO9riFznsGp0hqgHHsDLIMGY9VpCC)

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Driven by a treatment-naive patient population and significant regulatory reforms, Brazil has rapidly positioned itself as a vital hub for clinical research. \n\nWith the recent changes in Law No. 14,874/2024, the approval process has been streamlined, offering sponsors a remarkable opportunity to expedite their clinical research endeavors. However, navigating Brazil’s evolving regulatory landscape can be daunting for stakeholders. \n\nHow can they effectively leverage Brazil’s unique advantages while overcoming the inherent challenges of patient recruitment and regulatory compliance? To succeed in early-stage clinical trials, stakeholders need to grasp these dynamics.\n\n## Understand the Landscape of First-in-Human Trials in Brazil\n\nBrazil has emerged as a pivotal hub for [first in human trial Brazil](https://bioaccessla.com/br) research, fueled by its diverse and treatment-naive patient population. The recent enactment of Law No. 14,874/2024 has reshaped the regulatory landscape significantly, [reducing approval timelines from an average of 265 days to just 90 days](https://lexology.com/library/detail.aspx?g=b1b655f4-963a-4be7-876c-81afb05caef6). This reform simplifies the process. It also enhances the country’s appeal for [first in human trial Brazil](https://bioaccessla.com/blog/10-key-insights-for-navigating-eu-medical-regulations-in-clinical-research). Consequently, sponsors can expedite their research and development initiatives.\n\nThe [Brazilian regulatory body, ANVISA](https://bioaccessla.com/blog/7-key-benefits-of-the-nci-n-87-for-clinical-research-success), plays a crucial role in supervising research studies, ensuring that they conform to international benchmarks such as [ICH-GCP](https://bioaccessla.com/br/services). This compliance is key to producing data that meets FDA and EMA standards, which is vital for [attracting investment and facilitating market entry](https://bioaccessla.com/blog/10-benefits-of-clinical-trial-remote-monitoring-for-research-directors). Moreover, the incorporation of ethical review processes under the new regulations enhances efficiency and participant safety, bolstering the region’s status as a competitive force in the global research landscape.\n\nGrasping these dynamics is crucial for stakeholders aiming to leverage Latin America’s strategic benefits in early-stage research, particularly in the context of first in human trial Brazil. The integration of accelerated timelines, a strong regulatory system, and a diverse patient population establishes this nation as an ideal selection for [early-stage clinical evaluations](https://bioaccessla.com/br/solutions) in the MedTech and Biopharma industries.\n\n\n\n## Navigate Regulatory Requirements for Clinical Trials\n\nSuccessfully conducting [first-in-human (FIH) studies](https://bioaccessla.com/solutions) hinges on a thorough understanding of the [regulatory framework](https://bioaccessla.com/market-access) in this region. The first step is to submit a [Clinical Trial Application (CTA)](https://credevo.com/articles/2019/03/14/clinical-trial-regulatory-process-brazil) to ANVISA. This application must include a comprehensive [Drug Clinical Development Dossier (DDCM)](https://bioaccessla.com/blog/10-essential-edc-software-features-for-clinical-research-directors), which consists of the study protocol, informed consent forms, and investigator qualifications. ANVISA is required to provide a written opinion within 45 calendar days, followed by a final decision within a maximum of 90 working days. Following [ICH-GCP guidelines](https://credevo.com/articles/2019/03/14/clinical-trial-regulatory-process-brazil) helps ensure that the approval process goes smoothly. Additionally, obtaining approval from local ethics committees (CEPs) is mandatory, as their endorsement is a prerequisite for ANVISA’s review. Understanding these [regulatory requirements and timelines](https://bioaccessla.com/blog/10-essential-steps-for-effective-medical-device-risk-management) allows sponsors to prepare their submissions efficiently. This reduces the risk of delays that could hinder study initiation. The nation’s efficient procedures and dedication to regulatory adherence establish it as a key site for [first in human trial Brazil](https://bioaccessla.com/blog/master-gcp-audit-planning-and-execution-under-malmed-framework), offering notable benefits in speed and cost-effectiveness. Understanding these processes not only streamlines approvals but also positions the nation as a premier destination for [clinical research](https://bioaccessla.com/testimonials).\n\n\n\n## Implement Efficient Strategies for Accelerated Trial Execution\n\nTo accelerate trial execution in Latin America, sponsors must leverage the region’s unique advantages. Collaborating with established [contract research organizations](https://bioaccessla.com/about) (CROs) is essential, as these partnerships provide invaluable insights into the local landscape. This collaboration enables quicker recruitment of participants and site selection. [Local CROs excel at navigating](https://bioaccessla.com/blog/10-clinical-trial-solutions-to-accelerate-research-success) [Brazil’s regulatory environment](https://lek.com/insights/life-sciences-pharma/unlocking-brazils-clinical-trial-opportunity-strategic-roadmap), particularly with ANVISA, where [approval timelines average 215 days](https://bioaccessla.com/blog/7-software-clinical-trials-solutions-to-streamline-research) – significantly longer than in many other regions. Working with these organizations allows sponsors to streamline submissions to ANVISA and CONEP. This ensures compliance with [ICH-GCP standards](https://bioaccessla.com/faq) and speeds up the approval process.\n\nFurthermore, using technology for data management and monitoring can really boost operational efficiency. It enables real-time adjustments and enhances data integrity. Implementing adaptive design approaches allows for flexibility in response to interim results, potentially reducing the overall duration of the study. Conducting comprehensive feasibility evaluations before study initiation can uncover potential obstacles and enhance the recruitment process. It’s important to note that 40% of [clinical studies in Brazil](https://bioaccessla.com/news/tag/Clinical+research+in+Latin+America) fail due to low participant enrollment. This issue can be alleviated through improved education and awareness strategies, which local CROs can assist in implementing.\n\nBy concentrating on these strategies, sponsors can significantly shorten timelines and lower costs, making their studies more competitive in the global landscape. The incorporation of local knowledge not only improves research efficiency but also establishes the region as a strategic center for early-stage studies. This leverages its diverse demographic and enhances access to treatment-naive groups. Utilizing insights from bioaccess’s Global Trial Accelerators™ can further enable MedTech and Biopharma innovators to effectively navigate the complexities of clinical studies in Latin America. By embracing these strategies, sponsors not only enhance their competitiveness but also position Latin America as a pivotal hub for clinical research.\n\n\n\n## Enhance Patient Recruitment and Engagement Strategies\n\nRecruiting and engaging participants effectively is a pivotal factor in the success of [first in human trial Brazil](https://bioaccessla.com/latin-america-medtech-research-site-search-and-selection). To build trust within local communities, sponsors should work closely with healthcare providers and advocacy groups. Engaging local stakeholders not only enhances credibility but also facilitates smoother recruitment processes. Digital platforms can greatly enhance visibility and accessibility. This is especially true for younger populations who engage more with online content.\n\nTailoring recruitment messages to reflect cultural nuances and addressing potential barriers – such as language differences – can lead to higher enrollment rates. For instance, 24.1% of physicians observed a lack of research awareness among the population as a barrier to recruitment, emphasizing the necessity for [targeted educational initiatives](https://pmc.ncbi.nlm.nih.gov/articles/PMC10898894). Offering clear, accessible information about the research process and its potential advantages enables individuals to make informed choices regarding participation.\n\nAdditionally, the Brazilian research environment offers distinct benefits, such as quicker enrollment of participants and reduced expenses compared to conventional markets. With regulatory organizations like ANVISA optimizing approval procedures, sponsors can anticipate faster timelines for commencing studies. In fact, the [Brazilian medical research participant recruitment services market](https://grandviewresearch.com/horizon/outlook/clinical-trial-patient-recruitment-services-market/brazil) is projected to reach USD 144.4 million by 2033, reflecting a strong demand for recruitment services. By addressing obstacles such as [prolonged approval durations](https://clinicaltrialsarena.com/marketdata/brazil-accounts-for-1-7-share-of-global-clinical-trial-activity-in-2021) – many sponsors struggle with lengthy approval processes, which can delay recruitment efforts – and the limited number of accessible studies, sponsors can improve patient involvement and ensure a consistent influx of participants throughout the research, ultimately aiding the success of their medical research initiatives.\n\nAs one client pointed out, ‘Collaborating with bioaccess® enabled us to navigate the complexities of the [Brazilian regulatory landscape](https://bioaccessla.com/news/globalcare-clinical-trials-chooses-bioaccess-to-expand-its-ambulatory-services-to-colombia) efficiently, resulting in a successful launch ahead of schedule.’ This shows just how crucial it is to tap into [local expertise and insights](https://bioaccessla.com/blog/7-steps-for-creating-so-ps-for-site-monitoring-in-serbia) for better recruitment strategies. Bioaccess® is dedicated to leveraging these advantages, providing essential insights and strategies to accelerate [clinical trials and market entry for MedTech and Biopharma companies in Latin America](https://bioaccessla.com/es/services).\n\n\n\n## Conclusion\nBrazil’s regulatory landscape presents both opportunities and challenges for first-in-human (FIH) trials, making it essential for sponsors to navigate it wisely. The recent regulatory reforms, particularly Law No. 14,874/2024, have significantly reduced approval timelines, making it an attractive option for sponsors looking to expedite their research and development processes. By capitalizing on Brazil’s unique advantages, stakeholders can enhance their clinical trial success rates while addressing the complexities of the local landscape. \n\nLet’s explore some best practices that can make FIH trials in Brazil successful. Key strategies include: \n\n- Collaborating with experienced contract research organizations (CROs) to facilitate smoother regulatory submissions and participant recruitment. \n- Prioritizing compliance with ANVISA and ICH-GCP guidelines to ensure studies meet international standards, which is vital for attracting investment. \n- Implementing targeted patient engagement strategies to significantly improve recruitment rates, addressing common barriers and enhancing overall trial efficiency. \n\nIn conclusion, Brazil’s evolving regulatory environment and its commitment to fostering a conducive research atmosphere position it as a strategic hub for early-stage clinical trials. By adopting the outlined best practices, sponsors can not only capitalize on the country’s advantages of speed and cost-effectiveness but also contribute to the advancement of medical research in Latin America. By embracing these strategies, sponsors not only enhance their trial outcomes but also play a pivotal role in shaping the future of healthcare in Latin America.\n\n::iframe[https://iframe.tely.ai/cta/eyJhcnRpY2xlX2lkIjogIjY5ZWZmYTg2YzA0MzJlMjBiMjgwM2VlYyIsICJjb21wYW55X2lkIjogIjY2OTk4NmYwMzM1YWQwNDI3ZTVmNTdlMyIsICJpbmRleCI6IG51bGwsICJ0eXBlIjogImFydGljbGUifQ==]{width=\”100%\” height=\”300px\”}”, “image”: [“https://images.tely.ai/telyai/qtrkuegf-this-flowchart-illustrates-the-key-components-of-first-in-human-trials-in-brazil-start-at-the-top-with-the-main-topic-then-follow-the-arrows-to-see-how-regulatory-changes-the-role-of-anvisa-and-benefits-for-stakeholders-are-interconnected-each-section-highlights-important-aspects-that-contribute-to-brazils-position-in-early-stage-clinical-research.webp”, “https://images.tely.ai/telyai/ouzafhcg-this-flowchart-outlines-the-steps-needed-to-navigate-regulatory-requirements-for-clinical-trials-start-with-submitting-your-application-then-follow-the-arrows-to-see-what-documents-you-need-and-the-timelines-for-anvis-as-review-and-final-decision-dont-forget-to-get-approval-from-local-ethics-committees.webp”, “https://images.tely.ai/telyai/sbdiicyn-this-flowchart-outlines-the-key-strategies-for-speeding-up-clinical-trials-in-latin-america-each-box-represents-a-strategy-and-the-arrows-show-how-they-connect-to-improve-trial-execution-follow-the-flow-to-see-how-each-step-contributes-to-a-more-efficient-process.webp”, “https://images.tely.ai/telyai/mwbrzjnm-the-central-idea-is-about-enhancing-recruitment-strategies-each-branch-represents-a-key-area-of-focus-and-the-sub-branches-provide-specific-actions-or-insights-related-to-that-area-this-layout-helps-visualize-how-different-strategies-connect-and-contribute-to-the-overall-goal.webp”], “inLanguage”: “en”, “author”: {“@type”: “Organization”, “name”: “bioaccess®”}, “publisher”: {“@type”: “Organization”, “name”: “bioaccess®”, “url”: “https://bioaccessla.com”}}