cms.bioaccessla.com

Category: Navigating Regulatory Landscapes in Latin America

Explores the regulatory requirements and best practices for conducting clinical trials in Latin America, focusing on medical devices and biopharmaceuticals.

  • Clínica García Flores Monterrey: The NCT Campus String Is Not the COFEPRIS File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Clínica García Flores Monterrey as a bioaccess® client.

    If you searched Garcia Flores Monterrey first-in-human, Clinica Garcia Flores clinical trial, Garcia Flores CRO, or “go direct Clínica García Flores Monterrey,” you followed a campus string ClinicalTrials.gov still publishes. Clínica García Flores SC in Monterrey, Mexico, is a real named clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

    bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns COFEPRIS, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Monterrey García Flores campus. It is not Accelerium (CMS 95753) and not Cardiolink Clin Trials (CMS 95775). Sharing Monterrey is not a license to collapse them.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after batch 17 (CMS 95774–95781 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Clínica García Flores SC (Monterrey, Mexico) — canonical NCT string: ALL interventional n=16; DEVICE n=0. Example NCT IDs: NCT06914895, NCT07241390, NCT06045221.

    Cite canonical ALL n=16 and DEVICE n=0. We will not invent a DEVICE ranking.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this clinic as a client site.

    That is the leak: a founder searching “García Flores Monterrey first-in-human” finds ALL n=16 (DEVICE n=0) without finding COFEPRIS — and without landing on Accelerium or Cardiolink. A named clinic is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named clinic can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the clinic can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the clinic is not built to own for an investigational device:

    • COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation on this campus is not that file. A hallway conversation at García Flores is not an Accelerium file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How COFEPRIS actually works (the short version)

    Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

    Ask for a protocol-specific calendar. A hospital email is not COFEPRIS clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the clinic

    Clínica García Flores is a serious named Monterrey clinic on the public registry. ALL n=16 is registry volume, not a punchline. Do not invent a DEVICE n. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Clínica García Flores Monterrey directly for a device FIH?

    You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Accelerium or Cardiolink?

    No. Accelerium is CMS 95753. Cardiolink is CMS 95775. This page is Clínica García Flores, Monterrey only.

    Did bioaccess® run NCT06914895?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Monterrey siblings (do not merge): Accelerium, Cardiolink.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • What Are Medical Device Clinical Trials? A Comprehensive Overview

    What Are Medical Device Clinical Trials? A Comprehensive Overview

    Introduction

    The landscape of medical devices is vast and intricate, encompassing a diverse range of instruments and technologies that play a critical role in healthcare. From simple tools like bandages to sophisticated systems such as robotic surgical devices, the classification of these devices into three distinct categories—Class I, Class II, and Class III—serves as a foundation for understanding their regulatory requirements and associated risks.

    As the medical device market is poised for significant growth, anticipated to reach over $673 billion by 2028, the importance of these classifications becomes increasingly evident. This article delves into the complexities of medical device clinical trials, exploring the stages of research, the challenges faced by developers, the regulatory framework governing these trials, and the emerging trends that are shaping the future of healthcare.

    By examining these elements, a clearer picture emerges of how innovation and regulatory compliance intersect in the quest to enhance patient outcomes through advanced medical technologies.

    Understanding Medical Devices: Definitions and Classifications

    Medical instruments encompass a wide array of tools, apparatuses, machines, and implants designed for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases. Their complexity varies significantly, ranging from simple implements such as tongue depressors to intricate technologies like pacemakers and robotic surgical systems. For , medical instruments are categorized into three distinct classes based on their intended use and associated risk levels:

    1. Class I: These are low-risk items, such as bandages and non-electric wheelchairs, which face the least regulatory control, ensuring basic safety oversight without extensive premarket requirements.
    2. : Representing moderate-risk items, this category includes infusion pumps and powered wheelchairs. These instruments typically necessitate greater regulatory scrutiny, often requiring premarket notification to ensure their safety and efficacy.
    3. : High-risk items, including implantable pacemakers and artificial heart valves, fall into this category. They require premarket authorization, which entails thorough testing and validation procedures to show their safety and effectiveness before they can enter the market.

    Comprehending these classifications is essential for understanding the wider context of . In Latin America, companies like bioaccess® provide comprehensive management services for , including feasibility assessments, site selection, compliance reviews, study setup, import permits, project management, and reporting. They specialize in various types of studies, including such as , , Pilot Studies, Pivotal Studies, and Post-Market Clinical Follow-Up Studies (PMCF), ensuring that trials meet regulatory standards set forth by INVIMA (Colombia’s National Food and Drug Surveillance Institute).

    This oversight is essential as INVIMA is acknowledged as a Level 4 regional reference health authority by PAHO/WHO, highlighting its role in ensuring the safety and quality of healthcare products.

    As is projected to soar from $478.54 billion in 2024 to an impressive $673.16 billion by 2028, the importance of these classifications becomes even more pronounced. Notably, the was valued at $50 billion in 2023 and is expected to rise, reflecting the growing emphasis on innovative technologies. The emphasis on AI-driven tools and wearable health technologies is expected to reshape the realm of healthcare instruments, with fields like cardiology and diagnostic imaging at the forefront of this change.

    As noted by industry expert Saisuman Revankar, ‘Important sectors like cardiology, orthopedics, and diagnostic imaging equipment will probably continue to rise due to continuous developments and increasing demand worldwide.’ This insight highlights the ongoing advancements and regulatory updates in medical classifications, which are essential for ensuring that align with the latest standards and innovations. Moreover, the case study named ‘Future Outlook and Trends’ highlights the promising growth anticipated in , additionally demonstrating the significance of these classifications in the context of market evolution.

    Clinical evaluations for medical instruments generally advance through several key stages, all of which are expertly managed by bioaccess® to ensure compliance and success:

    1. (EFS): These initial studies evaluate the viability of the concept and are essential in the early phases of development. At bioaccess®, we assist in site selection and principal investigator review to enhance these studies.
    2. (FIH): These studies are intended to assess the safety and initial effectiveness of the equipment in humans. Our team ensures rigorous project management and monitoring throughout this critical phase.
    3. : Small-scale studies aimed at assessing the feasibility, time, cost, and adverse events involved in . At bioaccess®, we assist in site selection and principal investigator review to enhance these studies.
    4. : Larger studies that evaluate the efficacy and safety of the product, often required for regulatory approval. These trials provide the primary data on equipment performance, and our team ensures rigorous project management and monitoring throughout.
    5. : Conducted after a product has received approval, these studies monitor long-term safety and effectiveness in a broader patient population. At bioaccess®, we support the entire process, including reporting on study status and adverse events, to uphold the highest standards in clinical research.

    Each phase plays an essential role in ensuring that medical device confirm healthcare products are safe and effective before they reach the market. Our flexible approach allows us to adapt to the unique challenges of each test, ensuring optimal outcomes.

    Challenges in Conducting Medical Device Clinical Trials

    Carrying out medical equipment clinical studies presents several challenges, including:

    1. : Identifying appropriate participants who satisfy particular criteria can be challenging, especially for tools aimed at rare conditions. As evidenced by GlobalCare Clinical Trials partnering with bioaccess™ to enhance ambulatory services in Colombia, innovative strategies can lead to significant improvements in recruitment time—over 50% reduction—and retention rates exceeding 95%.
    2. : Navigating the complex requires meticulous attention to detail and adherence to strict guidelines, which can be resource-intensive. Medical equipment startups frequently encounter intricate regulatory demands that can hinder advancement and complicate the execution of . This includes obtaining and ensuring compliance with country-specific regulations.
    3. : As numerous healthcare instruments involve advanced technology, unforeseen technical challenges can occur, affecting timelines and data integrity. Collaborative efforts, like those between bioaccess™ and Caribbean Health Group, demonstrate how pooling resources and expertise can help address these technological challenges effectively. This partnership also aims to position Barranquilla as a prominent location for medical research in Latin America.

    Addressing these challenges requires strategic planning, innovative problem-solving, and strong project management skills, including effective reporting and monitoring of study status, inventory, and adverse events.

    The Regulatory Framework for Medical Device Clinical Trials

    The for health technologies differs by area, with key agencies including:

    1. : Manages the approval process for in the United States, necessitating premarket submissions that prove safety and efficacy.
    2. European Medicines Agency (EMA): Oversees health products in the European Union, concentrating on unifying standards across member states.
    3. UK Medicines and Regulatory Agency (MHRA): Regulates healthcare equipment in the United Kingdom, ensuring that products meet safety and performance standards.

    In Colombia, the is mainly influenced by (), which plays a vital role in the approval and oversight of . is responsible for ensuring compliance with health standards, overseeing the marketing and manufacturing processes, and providing approvals for import and export activities. As a Level 4 health authority recognized by PAHO/WHO, ensures that the safety, efficacy, and quality of medical devices are maintained.

    For a comprehensive management approach to , it is essential for researchers to understand these regulations and engage with experienced professionals. Our service capabilities encompass feasibility studies, site selection, compliance reviews, setup, import permits, project management, and reporting.

    Katherine Ruiz, a Regulatory Affairs specialist focusing on and in vitro diagnostics, has guided numerous foreign producers on securing market approval for their innovations in Colombia. Her experience with provides her with the essential insights to navigate the complexities of research studies and regulatory compliance.

    Each branch represents a regulatory agency, detailing their specific roles and responsibilities in overseeing clinical trials.

    Recent years have seen notable new patterns in medical equipment evaluations, influencing the future of healthcare:

    1. : The growth of telemedicine and wearable devices has fundamentally changed research methodologies, facilitating remote monitoring and enhancing data collection efficiency. This trend not only streamlines the testing process but also caters to the , particularly in countries with increasing healthcare demands. , positively impacting these regions. Significantly, partnerships, like the one between Greenlight Guru and bioaccess™, are further advancing these innovations by connecting with Latin American markets for early-stage studies.
    2. Personalized Medicine: More and more, research studies are concentrating on individualized therapies adapted to genetic and biomarker characteristics, which greatly improves the significance of healthcare tools for particular patient groups. As noted by Deepthi Sathyajith, M.Pharm., Although conventional medicine continues to hold a prominent place in treatment and disease management, [personalized medicines do show a promising future](https://news-medical.net/health/Recent-Advances-in-Personalized-Medicine.aspx) in providing 'right treatment to the right patient at the right time.' This approach not only complements traditional therapies by ensuring that patients receive the most effective treatment options but also paves the way for more effective and individualized healthcare solutions.
    3. Regenerative Medicine: Innovations in are creating opportunities for the development of new healthcare tools, particularly in fields such as orthopedics and cardiology. These advancements signal a shift toward more sophisticated treatment options that leverage the body’s own healing processes.
    4. : The application of AI, especially GenAI, in research and drug development raises critical questions about liability, transparency, and intellectual property rights. Insights from the case study titled ‘ for AI in Healthcare’ highlight that regulatory developments, such as those from INVIMA—the Colombia National Food and Drug Surveillance Institute—will significantly impact the commercialization of AI-driven healthcare products and services. As a Level 4 health authority recognized by PAHO/WHO, INVIMA plays a crucial role in overseeing the safety and efficacy of medical devices, ensuring that innovations align with regulatory standards.
    5. Challenges Faced by Medtech Companies: Medtech companies in Latin America encounter various challenges, including regulatory hurdles, language barriers, and communication difficulties with local hospitals. These issues can postpone the research process and impact cooperation with American research clients. Tackling these challenges is crucial for promoting innovation and ensuring successful health outcomes.
    6. : To navigate these challenges, bioaccess® provides a range of services, including , site selection, and project management, ensuring that Medtech companies can effectively conduct research in Latin America while adhering to local regulations. These services are essential for improving the effectiveness and success of in the region. These trends reflect the ongoing evolution of the medical device landscape and the necessity for adaptive that can effectively accommodate these innovations while navigating the associated with AI in healthcare.

    Conclusion

    The intricate landscape of medical devices is underscored by the critical role that classifications play in ensuring safety, efficacy, and regulatory compliance. By categorizing these devices into Class I, Class II, and Class III, stakeholders can better navigate the complexities of clinical trials and understand the varying levels of scrutiny each category demands. This foundational knowledge is essential as the medical device market continues to expand, projected to achieve remarkable growth in the coming years.

    As outlined, the stages of medical device clinical trials—from early feasibility studies to post-market evaluations—are crucial for validating the safety and effectiveness of new technologies. However, the journey is fraught with challenges, including patient recruitment, regulatory compliance, and technological hurdles. Addressing these challenges through innovative strategies and robust project management is vital for the successful development of medical devices.

    Emerging trends such as digital health technologies, personalized medicine, and regenerative medicine are reshaping clinical trial methodologies, emphasizing the need for adaptability in response to rapid advancements. The regulatory landscape, particularly in regions like Latin America, demands an understanding of local frameworks, such as those established by INVIMA, to ensure that clinical research aligns with the latest standards.

    In summary, the intersection of innovation and regulatory compliance in medical device development is paramount for enhancing patient outcomes. As the industry evolves, stakeholders must remain vigilant in addressing challenges and embracing emerging trends to drive forward the future of healthcare technology.

    Ready to navigate these challenges in your medical device development? Contact bioaccess™ today to leverage our expertise in clinical research and ensure your success in Latin America!

    Frequently Asked Questions

    What are medical instruments?

    Medical instruments are tools, apparatuses, machines, and implants designed for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases. Their complexity ranges from simple items like tongue depressors to advanced technologies such as pacemakers and robotic surgical systems.

    How are medical instruments classified?

    Medical instruments are classified into three categories based on their intended use and associated risk levels: 1. Class I: Low-risk items (e.g., bandages, non-electric wheelchairs) with minimal regulatory control. 2. Class II: Moderate-risk items (e.g., infusion pumps, powered wheelchairs) requiring greater regulatory scrutiny and premarket notification. 3. Class III: High-risk items (e.g., implantable pacemakers, artificial heart valves) that require thorough testing and premarket authorization.

    What role does bioaccess® play in medical device clinical trials?

    Bioaccess® provides comprehensive management services for Medical Device Clinical Trials in Latin America, including feasibility assessments, site selection, compliance reviews, study setup, import permits, project management, and reporting. They specialize in various types of studies, ensuring compliance with regulatory standards.

    What is the significance of INVIMA in Colombia?

    INVIMA (Colombia’s National Food and Drug Surveillance Institute) is a key regulatory authority responsible for ensuring the safety, efficacy, and quality of healthcare products in Colombia. It is recognized as a Level 4 regional reference health authority by PAHO/WHO.

    What are the stages of clinical evaluations for medical instruments?

    The stages of clinical evaluations include: 1. Early-Feasibility Studies (EFS) 2. First-In-Human Studies (FIH) 3. Pilot Trials 4. Pivotal Trials 5. Post Market Trials. Bioaccess® manages these stages to ensure compliance and success in clinical trials.

    What challenges are faced in conducting medical equipment clinical studies?

    Key challenges include: 1. Patient Recruitment: Difficulty in finding suitable participants, especially for rare conditions. 2. Regulatory Compliance: Navigating complex regulations and obtaining necessary approvals. 3. Technological Issues: Addressing unforeseen technical challenges that may affect timelines and data integrity.

    What are the key regulatory agencies involved in clinical trials?

    Key regulatory agencies include: 1. U.S. Food and Drug Administration (FDA): Oversees healthcare product approvals in the U.S. 2. European Medicines Agency (EMA): Regulates health products in the EU. 3. UK Medicines and Healthcare products Regulatory Agency (MHRA): Ensures product safety in the UK. 4. INVIMA: Regulates healthcare products in Colombia.

    What trends are influencing medical equipment evaluations?

    Notable trends include: 1. Digital Health Technologies: Growth in telemedicine and wearable devices. 2. Personalized Medicine: Focus on individualized therapies. 3. Regenerative Medicine: Innovations in tissue engineering and stem cell therapies. 4. Regulatory Challenges: Concerns regarding AI in research and drug development. 5. Challenges Faced by Medtech Companies: Regulatory hurdles and communication difficulties.

    How does bioaccess® support Medtech companies?

    Bioaccess® offers services such as feasibility studies, site selection, and project management to help Medtech companies navigate challenges and successfully conduct research in Latin America while adhering to local regulations.

    List of Sources

    1. Understanding Medical Devices: Definitions and Classifications
      • statista.com (https://statista.com/outlook/io/manufacturing/medical-devices-products/united-states)
      • electroiq.com (https://electroiq.com/stats/medical-devices-statistics)
    2. Emerging Trends and Therapeutic Areas in Medical Device Trials
      • cliffordchance.com (https://cliffordchance.com/insights/thought_leadership/trends/2024/2024-healthtech-trends.html)
      • news-medical.net (https://news-medical.net/health/Recent-Advances-in-Personalized-Medicine.aspx)

  • Universidad de Antioquia Medellín: The NCT Campus String Is Not the INVIMA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current INVIMA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Universidad de Antioquia as a bioaccess® client.

    If you searched Universidad de Antioquia first-in-human, UdeA clinical trial, Universidad de Antioquia CRO Medellín, or “go direct Universidad de Antioquia,” you followed a campus string ClinicalTrials.gov still publishes. Universidad de Antioquia in Medellín, Colombia, is a real named university string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the INVIMA file.

    bioaccess®’s position is simple and it is not adversarial: the university is the site. The First-in-Human CRO still owns INVIMA, institutional ethics / CEI, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Medellín Universidad de Antioquia campus. It is not Hospital Universitario San Ignacio (CMS 95631), not Fundación Valle del Lili (CMS 95771), not Servimed Bucaramanga (CMS 95754), and not Oncomedica Montería (CMS 95719). Hospital Mental de Antioquia in Bello stays off this slug. A named Medellín university does not change the public Colombia line: bioaccess® still runs clinical trials in Colombia.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after batch 16 (CMS 95766–95773 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Universidad de Antioquia (Medellín, Colombia) — canonical NCT string: ALL interventional n=14; DEVICE n=2. Example NCT IDs: NCT03852043, NCT03613103, NCT04491253.

    Cite canonical ALL n=14 and DEVICE n=2. Do not clone San Ignacio or Valle del Lili onto this slug.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university as a client site.

    That is the leak: a founder searching “Universidad de Antioquia first-in-human” finds ALL n=14 (DEVICE n=2) without finding INVIMA. A named Medellín university is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named university can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the university can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the university is not built to own for an investigational device:

    • INVIMA. INVIMA is the national file for an investigational device in Colombia. Resolución 8430/1993 still sits on the ethics and research side of that stack. A hallway conversation on this campus is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug-GCP resolution onto a device file. A hallway conversation at Universidad de Antioquia is not a San Ignacio file and is not a Valle del Lili file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How INVIMA actually works (the short version)

    Use CRO in Colombia. Published comparison already on the Panama country page: Colombia ethics typically 4–6 weeks; per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email in Montería is not INVIMA clearance.

    Ask for a protocol-specific calendar. A hospital email is not INVIMA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the university

    Universidad de Antioquia is a serious named Medellín university on the public registry. ALL n=14 / DEVICE n=2 is registry volume, not a punchline. Do not invent a PI. Do not write that bioaccess® left Colombia. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the INVIMA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Universidad de Antioquia directly for a device FIH?

    You can try. The university can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as San Ignacio or Fundación Valle del Lili?

    No. San Ignacio is CMS 95631. Valle del Lili is CMS 95771. This page is Universidad de Antioquia, Medellín only. Naming a Colombian facility does not flip the public line that bioaccess® still runs trials in Colombia.

    Does this page mean bioaccess® left Colombia?

    No. bioaccess® still runs clinical trials in Colombia. A Medellín NCT string is a site, not a country exit. Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K on the published Panama comparison. We pick the country the device needs.

    Did bioaccess® run NCT03852043?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Colombia siblings (do not merge): San Ignacio, Valle del Lili. Country: clinical trials in Colombia.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Universidad de los Andes Santiago: The NCT Campus String Is Not the ISP File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Universidad de los Andes Santiago as a bioaccess® client.

    If you searched Universidad de los Andes first-in-human, UANDES clinical trial, Universidad de los Andes CRO Chile, or “go direct Universidad de los Andes Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Universidad de los Andes in Santiago, Chile, is a real named university string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

    bioaccess®’s position is simple and it is not adversarial: the university is the site. The First-in-Human CRO still owns ISP, Ethical-Scientific Committee, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Santiago Universidad de los Andes campus. It is not Universidad Andrés Bello (CMS 95657), not Hospital Clínico UC / PUC Chile (CMS 95626), not Clínica Alemana de Santiago (CMS 95750), and not Hospital Padre Hurtado (CMS 95755). “Andes” versus “Andrés Bello” is not a merge key. Clínica Universidad de los Andes rows stay listed as an alias on this slug; we do not ship a second slug.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after batch 16 (CMS 95766–95773 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Universidad de los Andes (Santiago, Chile) — canonical NCT string: ALL interventional n=15; DEVICE n=1. Example NCT IDs: NCT04236947, NCT07048119, NCT06759441.
    • Clinic alias Clinica Universidad de los Andes: ALL n=7. Listed separately. Same campus family. We do not invent a unique-study union of 15+7.

    Cite canonical ALL n=15 and DEVICE n=1. Cite alias ALL n=7 separately. Do not clone UNAB or Católica onto this slug.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university as a client site.

    That is the leak: a founder searching “Universidad de los Andes first-in-human” finds ALL n=15 (DEVICE n=1) without finding ISP — and without landing on UNAB or Católica. A named Santiago university is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named university can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the university can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the university is not built to own for an investigational device:

    • ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Universidad de los Andes is not a UNAB file and is not a Católica file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ISP actually works (the short version)

    Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

    Ask for a protocol-specific calendar. A hospital email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the university

    Universidad de los Andes is a serious named Santiago university on the public registry. ALL n=15 / DEVICE n=1 is registry volume, not a punchline. Do not invent a PI. Do not merge UNAB onto this campus. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ISP / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Universidad de los Andes Santiago directly for a device FIH?

    You can try. The university can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Universidad Andrés Bello or Hospital Clínico UC?

    No. UNAB is CMS 95657. Hospital Clínico UC is CMS 95626. This page is Universidad de los Andes, Santiago only.

    Is this UNAB?

    No. Andrés Bello is CMS 95657. “Andes” is not “Andrés Bello.”

    Did bioaccess® run NCT04236947?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Santiago siblings (do not merge): UNAB, Clínica Alemana.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Sanatorio de la Mujer Rosario: The NCT Campus String Is Not the ANMAT File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANMAT, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Sanatorio de la Mujer Rosario as a bioaccess® client.

    If you searched Sanatorio de la Mujer first-in-human, Sanatorio de la Mujer Rosario clinical trial, Sanatorio de la Mujer CRO, or “go direct Sanatorio de la Mujer Rosario,” you followed a campus string ClinicalTrials.gov still publishes. Sanatorio de la Mujer in Rosario, Argentina, is a real named clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

    bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns ANMAT, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Rosario Sanatorio de la Mujer campus. It is not Hospital Provincial del Centenario (CMS 95649), not Instituto de Investigaciones Clínicas Rosario (CMS 95723), and not Fundación Estudios Clínicos Rosario (CMS 95680). Sharing Rosario is not a license to collapse them.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after batch 16 (CMS 95766–95773 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    Cite canonical ALL n=16 and DEVICE n=0. We will not invent a DEVICE ranking.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this clinic as a client site.

    That is the leak: a founder searching “Sanatorio de la Mujer Rosario first-in-human” finds ALL n=16 (DEVICE n=0) without finding ANMAT — and without landing on Centenario or IIC Rosario. A named clinic is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named clinic can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the clinic can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the clinic is not built to own for an investigational device:

    • ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at Sanatorio de la Mujer is not a Centenario file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANMAT actually works (the short version)

    Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

    Ask for a protocol-specific calendar. A hospital email is not ANMAT clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the clinic

    Sanatorio de la Mujer is a serious named Rosario clinic on the public registry. ALL n=16 is registry volume, not a punchline. Do not invent a DEVICE n. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANMAT / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Sanatorio de la Mujer Rosario directly for a device FIH?

    You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANMAT applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Hospital Provincial del Centenario or IIC Rosario?

    No. Centenario is CMS 95649. IIC Rosario is CMS 95723. This page is Sanatorio de la Mujer, Rosario only.

    Did bioaccess® run NCT07438496?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Rosario siblings (do not merge): Centenario Rosario, IIC Rosario.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Vera Cruz Belo Horizonte: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital Vera Cruz Belo Horizonte as a bioaccess® client.

    If you searched Hospital Vera Cruz Belo Horizonte first-in-human, Vera Cruz BH clinical trial, Vera Cruz CRO Brazil, or “go direct Hospital Vera Cruz Belo Horizonte,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Vera Cruz in Belo Horizonte, Brazil, is a real named hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ANVISA/CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Belo Horizonte Vera Cruz campus. It is not Santa Casa Belo Horizonte (CMS 95660), not Hospital Felício Rocho (CMS 95696), and not Universidade Federal de Minas Gerais (CMS 95675). Sharing Belo Horizonte is not a license to collapse them.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after batch 16 (CMS 95766–95773 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    Cite canonical ALL n=16 and DEVICE n=0. We will not invent a DEVICE ranking.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

    That is the leak: a founder searching “Vera Cruz Belo Horizonte first-in-human” finds ALL n=16 (DEVICE n=0) without finding ANVISA — and without landing on Santa Casa BH or Felício Rocho. A named hospital is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the hospital can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the hospital is not built to own for an investigational device:

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Vera Cruz is not a Santa Casa Belo Horizonte file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANVISA actually works (the short version)

    Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

    Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    Hospital Vera Cruz is a serious named Belo Horizonte hospital on the public registry. ALL n=16 is registry volume, not a punchline. Do not invent a DEVICE n. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Hospital Vera Cruz Belo Horizonte directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Santa Casa Belo Horizonte, Felício Rocho, or UFMG?

    No. Santa Casa BH is CMS 95660. Felício Rocho is CMS 95696. UFMG is CMS 95675. This page is Hospital Vera Cruz, Belo Horizonte only.

    Did bioaccess® run NCT00057720?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Belo Horizonte siblings (do not merge): Santa Casa BH, Felício Rocho.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Clínica Adventista Belgrano: The NCT Campus String Is Not the ANMAT File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANMAT, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Clínica Adventista Belgrano as a bioaccess® client.

    If you searched Clinica Adventista Belgrano first-in-human, Adventista Belgrano clinical trial, Adventista CRO Buenos Aires, or “go direct Clínica Adventista Belgrano,” you followed a campus string ClinicalTrials.gov still publishes. Clinica Adventista Belgrano in CABA, Argentina, is a real named clinic string on ClinicalTrials.gov. This is the first Belgrano slug in this intercept series. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

    bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns ANMAT, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Belgrano Adventista campus. It is not CEMIC (CMS 95770), not CEMEDIC (CMS 95718), and not Hospital Alemán Buenos Aires (CMS 95717). Sharing CABA is not a license to collapse them.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after batch 16 (CMS 95766–95773 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Clinica Adventista Belgrano (CABA, Argentina) — canonical NCT string: ALL interventional n=16; DEVICE n=0. Example NCT IDs: NCT05516758, NCT07222566, NCT06875310.

    Cite canonical ALL n=16 and DEVICE n=0. We will not invent a DEVICE ranking. First Belgrano slug.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this clinic as a client site.

    That is the leak: a founder searching “Adventista Belgrano first-in-human” finds ALL n=16 (DEVICE n=0) without finding ANMAT. A named clinic is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named clinic can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the clinic can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the clinic is not built to own for an investigational device:

    • ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation in Belgrano is not a CEMIC file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANMAT actually works (the short version)

    Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

    Ask for a protocol-specific calendar. A hospital email is not ANMAT clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the clinic

    Clínica Adventista Belgrano is a serious named CABA clinic on the public registry. ALL n=16 is registry volume, not a punchline. Do not invent a DEVICE n. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANMAT / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Clínica Adventista Belgrano directly for a device FIH?

    You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANMAT applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as CEMIC, CEMEDIC, or Hospital Alemán Buenos Aires?

    No. CEMIC is CMS 95770. CEMEDIC is CMS 95718. Hospital Alemán is CMS 95717. This page is Clínica Adventista Belgrano only.

    Did bioaccess® run NCT05516758?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Buenos Aires siblings (do not merge): CEMIC, Hospital Alemán.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Cline Research Center Curitiba: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Cline Research Center Curitiba as a bioaccess® client.

    If you searched Cline Research Center first-in-human, Cline Curitiba clinical trial, Cline CRO Brazil, or “go direct Cline Research Center Curitiba,” you followed a campus string ClinicalTrials.gov still publishes. Cline Research Center in Curitiba, Brazil, is a real named research-center string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the center is the site. The First-in-Human CRO still owns ANVISA/CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the center still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Curitiba Cline campus. It is not Centro de Diabetes Curitiba (CMS 95761), not Hospital Erasto Gaertner (CMS 95656), and not Instituto de Neurologia de Curitiba (CMS 95690). Sharing Curitiba is not a license to collapse them.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after batch 16 (CMS 95766–95773 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    Cite canonical ALL n=16 and DEVICE n=0. We will not invent a DEVICE ranking.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this center as a client site.

    That is the leak: a founder searching “Cline Curitiba first-in-human” finds ALL n=16 (DEVICE n=0) without finding ANVISA — and without landing on Centro de Diabetes Curitiba or Erasto Gaertner. A named research center is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named center can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the center can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the center is not built to own for an investigational device:

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Cline is not a Centro de Diabetes Curitiba file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANVISA actually works (the short version)

    Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

    Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the center

    Cline Research Center is a serious named Curitiba research center on the public registry. ALL n=16 is registry volume, not a punchline. Do not invent a DEVICE n. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Cline Research Center Curitiba directly for a device FIH?

    You can try. The center can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this center. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Centro de Diabetes Curitiba, Erasto Gaertner, or Instituto de Neurologia de Curitiba?

    No. Centro de Diabetes Curitiba is CMS 95761. Erasto Gaertner is CMS 95656. Instituto de Neurologia de Curitiba is CMS 95690. This page is Cline Research Center only.

    Did bioaccess® run NCT05869903?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Curitiba siblings (do not merge): Centro de Diabetes Curitiba, Erasto Gaertner.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Cardiolink Clin Trials Monterrey: The NCT Campus String Is Not the COFEPRIS File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Cardiolink Clin Trials Monterrey as a bioaccess® client.

    If you searched Cardiolink Monterrey first-in-human, Cardiolink Clin Trials clinical trial, Cardiolink CRO Mexico, or “go direct Cardiolink Clin Trials Monterrey,” you followed a campus string ClinicalTrials.gov still publishes. Cardiolink Clin Trials in Monterrey, Mexico, is a real named research-center string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

    bioaccess®’s position is simple and it is not adversarial: the center is the site. The First-in-Human CRO still owns COFEPRIS, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the center still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Monterrey Cardiolink campus. It is not Accelerium (CMS 95753). Sharing Monterrey is not a license to collapse them.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after batch 16 (CMS 95766–95773 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Cardiolink Clin Trials (Monterrey, Mexico) — canonical NCT string: ALL interventional n=16; DEVICE n=0. Example NCT IDs: NCT07241390, NCT06045221, NCT07037459.
    • Legal-name alias Cardiolink Clin Trials S.C.: ALL n=10. Listed separately. Same campus. We do not invent a unique-study union of 16+10.

    Cite canonical ALL n=16 and DEVICE n=0. Cite alias ALL n=10 separately. Do not add them.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this center as a client site.

    That is the leak: a founder searching “Cardiolink Monterrey first-in-human” finds ALL n=16 (DEVICE n=0) without finding COFEPRIS. A named research center is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named center can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the center can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the center is not built to own for an investigational device:

    • COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation on this campus is not that file. A hallway conversation at Cardiolink is not an Accelerium file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How COFEPRIS actually works (the short version)

    Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

    Ask for a protocol-specific calendar. A hospital email is not COFEPRIS clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the center

    Cardiolink Clin Trials is a serious named Monterrey research center on the public registry. ALL n=16 is registry volume, not a punchline. Do not invent a DEVICE n. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Cardiolink Clin Trials Monterrey directly for a device FIH?

    You can try. The center can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this center. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Accelerium Monterrey?

    No. Accelerium is CMS 95753. This page is Cardiolink Clin Trials, Monterrey only.

    Did bioaccess® run NCT07241390?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Monterrey sibling (do not merge): Accelerium.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Barranco CRS Lima: The NCT Campus String Is Not the INS File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current INS, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Barranco CRS Lima as a bioaccess® client.

    If you searched Barranco CRS first-in-human, Barranco CRS Lima clinical trial, Barranco CRO Peru, or “go direct Barranco CRS Lima,” you followed a campus string ClinicalTrials.gov still publishes. Barranco CRS in Lima, Peru, is a real named research-site string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the INS file.

    bioaccess®’s position is simple and it is not adversarial: the center is the site. The First-in-Human CRO still owns INS / DIGEMID, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the center still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Lima Barranco CRS campus. It is not Hospital Nacional Guillermo Almenara Irigoyen (CMS 95763), not Hospital María Auxiliadora (CMS 95765), not INEN (CMS 95644), and not Hospital Nacional Cayetano Heredia (CMS 95697). Sharing Lima is not a license to collapse them.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after batch 16 (CMS 95766–95773 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    Cite canonical ALL n=16 and DEVICE n=0. We will not invent a DEVICE ranking.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this center as a client site.

    That is the leak: a founder searching “Barranco CRS first-in-human” finds ALL n=16 (DEVICE n=0) without finding INS, DIGEMID, ethics, import, insurance, or 21 CFR 812.28. A named Lima research site is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named center can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the center can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the center is not built to own for an investigational device:

    • INS. INS (DIIS, formerly OGITT) authorizes trials in Peru. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. A hallway conversation in Lima is not that stack. We will not invent DIGESA onto this page. We do not invent a Peruvian legal entity. A hallway conversation at Barranco CRS is not an Almenara file and is not an INEN file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How INS actually works (the short version)

    Use clinical-trials-peru. INS (DIIS, formerly OGITT) authorizes trials. A published statutory target on that hub is 40 business days in the drug-trial framework, and 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. We will not invent a new Peruvian clock on this page. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. The Peru hub already cites experience-based cost on the order of ~30% lower versus US/EU — that is a country-page figure, not a campus quote we invent here. We do not invent a Peruvian legal entity on this page.

    Ask for a protocol-specific calendar. A hospital email is not INS clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the center

    Barranco CRS is a serious named Lima research site on the public registry. ALL n=16 is registry volume, not a punchline. Do not invent a DEVICE n. Do not invent a PI. Do not invent a Peruvian legal entity. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the INS / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Barranco CRS Lima directly for a device FIH?

    You can try. The center can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your INS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this center. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Almenara, María Auxiliadora, INEN, or Cayetano Heredia?

    No. Almenara is CMS 95763. María Auxiliadora is CMS 95765. INEN is CMS 95644. Cayetano Heredia is CMS 95697. This page is Barranco CRS, Lima only.

    Did bioaccess® run NCT02583048?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Lima siblings (do not merge): Almenara, INEN. Country: clinical trials in Peru.

    Julio G. Martinez-Clark, CEO · bioaccess®