# #414: Why Global Certification is the Future of Clinical Research in Latin America

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-07-07
- Length: 34m
- Episode: 414
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-07-414-why-global-certification-is-the-future-of-clinical-research-in-latin-america
- Listen: https://podcast.greenlight.guru/episode/414-clinical-research-certifications-and-what-it-means-for-your-trials

## Summary

Julio Martinez-Clark, CEO of BioAccess, explains the launch of GCSA site certification and IAOCR individual accreditation in Latin America, designed to standardize clinical trial quality and de-risk sponsor investments. He highlights Colombia’s 2008 mandate as a regional pioneer and discusses how these global standards create tiered site hierarchies that accelerate patient recruitment and data generation. Martinez-Clark argues that regulatory bottlenecks at the FDA and in Europe are driving medtech companies to prioritize Latin America for first-in-human trials and early commercialization. The conversation covers the strategic trade-offs between speed in smaller nations like Panama and patient pool depth in larger markets like Brazil and Mexico.

## Outline

1. Introduction: Julio Martinez-Clark and BioAccess
2. GCSA and IAOCR Certification Explained
3. Why Certification is Emerging Now: Volume and Complexity
4. The Colombian Model: First Mover in Latin America
5. Global Harmonization vs. Local Certification Pitfalls
6. Measuring ROI of Certified vs. Non-Certified Sites
7. Future of Global Site Certification and Latin America’s Role
8. Regional Differences: Speed vs. Patient Pool in Trial Site Selection
9. Final Thoughts on FDA Trends and LATAM’s Emerging Position

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Logistics & fulfilment](https://hardwarepodcasts.com/topic/logistics-and-fulfillment)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies

## Mentioned

- BioAccess (company)
- GCSA (other)
- IAOCR (other)
- UNESCO (other)
- Mayo Clinic (company)
- Velocity Research (company)
- FDA (other)
- Cofepris (other)

## Related episodes from other shows

- [058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban) (Let's Combinate)
- [038 - "Clinical Trials" with Dan Sfera](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera) (Let's Combinate)
- [195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-02-195-clinical-trial-design-oncology-innovation-decentralized-trials-with-archana) (Let's Combinate)

## Citing this page

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