As global clinical trials become more competitive and data-driven, Latin America is stepping up with a new global standard in clinical trial quality. In this episode, Etienne Nichols speaks with Julio Martinez-Clark, CEO of BioAccess and a key advocate for clinical site certification in Latin America.

They discuss the launch of the GCSA certification and IAOCR accreditation now available in the Americas, exploring how these standards improve site credibility, de-risk clinical trials, and offer faster pathways for medtech market access. From regulatory advantages to site selection strategies, this episode is essential listening for sponsors, CROs, and MedTech leaders navigating global trials.

Key Timestamps

00:02 – Introduction to Julio Martinez-Clark and episode overview

02:10 – What is GCSA and IAOCR certification?

06:00 – Why certification is emerging now: volume, complexity, and patient safety

09:42 – Certification structure: site vs. individual requirements

13:45 – The Colombian model: First mover in Latin America

17:55 – Global harmonization vs. local certification pitfalls

21:30 – Measuring ROI of certified vs. non-certified sites

26:15 – Future of global site certification and Latin America’s role

30:00 – Regional differences: speed vs. patient pool in trial site selection

36:15 – Final thoughts on FDA trends and LATAM’s emerging position

Quotes

“It’s appalling that in an industry that deals with lives, there was no global standard to certify site or individual competency—until now.”

– Julio Martinez-Clark

Why it matters: This underscores the critical gap in clinical research infrastructure and the urgent need for standards like GCSA.

“You can’t measure quality without a shared framework. Certification levels the playing field globally.”

– Julio Martinez-Clark

Why it matters: This highlights how global certification allows consistent benchmarking across clinical sites, benefitting sponsors and patients alike.

Key Takeaways

GCSA Certification Elevates Site Credibility: Clinical sites with GCSA certification are fast-tracked for sponsor consideration, leading to better trial access and more robust patient recruitment.
IAOCR Accreditation Validates Individual Competency: For investigators, coordinators, and site managers, individual accreditation under the UNESCO-backed IAOCR framework offers a portable, verifiable skillset.
Latin America Offers Dual Advantages: With rapid recruitment and cost-effective data generation, LATAM is uniquely positioned to lead in globally certified trials—especially Colombia, which already mandates certification.
Global Harmonization is Critical: Fragmented local certifications can deter sponsors. A unified global framework like GCSA simplifies compliance, increases efficiency, and builds trust.
The FDA Bottleneck May Shift Market Entry: With regulatory delays in the U.S., more medtech firms may turn to Latin America for first-in-human trials and initial commercialization.

References

MedTech 101: What Is GCSA Certification?

Analogy: Think of GCSA like ISO 9001, but for clinical research sites. It standardizes operational quality and ensures consistent patient safety practices across global locations.

Beginner Example: If a sponsor is choosing between two hospitals, and one has a GCSA badge—it’s like choosing a restaurant with a food safety grade. It builds immediate trust.

Poll Question:

What’s your biggest challenge when selecting global clinical trial sites?

Assessing quality
Regulatory alignment
Patient recruitment speed
Cost
All of the above

Engagement Prompt:

Have you worked with certified sites or accredited professionals in your clinical trials? Share your experiences or questions with us at podcast@greenlight.guru.

Feedback

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Sponsor Message

This episode is brought to you by Greenlight Guru, the only MedTech Lifecycle Excellence Platform designed to accelerate product development and ensure clinical compliance. Learn more at www.greenlight.guru.

Lawrence Busch, “Standards: Recipes for Reality” (MIT Press, 2011)