Jul 7
34m 49s
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.
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
“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.