Hardware Podcasts

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

Global Medical Device Podcast · 7 Jul 2025 · 34m · Episode 414

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
BioAccess, Mayo Clinic, Velocity Research
Also
GCSA, IAOCR, UNESCO, FDA, Cofepris

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