Early Feasibility Studies in Latin America

Global Medical Device Podcast · 8 Jun 2022 · 42m · Episode 266

What this episode covers

Julio Martinez-Clark, CEO and co-founder of BioAccess, explains why Colombia is an ideal destination for early feasibility studies (EFS) and first-in-human clinical trials for US medtech companies. He details how Colombia offers cost-effective, ethical, and high-quality sites, addressing the immense struggle US companies face with patient recruitment and expensive, slow FDA processes. Martinez-Clark highlights Colombia's regulatory predictability, cultural similarities, and unique GCP certification process, while noting challenges like language barriers and the need for Spanish translation of regulatory documents.

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