First-in-Human Clinical Trials in Latin America, What MedTech Teams Need to Know Before They Expand

Expanding clinical research into Latin America can unlock faster enrollment, strong investigator networks, and real-world diversity—but only if MedTech teams understand the regulatory pathways, ethics approvals, operational realities, and site selection factors that make (or break) first-in-human execution. In this Friday In-Focus session, Julio G. Martinez-Clark (CEO, Bioaccess) breaks down what MedTech teams need to know before launching first-in-human clinical trials in Latin America—covering timelines, country differences, and practical strategies to reduce delay and increase study success. You’ll learn: • When Latin America is a strong fit for first-in-human trials (and when it is not) • Key regulatory and ethics approval workflows across major LATAM markets • How to select sites and investigators for speed, quality, and enrollment performance • Contracting, import/logistics, and operational pitfalls that cause avoidable delays • Data quality, monitoring strategy, and managing multi-country execution • How LATAM evidence can support global regulatory and commercialization strategy Speaker: • Julio G. Martinez-Clark — CEO, Bioaccess Replay and chapters below. 00:00 – Welcome & session goals: why LATAM for first-in-human trials 03:10 – LATAM advantages: timelines, enrollment, investigator experience 08:20 – Country landscape: where teams start and why 12:40 – Regulatory and ethics approvals: what actually drives timelines 18:10 – Site selection: choosing investigators, hospitals, and patient access 24:30 – Contracts, budgets, and startup operations that slow teams down 31:00 – Importation and logistics: devices, supplies, and customs realities 38:20 – Monitoring and data quality: what “good” looks like across sites 44:50 – Using LATAM evidence globally: strategy considerations 52:10 – Q&A 58:30 – Wrap-up & next steps