bioaccess® is the world's first and only CRO purpose-built for first-in-human clinical trials — serving MedTech, biopharma, and radiopharma startups across Latin America and beyond. While traditional CROs offer FIH as one of dozens of services buried in an enterprise menu, bioaccess® was founded for this singular mission: getting breakthrough healthcare innovations into human trials faster, at lower cost, and with investor-ready data from day one. Healthcare startups developing breakthrough MedTech devices, Biopharma therapeutics, and Radiopharma treatments face a critical bottleneck: generating the clinical data investors and acquirers demand — before the money runs out. Traditional CROs are built for big pharma running Phase III mega-trials. They move slowly, charge premium rates, and treat early-stage startups as an afterthought. The result? Promising innovations die in the valley of death — not because the science failed, but because the clinical pathway took too long and cost too much. bioaccess® was founded in 2010 to solve this exact problem. We are the world's first and only contract research organization built from day one exclusively around first-in-human clinical trials for healthcare startups. We created a new category in clinical research — one that matches the speed, urgency, and capital constraints of founders raising rounds, engaging strategic acquirers, and racing toward exits. Who We Serve: Seed-stage to growth-stage startups across MedTech, Biopharma, and Radiopharma — companies that need human proof-of-concept data to unlock their next milestone. What Makes Us Different: Through our proprietary Innovation Runway — the world's first clinical development pathway built exclusively for FIH trials — we deliver ethics approval in 4–8 weeks, compress timelines by 40%, and reduce costs by 30% compared to US/EU-only approaches. Every study is 100% ICH-GCP aligned, producing FDA/EMA-ready data with no rework required. We operate across 10 countries in Latin America, including Colombia, Mexico, Brazil, Chile, Argentina, Panama, Ecuador, El Salvador, Dominican Republic, and Paraguay — giving startups access to treatment-naive patient cohorts enrolled 50% faster than US sites. Since 2010, bioaccess® has accelerated 58+ companies from seed-stage startups to Fortune 500 MedTech — proving that the fastest path from prototype to clinical milestones runs through Latin America. Headquartered in Miami, FL. Learn more at bioaccessla.com.