bioaccess®

bioaccess — The World's First CRO Purpose-Built for First-in-Human Clinical Trials

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.

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.

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.

Since 2010, bioaccess has accelerated 58+ companies from seed-stage startups to Fortune 500 MedTech.

Headquartered in Miami, FL. Learn more at bioaccessla.com.