bioaccess® was co-founded in 2010 by Harvard Medical School-trained physician Dr. Pedro Martinez-Clark, renowned interventional cardiologist Dr. William O'Neill, and operator Julio G. Martinez-Clark. bioaccess® is The First-in-Human CRO — built for the U.S. and Latin America — anchoring on U.S. regulatory strategy (FDA Pre-Sub, IND/IDE) and executing across Latin America. 50+ client companies served since founding.
Investigative sites in the bioaccess® network have been inspected by the U.S. FDA and passed inspection. This describes individual sites, not an inspection or audit of bioaccess® itself; FDA acceptance of any given study's data is a case-by-case determination under 21 CFR 812.28. Staff, site, and study counts are experience-based estimates from programs since 2010, except the 19-country footprint, which is a defined list.
We built bioaccess® to do one thing the big CROs aren't structured for: get a startup's device or therapy safely into its first humans and produce data designed to support FDA review, subject to the agency's assessment of the submission. Since 2010 that focus — not Phase III scale — is why more than 50 companies have trusted us with their first-in-human milestone.
First-in-human work is where medical innovation actually begins. bioaccess® exists to give the next generation of device and therapy founders a disciplined, credible path to that first implant or first dose.