Question 1

Why choose bioaccess® over a full-service CRO for first-in-human trials?

Accepted Answer

bioaccess® is a CRO built exclusively for first-in-human trials, meaning every process, site, and team member is optimized for FIH. Full-service CROs treat FIH as a small slice of their portfolio. bioaccess® offers FIH-12™, its written protocol-to-LPLV timeline guarantee (full terms provided in the proposal), materially lower per-patient costs versus U.S. or E.U. programs, and high enrollment retention across 50+ startup clients since 2010.

Question 2

How does bioaccess® compare on cost versus US/EU CROs?

Accepted Answer

bioaccess® delivers first-in-human studies at $15,000–$35,000 per patient in Latin America, compared to $40,000–$75,000 in the US or EU. A 10-patient FIH study typically runs $300,000–$500,000 versus $750,000–$1.5M in the US — a 50–70% cost reduction while generating data under GCP-aligned controls (ISO 14155 for devices) intended to support an FDA submission under 21 CFR 812.28. FDA acceptance is determined on a submission-by-submission basis.

Question 3

Does bioaccess® work with pre-Series B startups?

Accepted Answer

Yes — the majority of bioaccess® clients are pre-Series B MedTech and Biopharma startups. bioaccess® offers flexible pricing structures, including risk-sharing arrangements, and has successfully completed FIH studies for companies later acquired by Edwards Lifesciences (Mitralign), Alcon (ClarVista Medical), and Allergan (ForSight VISION5).

FIH-12™ vs Full-Service CROs | Why Startups Choose bioaccess®

First-in-human destination intercepts

Named CRO comparisons