Question 1

What clinical trial services does bioaccess® offer?

Accepted Answer

bioaccess® provides first-in-human (FIH) studies, early feasibility studies (EFS), and full-service clinical trial management for MedTech, Biopharma, and Radiopharma companies. Every program is anchored on U.S. regulatory strategy (FDA Pre-Sub, IND/IDE) and executed across Latin America — meaningfully faster and at lower cost than equivalent US or EU pathways.

Question 2

Which countries does bioaccess® run clinical trials in?

Accepted Answer

bioaccess® concentrates first-in-human clinical execution in lead FIH execution jurisdictions — Panama, El Salvador, Chile, and the Dominican Republic — and provides device registration and market access across 19 Latin American & Caribbean countries, with U.S. regulatory anchoring for FDA-accepted data.

Question 3

Does the FDA accept clinical data generated in Latin America?

Accepted Answer

Yes. The FDA accepts data from studies conducted outside the U.S. under 21 CFR 812.28 (medical devices) and 21 CFR 312.120 (drugs and biologics) when device studies meet ISO 14155 and drug/biologic studies meet ICH E6 GCP. bioaccess® designs every program to be FDA-acceptable from the outset.

Question 4

How much faster and cheaper are bioaccess® clinical trials?

Accepted Answer

bioaccess® programs are typically meaningfully faster and at lower cost than equivalent US or EU pathways, with first patient typically 4–8 months after protocol finalization and per-patient costs of $15,000–$35,000 versus $40,000–$75,000 in the US or EU.

First-in-human and early feasibility trials across the Americas

Service Offerings