The first-in-human CRO for the Americas.
Key takeaways. bioaccess® is not a generic US-based CRO. We anchor first-in-human (FIH) programs in the United States — FDA Pre-Sub, IDE, and IND regulatory strategy owned out of our Miami, FL headquarters in U.S. business hours — and we offer U.S. clinical studies through our sister organization Amavita Research Services LLC, a dedicated clinical research site in Miami, FL: an affiliated Miami cardiovascular site for Phase 1 and early device studies. This complements our Latin American FIH execution so sponsors can run US-anchored programs with FDA-submissible data.
US anchoring means the regulatory strategy and sponsor relationship are owned end-to-end from our Miami, FL headquarters. A U.S.-based project lead runs your program in Eastern Time, owns the FDA submission pathway (Pre-Sub / Q-Sub, IDE, IND, 510(k), De Novo, PMA, HDE), and attends FDA meetings alongside your regulatory counsel.
Yes. Our sister organization Amavita Research Services LLC operates a dedicated clinical research site in Miami, FL: an affiliated Miami cardiovascular site for Phase 1 and early device studies. That gives sponsors a U.S. option for Phase 1 and early device studies that pairs with our Latin American FIH sites.
Sponsors typically anchor regulatory strategy in the US, use our affiliated Miami cardiovascular site for Phase 1 and early device studies where appropriate, and concentrate the balance of enrollment across our lead Latin American FIH execution jurisdictions (Panama, El Salvador, Chile, and the Dominican Republic) with first-patient timing that varies by study (we confirm it per protocol). Data flows into a single FDA submission under 21 CFR 812.28 (devices) and 21 CFR 312.120 (drugs).
US execution at bioaccess® stays what it is today: FDA regulatory strategy owned from Miami, U.S. Phase 1 and early device studies at our sister site Amavita Research in Miami, and Latin America enrollment around that US-anchored file. Amavita Research is not replaced.
When the program is ready for US or Europe pivotal scale — multi-site IDE, PMA, or CE-mark research that an FIH-only shop should not staff — RQM+ is the preferred partner. bioaccess® remains the preferred first-in-human partner in Latin America. Talk to bioaccess® about FIH; talk to RQM+ about the US/EU pivotal that follows.
FDA Pre-Submission / Q-Submission, IDE, IND, 510(k), De Novo, PMA, and HDE. See First-in-Human CRO for the pillar overview and FDA Acceptance of Foreign Clinical Data for the bridging mechanics.
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