For Sponsors
FIH in Latin America + expansion in Miami
The integrated Americas model: run first-in-human in Latin America via bioaccess®, expand at our GCSA-certified Miami site — coordinated through one team and one BD contact.
Why sponsors split FIH and expansion geographically
First-in-human studies and later-phase expansion cohorts place different demands on a trial operation. FIH needs specialized Phase 1 units, intensive safety monitoring, and rapid protocol iteration. Expansion needs broad enrollment, diverse patient populations, and pivotal-trial infrastructure.
Sponsors have long run these phases in different geographies to match each phase to the setting where it executes best — FIH where specialized units and startup speed are strongest, expansion where the regulatory and enrollment profile fits the pivotal program.
The friction has always been coordination: two vendors, two contracts, two study-management teams, and knowledge lost in the handoff between phases. The integrated Americas model removes that friction by running both phases under one coordinated team.
Phase 1 — Latin America
The LATAM FIH case
bioaccess®, our sister organization, is a first-in-human CRO operating across the Americas — 50+ delivered FIH programs since 2010, with 15+ years of operating experience in the region.
Latin America offers experienced Phase 1 units, competitive cost structures, and startup timelines that keep early-phase programs moving — with regulatory pathways built for early-phase research.
Expansion — Miami
Why Miami for expansion
When the program moves to expansion, Amavita Research's Miami site brings the profile a pivotal program needs: GCSA certification (recertified May 2026), a TAVR-pioneer senior PI in Dr. William W. O'Neill, and one of the most diverse enrollment populations in the United States — natively aligned with FDA Diversity Action Plan expectations for Phase 3 trials.
Our dedicated cardiovascular ambulatory surgery center supports interventional and device protocols in a controlled outpatient setting, and our PIs recruit from a continuously-enrolling cardiology practice — not a referral network.
How the integrated model works
Single BD contact
Julio G. Martinez-Clark, CEO — julio@amavita.health — is the first touch, CDA, and NDA contact for both the FIH and expansion phases.
Coordinated feasibility & contracting
Feasibility and contracting run in parallel across both geographies — one process, not two vendor negotiations.
One study-management team
A single team carries the program from FIH through expansion — no knowledge lost in a vendor handoff between phases.
FAQ
Questions about the integrated model
Next step
Talk to Amavita Research about your FIH program
One BD contact. Same-business-day response. FIH in Latin America, expansion in Miami — coordinated as one program.