---
title: "US + Latin America Cardiovascular Trial Site Strategy | Amavita Research"
url: https://md.amavitaresearch.com/blog/us-latin-america-cardiovascular-trial-site-strategy
canonical: https://www.amavitaresearch.com/blog/us-latin-america-cardiovascular-trial-site-strategy
schema_type: Article
last_updated: 2026-05-13
---

# US + Latin America Cardiovascular Trial Site Strategy

A sponsor strategy guide for hybrid cardiovascular trial designs that combine a U.S. arm with a Latin America first-in-human arm under a single coordinated protocol.

## Why hybrid US + LATAM designs work for cardiovascular trials

For early-feasibility cardiovascular device studies, Latin America offers faster regulatory pathways (INVIMA in Colombia, ANVISA in Brazil) and lower per-patient cost than the U.S. for the FIH cohort. The U.S. arm provides the regulatory anchor for FDA submission and the patient population needed for IDE/IND filing or expansion cohorts.

## The integrated model

- **U.S. arm** at Amavita Research — Miami, single PI, walk-in cardiology flow, ICH-GCP E6(R3) compliant
- **Latin America arm** at bioaccess® — Colombia and regional markets, first-in-human CRO operations, INVIMA-experienced regulatory team

Both organizations share leadership (Julio G. Martinez-Clark is CEO of both bioaccess® and serves as Head of Growth & Strategy at Amavita Research), which means protocol coordination, data harmonization, and sponsor communication run through a single counterpart.

## When this design wins

- Early-feasibility cardiovascular device studies (5–20 patient FIH cohort in LATAM, U.S. expansion cohort thereafter)
- Phase 1 / Phase 2a drug studies where Latin America regulatory speed matters
- Studies needing geographic diversity for FDA Diversity Action Plan (DAP) compliance
- Sponsors with U.S. headquarters who want a single English-language counterpart for both arms
- Studies where IRB and ethics committee coordination across two countries needs a single point of contact

## When this design doesn't fit

- Phase 3 pivotal trials requiring high U.S. enrollment volume (use U.S.-only or multi-site U.S. network)
- Indications where FDA prefers U.S.-generated data (consult sponsor regulatory affairs)
- Sponsor procurement requires a single-country contracting model

## Operational mechanics

- Single integrated protocol document — both sites operate under the same protocol with country-specific addenda
- Harmonized eCRF and central data management
- Coordinated SAE reporting to both FDA and INVIMA / ANVISA
- Single sponsor PM counterpart at the bioaccess®/Amavita Research interface
- IRB approval at U.S. site (typically central) + ethics committee at LATAM site

## Discussion contact

- Sponsor contact: https://www.amavitaresearch.com/contact-sponsor
- Trial services: https://www.amavitaresearch.com/trial-services
- Site capabilities: https://www.amavitaresearch.com/capabilities
- bioaccess® (sister organization): https://www.bioaccessla.com