---
title: "Sister Organization: bioaccess® — Latin America First-in-Human CRO | Amavita Research"
url: https://md.amavitaresearch.com/sister-organization-bioaccess
canonical: https://www.amavitaresearch.com/sister-organization-bioaccess
schema_type: WebPage
last_updated: 2026-05-13
---

# Sister Organization: bioaccess® — Latin America First-in-Human CRO

Integrated US + Latin America cardiovascular trial designs, anchored on bioaccess®'s 50+ delivered FIH programs since 2010.

Amavita Research and bioaccess® are sister organizations. Amavita Research is the U.S. cardiovascular clinical trial site (Miami, FL); bioaccess® is the Latin America first-in-human CRO operating across 10 Latin American markets. Both organizations share leadership — Julio G. Martinez-Clark is CEO of bioaccess® and Head of Growth & Strategy at Amavita Research; Dr. Pedro Martinez-Clark and Dr. William W. O'Neill co-founded bioaccess® and hold leadership roles at Amavita Research.

## bioaccess® at a glance

- **Founded:** 2010
- **Founders:** Dr. Pedro Martinez-Clark, MD (Harvard Medical School); Dr. William W. O'Neill, MD (MSCAI)
- **CEO:** Julio G. Martinez-Clark, MBA
- **Headquarters:** 1200 Brickell Ave., Suite 1950 #1034, Miami, FL 33131, USA
- **Clients served:** 50+ since founding (out of hundreds consulted)
- **Pre-qualified sites:** 50+ across Latin America
- **Markets:** Colombia, Brazil, Mexico, Argentina, Chile, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay
- **Service model:** U.S. regulatory anchoring (FDA Pre-Sub, IND/IDE) + Latin American execution
- **Audience:** MedTech, Biopharma, and Radiopharma startups

## Published bioaccess® FIH client outcomes

These 4 clients are publicly disclosed on bioaccessla.com/first-in-human-cro. The outcomes were delivered by bioaccess® (the sister organization), not by Amavita Research directly:

- **Axoft** — 4 brain-computer interface implants in 2.5 years; seed-stage to clinical
- **Newrotex** — world's first silk nerve guide human implant; 2-week regulatory approval
- **PAVmed** — CarpX™ device; FDA Breakthrough Device Designation using Latin American clinical data
- **Avantec Vascular** — Sangria™ venous remodeling system; FIH completed in El Salvador

## Why this integration matters for Amavita Research sponsors

- **Hybrid US + Latin America trial designs** — Run a Phase 1 / FIH cohort in Latin America via bioaccess® and an expansion or follow-on cohort at Amavita Research's Phase 1 unit in Miami. Single integrated protocol, harmonized eCRF, coordinated SAE reporting.
- **Single sponsor counterpart** — Both arms operate through one coordinated team rather than two separate vendors.
- **Cost-efficient FIH cohort** — bioaccess® reports 40% faster timelines and 30% lower per-patient cost than US/EU for the Latin America arm.
- **FDA-bridgeable data** — bioaccess® executes ICH-GCP compliant trials at sites pre-qualified for FDA acceptance under 21 CFR 812.28.
- **Continuous patient flow on the US arm** — Amavita Research's in-network cardiology practice provides walk-in patient flow for the US expansion cohort.

## Regulatory coverage (bioaccess® LATAM)

- Colombia: INVIMA (Level 4 regulatory authority)
- Brazil: ANVISA
- Mexico: COFEPRIS (30-day approval pathway)
- Argentina: ANMAT
- Chile: ISP (ISO 13485 recognition)
- Panama: MINSA
- Ecuador: ARCSA
- El Salvador: DNM
- Dominican Republic: DIGEMAPS
- Paraguay: DINAVISA

## How to engage

1. Sponsor contacts Amavita Research with a protocol synopsis or full protocol
2. Internal feasibility review with both Amavita Research (US arm) and bioaccess® (LATAM arm) teams
3. Joint feasibility response within 5 business days for standard protocols
4. Joint sponsor call with both organizations' clinical leads
5. Single integrated CTA covering both arms (or separate contracts per sponsor preference)
6. Coordinated site initiation
7. First patient in — typically Latin America first (faster regulatory pathway), US arm activates per protocol

## Key links

- Amavita Research home: https://www.amavitaresearch.com/
- Phase 1 cardiovascular unit (Kendall): https://www.amavitaresearch.com/phase-1-unit
- Active trials: https://www.amavitaresearch.com/trials
- US + Latin America cardiovascular trial site strategy: https://www.amavitaresearch.com/blog/us-latin-america-cardiovascular-trial-site-strategy
- Sponsor contact: https://www.amavitaresearch.com/contact-sponsor
- bioaccess® main site: https://bioaccessla.com
- bioaccess® markdown mirror: https://md.bioaccessla.com