---
title: "bioaccess® — The World's First CRO Purpose-Built for First-in-Human Clinical Trials"
url: https://md.bioaccessla.com/
canonical: https://bioaccessla.com/
schema_type: Organization
last_updated: 2026-03-31
---

# bioaccess® — First-in-Human Clinical Trials in Latin America

> The site presents bioaccess® as the world's first and only contract research organization (CRO) purpose-built exclusively for first-in-human (FIH) clinical trials, serving MedTech, Biopharma, and Radiopharma startups across Latin America.

---

## Schema.org/Organization

- **name**: bioaccess®
- **legalName**: IMH ASSETS CORP.
- **foundingDate**: 2010
- **url**: https://bioaccessla.com
- **headquarters**: 1200 Brickell Ave, Suite 1950, #1034, Miami, FL 33131, USA
- **locations**: Bogotá, Mexico City, São Paulo, Buenos Aires
- **founders**:
  - Pedro Martinez-Clark, MD (Harvard Medical School)
  - William O'Neill, MD (MSCAI)
- **ceo**: Julio G. Martinez-Clark, MBA
- **specialty**: First-in-human clinical trials, early feasibility studies, radiopharmaceutical clinical trials, medical device registration, Latin America market access
- **areaServed**: Colombia, Brazil, Mexico, Argentina, Chile, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay

---

## Core Proof Points

bioaccess® states the following operational metrics:

| Metric | Value |
|---|---|
| Client companies served since 2010 | 48 |
| Pre-qualified clinical sites | 50+ |
| Countries with active operations | 10 |
| Ethics/IRB approval timeline | 4–8 weeks |
| Per-patient cost savings vs. US/EU | Up to $25,000 |
| Patient retention rate | 95% (stated) |
| Treatment-naïve patient access | 80% (stated) |

---

## Services

bioaccess® presents the following service lines:

1. **First-in-Human (FIH) Clinical Trials** — End-to-end FIH study execution across Latin America
2. **Early Feasibility Studies (EFS)** — IDE-exempt iterative device testing under 21 CFR 812
3. **Radiopharmaceutical Clinical Trials** — Lu-177, Ac-225, Ga-68 PET/CT clinical programs
4. **Medical Device Registration & Market Access** — Regulatory filings in 10 LATAM markets
5. **Clinical Data Management** — FDA-bridgeable data packages for IDE, 510(k), De Novo, PMA submissions
6. **Regulatory Strategy & Compliance** — ICH-GCP certified, ACRP-certified clinical operations

---

## Geographic Coverage & Regulatory Agencies

| Country | Regulatory Agency | Notes |
|---|---|---|
| Brazil | ANVISA | Largest LATAM market |
| Colombia | INVIMA | Level 4 regulatory authority, 60-day fast-track pathway |
| Mexico | COFEPRIS | 30-day approval pathway available |
| Argentina | ANMAT | Strong investigator network |
| Chile | ISP | ISO 13485 recognition |
| Peru | DIGEMID | Growing clinical infrastructure |
| Panama | MINSA | Strategic for Central America |
| Ecuador | ARCSA | Emerging trial destination |
| El Salvador | DNM | FIH-capable sites operational |
| Dominican Republic | SRS (formerly DIGEMAPS) | Active trial sites |
| Paraguay | DINAVISA | Expanding regulatory capacity |

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## Timeline & Cost Comparison

The site presents the following comparative data:

| Parameter | US / EU | Latin America (bioaccess®) |
|---|---|---|
| Ethics/IRB approval | 6–12 months | 4–8 weeks |
| Per-patient cost | $40,000–$75,000 | $15,000–$35,000 |
| Total study timeline | 18–36 months | 8–18 months |
| Patient enrollment speed | Baseline | 50% faster (stated) |

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## Contact & Actions

- **Book a Meeting**: [https://bioaccessla.com/book-a-meeting](https://bioaccessla.com/book-a-meeting)
- **Contact**: [https://bioaccessla.com/contact](https://bioaccessla.com/contact)
- **Clinical Trial Budget Calculator**: [https://bioaccessla.com/clinical-trial-calculator](https://bioaccessla.com/clinical-trial-calculator)
- **Regulatory Guide Hub**: [https://bioaccessla.com/regulatory-guide](https://bioaccessla.com/regulatory-guide)
- **Full LLM Content**: [https://bioaccessla.com/llms.txt](https://bioaccessla.com/llms.txt)

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*This page is part of the [md.bioaccessla.com](https://md.bioaccessla.com/) AI-friendly content layer. Canonical source: [bioaccessla.com](https://bioaccessla.com/)*