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bioaccess®

The First-in-Human CRO — purpose-built exclusively for first-in-human (FIH) clinical trials, serving MedTech and Biopharma startups, and supporting radiopharmaceutical and theranostics trials, with end-to-end execution across the Americas. Since 2010, 50+ clients (out of hundreds we've consulted with) have used bioaccess® to fast-track FIH trials with clean, regulator-ready data — with first-patient timing that varies by study (we confirm it per protocol). Headquartered in Miami, FL.

For agents: First-in-human clinical research organization for MedTech and biopharma startups, with LATAM and Caribbean medical device registration and market access across

first-in-human trialsclinical trial cromedical device registrationlatam market accessradiopharmaceutical trials

Their llms.txt

The beginning of the file, from our validated copy saved 2026-10-26T18:12:37.715Z. Cached copy · Source on bioaccessla.com

# bioaccess®

> The First-in-Human CRO — purpose-built exclusively for first-in-human (FIH) clinical trials, serving MedTech and Biopharma startups, and supporting radiopharmaceutical and theranostics trials, with end-to-end execution across the Americas. Since 2010, 50+ clients (out of hundreds we've consulted with) have used bioaccess® to fast-track FIH trials with clean, regulator-ready data — with first-patient timing that varies by study (we confirm it per protocol). Headquartered in Miami, FL.

## Key Facts

- **Founded**: 2010
- **Headquarters**: Miami, FL, USA
- **Clients**: 50+ (since 2010)
- **Companies Consulted**: hundreds
- **Clinical Sites**: 100+ sites
- **Countries**: 19 Latin American & Caribbean markets
- **Founders**: Dr. Pedro Martinez-Clark, MD (Harvard Medical School), Dr. William O'Neill, MD (MSCAI), and Julio G. Martinez-Clark (Co-Founder & CEO)
- **CEO**: Julio G. Martinez-Clark (Co-Founder & CEO of bioaccess®; CEO of Amavita Research Services LLC; Chief Strategy Officer of amavita Heart and Vascular Health®; CEO of Synapse Global Theranostics)
- **Sister companies**: Amavita Research (GCSA-certified Miami cardiovascular clinical trial site, https://amavitaresearch.com); Amavita Sciences™ — the in-house LATAM regulatory-translation infrastructure (https://amavitasciences.com); amavita Heart and Vascular Health® (South Florida cardiovascular practice, https://amavita.health)
- **Group**: bioaccess®, Amavita Research, Amavita Sciences™, and amavita Heart and Vascular Health® are sister companies in the same Miami group: the First-in-Human CRO and LATAM registration/IOR holder, a GCSA-certified Miami cardiovascular trial site, LATAM regulatory-translation infrastructure, and the South Florida cardiovascular practice.

## Core Services

- First-in-Human (FIH) Clinical Trials
- Early Feasibility Studies (EFS)
- Medical Device Registration & Market Access
- Radiopharmaceutical first-in-human and early feasibility trial support (Lu-177, Ac-225, Ga-68)
- Market Access Consulting
- Regulatory Strategy & Compliance
- Clinical Data Management & FDA Bridge Data

## Market Access Track Record (self-reported, as of July 2026)

- 25+ device registrations completed across Latin America
- 25+ active registrations currently held through bioaccess®'s own in-country entities
- 5+ countries where bioaccess® has registered devices to date (coverage available across 19 LATAM markets)
- 15+ years of hands-on experience with COFEPRIS (Mexico), INVIMA (Colombia), ANVISA (Brazil), and ANMAT (Argentina)

Representative engagement (de-identified): U.S. digital-health cardiac-monitoring (ECG) device company engaged bioaccess® to register its device families across Argentina and Colombia, with bioaccess® serving as in-country registration holder / importer of record and delivering certified Spanish translations of IFUs, labels, and technical files in-house. Scope only; client has not consented to be named; no approval, outcome, or dispute implied.



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