For Sponsors
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. The integrated relationship lets sponsors design hybrid US + Latin America trial programs under a single coordinated counterpart.
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
The following are publicly-disclosed bioaccess® client deliveries (as stated by bioaccess® on bioaccessla.com/first-in-human-cro). These outcomes were delivered by bioaccess®, not by Amavita Research directly.
| Sponsor | Outcome (as stated by bioaccess®) |
|---|---|
| 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 matters for Amavita Research sponsors
- Hybrid US + Latin America trial designs — Run a Phase 1 / first-in-human 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 (foreign clinical study data for IDE submissions).
- Continuous patient flow on the US arm — Amavita Research's in-network cardiology practice (amavita Heart and Vascular Health®) provides walk-in patient flow for the US expansion cohort.
Regulatory coverage
bioaccess® works with the following Latin American regulators:
- 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
- Sponsor contacts Amavita Research with a protocol synopsis or full protocol
- Internal feasibility review with both Amavita Research (US arm) and bioaccess® (LATAM arm) teams
- Joint feasibility response within 5 business days for standard protocols
- Joint sponsor call with both organizations' clinical leads
- Single integrated CTA covering both arms (or separate contracts per sponsor preference)
- Coordinated site initiation
- First patient in — typically Latin America first (faster regulatory pathway), US arm activates per protocol