How bioaccess® as a specialized LatAm CRO achieves sub-12-month FIH dosing with Argentina, Chile, and Colombia site networks — plus ex-US data bridges to FDA.
April 5, 2026
12
min read
By
BioAccess Editorial Team
In short
bioaccess® as a Latin American CRO achieves sub-12-month first-in-human dosing through parallelized execution across LatAm sites, with 60% faster recruitment than the US via KOL referral networks. Ex-US data bridges directly to FDA submissions under 21 CFR 812.28 — no bridging studies required.
**Key Takeaways**
- • Sub-12-month FIH dosing with parallelized CRO execution across LatAm sites
- • 60% faster recruitment than US through KOL referral networks and lower patient competition
- • MSA + work order blueprint for startups ensures budget predictability and milestone alignment
- • Ex-US data bridges to FDA without bridging studies — under 21 CFR 812.28 (see our FDA acceptance guide for Latin American clinical data)
- • Argentina and Chile offer unique site selection advantages for different device categories
**Who Is This For?**
This guide is for MedTech startup founders, VP Clinical Operations, and investors evaluating Latin American CRO partnerships for first-in-human medical device trials — particularly those seeking the fastest, most cost-effective path to initial clinical data with FDA submission readiness.
Why Use a LatAm CRO for Medical Device FIH Trials?
The traditional path for MedTech startups — designing and executing a first-in-human trial entirely in the United States — is increasingly untenable. FDA IDE applications take 6-12 months, US site activation adds 3-6 months, and the total cost can consume a large share of a startup's available capital on a single study.
Latin American CROs like bioaccess® have emerged as the strategic alternative, offering a fundamentally different value proposition for early-stage device companies.
The LatAm CRO Competitive Advantage
| Factor | US CRO | LatAm CRO (bioaccess®) | Advantage |
|---|---|---|---|
| Time to first patient | 12-18 months | 4-6 months | 60-70% faster |
| Regulatory pathway | FDA IDE required | Ethics-driven pathway | Simpler, faster |
| Recruitment speed | Baseline | 60% faster | Lower competition |
| FDA data acceptance | Automatic (domestic) | Under 21 CFR 812.28 | Equivalent |
| Investigator quality | High | High (US/EU trained) | Comparable |
What Is the MSA and Work Order Blueprint for Startups?
A well-structured Master Service Agreement (MSA) and work order are critical for startup-CRO relationships. Unlike large pharma companies with in-house legal teams, startups need MSA frameworks that protect their interests while enabling fast execution:
- Milestone-based payments: Structure payments around deliverables (ethics approval, first patient, data lock) rather than time-based installments — this aligns CRO incentives with sponsor timelines
- IP protection clauses: Ensure the MSA explicitly assigns all clinical data and study-related IP to the sponsor, with CRO retaining no rights to study results or device information
- Change order process: Define a streamlined change order process for protocol amendments, budget adjustments, and scope changes — critical for iterative EFS/FIH studies where the device may evolve
- Termination provisions: Include clear termination clauses with defined data handover procedures, ensuring the sponsor retains all data and can continue the study with a different CRO if needed
- Regulatory submission support: Explicitly include FDA submission support (CSR preparation, data formatting) in the work order scope — not as a separate engagement
How Should You Select Sites in Argentina and Chile?
bioaccess® leverages distinct site network advantages in Argentina and Chile for different device categories:
Argentina (ANMAT):
- Strong cardiovascular and orthopedic surgical infrastructure in Buenos Aires (Hospital Italiano, Fundación Favaloro)
- ANMAT approval process well-established for medical device clinical trials
- Favorable exchange rate dynamics — USD-denominated contracts with peso-denominated site costs create natural cost advantages
- Active academic medical center research culture with investigators experienced in multicenter device studies
Chile (ISP):
- Political stability and strong regulatory reputation enhance FDA acceptance of Chilean clinical data
- Santiago's private hospital network (Clínica Las Condes, Clínica Alemana) offers US-standard facilities without public hospital tender complications
- ISP clinical trial oversight is well-regarded internationally, supporting data credibility for global regulatory submissions
- Growing MedTech innovation ecosystem with government incentives for clinical research participation
Payment and Subcontractor Network Strategies
Payment alignment is critical for startup-CRO relationships in LatAm:
- USD-denominated contracts: All bioaccess® contracts are denominated in USD, eliminating exchange rate risk for international sponsors
- Milestone payments reduce upfront capital requirements — typical structure: 30% at MSA, 20% at ethics approval, 30% at first patient, 20% at data lock
- Site payments managed locally: bioaccess® handles all local currency payments to sites, investigators, and subcontractors — sponsors make single USD payments to bioaccess®
- Subcontractor pre-qualification: bioaccess® maintains pre-qualified networks of labs, imaging centers, pharmacies, and insurance providers — reducing vendor setup time by 4-6 weeks
Why Is Recruitment 60% Faster in LatAm Than the US?
Patient recruitment is consistently identified as the #1 driver of clinical trial delays and cost overruns globally. LatAm CROs achieve dramatically faster recruitment for medical device FIH trials:
| Recruitment Factor | United States | Latin America (bioaccess®) |
|---|---|---|
| Competing trials per indication | High (saturated markets) | Low (emerging market) |
| Patient willingness | Moderate (trial fatigue) | High (access to innovation) |
| Physician referral networks | Fragmented | Concentrated, KOL-driven |
| Screen-to-enrollment ratio | 3:1 to 5:1 | 2:1 to 3:1 |
| Time to enrollment target (10 pts) | 4-8 months | 2-4 months |
How Do You Submit LatAm FIH Data to the FDA?
For the complete framework, read our FDA acceptance guide for Latin American first-in-human studies.
A common concern for sponsors is whether FDA will accept clinical data generated at Latin American sites. The answer is clearly yes — and bioaccess® has a proven track record of successful FDA submissions referencing LatAm clinical data.
Under 21 CFR 812.28, FDA accepts foreign clinical data when:
- The study was conducted under Good Clinical Practice (ISO 14155 for devices)
- The clinical data is scientifically valid and relevant to the US target population
- Subject rights and safety were adequately protected throughout the study
- FDA can validate the data through inspection if necessary
**No Bridging Studies Required**
Multiple bioaccess® clients have successfully referenced LatAm FIH and EFS data in FDA IDE applications, 510(k) submissions, and De Novo classifications without separate bridging studies. The key is structuring the original study to meet FDA's requirements from the outset — including FDA-aligned endpoints, 21 CFR Part 11-compliant data management, and ICH E3-format clinical study reports.
Frequently Asked Questions
BA
bioaccess® · A CRO purpose-built exclusively for first-in-human clinical trials across Latin America. 50 companies accelerated since 2010 across 10+ countries.
Ready to Partner With a Latin America Medical Device CRO?
bioaccess® is the First-in-Human CRO — built across the Americas, from Canada to Argentina, purpose-built exclusively for first-in-human and early feasibility medical device trials. With sub-12-month FIH timelines, 50-65% cost savings, and FDA-accepted clinical data, we help MedTech startups bridge the gap between prototype and proof-of-concept.
Related resources:
- First-in-Human CRO Services — /first-in-human-cro
- Early Feasibility Studies — /early-feasibility-studies
- EFS CRO Latin America — /blog/early-feasibility-study-cro-latin-america
- FIH Medical Device Trial Chile — /blog/first-in-human-medical-device-trial-chile
- INVIMA Approval Colombia — /blog/invima-clinical-trial-approval-process-colombia