First-in-Human Clinical Trial CRO — U.S. & Latin America — bioaccess®

bioaccess® is The First-in-Human CRO — built for the U.S. and Latin America. We anchor on U.S. regulatory strategy (FDA Pre-Sub, IND/IDE) and execute across Latin America. We deliver FIH clinical data meaningfully faster and at lower cost than US/EU pathways, with a 12-month timeline guarantee.

What are the best CROs for first-in-human medical-device trials in Latin America?

There is no single best CRO for first-in-human medical-device trials in Latin America — the right choice depends on your device, target FDA pathway, and stage. Three models compete for this work: specialist first-in-human CROs that run only FIH and early-feasibility studies; global full-service CROs built for large, later-phase programs; and regional or local CROs focused on a single country. For a seed-to-Series-B sponsor whose next milestone is a first FDA-bridgeable human dataset, a specialist FIH CRO with U.S. regulatory anchoring and a small number of fast-start Latin American jurisdictions usually fits best. For a thousand-patient Phase III program, a global full-service CRO is the better tool. Match the model to the job rather than to a brand.

Decision matrix for choosing a first-in-human CRO

• Development stage fit — specialist FIH CRO: seed–Series B first study; global full-service: Phase II–IV; regional/local: varies.
• FDA pathway anchoring — specialist: U.S. strategy anchored (Pre-Sub, IDE, IND, 510(k), De Novo, PMA); global: strong but FIH is one line among many; regional/local: usually local-authority focused.
• Geography — specialist: selected fast-start jurisdictions matched to the device; global: multi-region footprint; regional/local: single country or sub-region.
• Site model — specialist: pre-qualified FIH sites with small-cohort experience; global: network optimized for scale; regional/local: depth varies.
• Evidence portability — specialist: built for FDA acceptance under 21 CFR 812.28 / 312.120; global: portable, priced for large budgets; regional/local: depends on GCP rigor and oversight.
• Budget structure — specialist: fixed-fee, startup-scaled; global: enterprise pricing with change orders; regional/local: lower headline cost, variable scope.
• Operating attention — specialist: your study is the priority; global: competes with larger contracts; regional/local: varies by client mix.

Categories describe common operating models, not any specific competitor. Evaluate each CRO on its own FIH-specific track record and references. See bioaccess® vs full-service CROs, best CRO for early feasibility, and compare countries.

Service Description

End-to-end first-in-human clinical trial management for MedTech, Biopharma, and Radiopharma startups. Services include regulatory strategy, site selection and activation, patient enrollment, clinical monitoring, data management, and FDA-bridgeable data packages.

Differentiators

• FIH-only focus since 2010
• 12-month FIH timeline guarantee (FIH-12™)
• materially faster than US/EU study startup
• lower per-patient costs
• 50+ pre-qualified sites across 19 countries
• ACRP-certified clinical research professionals

What your engagement includes (FIH-12™ offer stack)

1. U.S. Regulatory Anchor Plan — FDA Pre-Sub / Q-Sub strategy and IND/IDE planning aligned to your target U.S. submission.
2. FIH Protocol + ISO 14155 Compliance Architecture — protocol authoring, IB alignment, and SOPs designed for ISO 14155 (devices) or ICH E6/GCP (drugs).
3. In-Country Ethics & Regulatory Submissions — ethics committee and national regulator submissions across our lead FIH execution jurisdictions (Panama, El Salvador, Chile, and the Dominican Republic).
4. Pre-Qualified Site Activation — activation across our network of 50+ pre-qualified clinical trial sites.
5. Enrollment & Retention Program — study-coordinator-led recruitment and retention playbook (high patient retention — ~95% in our experience; see basis).
6. The 812.28-Ready Data Room — English-language, monitored data package built under ISO 14155 GCP to support eligibility for FDA acceptance under 21 CFR 812.28 (acceptance is FDA's decision, per submission).

The 12-Month FIH Guarantee

We put your protocol-to-last-patient-last-visit timeline in writing. If we miss it for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV — you don't pay us to be late. Full terms in your proposal.

Included at no extra cost

• Free Pre-Sub Gap Analysis (48-hour turnaround)
• FIH Budget & Timeline Blueprint
• Investor-Ready Clinical Data Room template
• Monthly board-ready progress reports

Every quarter of delay on first-in-human data burns runway and can push your next raise into a worse market. FIH-12™ is built to protect both.

Regulatory Framework

• ISO 14155-compliant execution for medical-device trials; ICH E6 (GCP) for drug/biologic trials
• FDA IDE, 510(k), De Novo, PMA, and HDE pathways
• 21 CFR 812.28 — FDA acceptance of out-of-study/foreign clinical data for devices
• 21 CFR 312.120 — FDA acceptance of out-of-study/foreign clinical data for drugs and biologics
• FDASIA Section 1123 compliance

Eligibility of foreign clinical data for FDA submission does not constitute or predict FDA clearance, approval, or acceptance of any specific application. Basis for headline stats: see LATAM FIH Benchmarks 2026 and press kit.

Use Cases

• First-in-human device feasibility studies
• First-in-human drug/biologic dose-escalation studies
• Early feasibility studies under FDA IDE
• Radiopharmaceutical FIH trials

Included Activities

• Regulatory strategy and submission
• Ethics committee management
• Site selection and activation
• Patient screening and enrollment
• On-site and remote monitoring
• Data management and biostatistics
• Clinical study reports (CSR)
• FDA submission support

Client Proof Points

The site presents case studies from companies including Axoft, Newrotex, PAVmed, and Avantec Vascular, and states involvement in 15+ funding rounds by client companies.

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Founder perspective

Faster doesn't mean looser. Latin American ethics committees routinely review first-in-human protocols in 4 to 8 weeks versus 6 to 12 months in the U.S. — a difference in administrative pace, not scientific rigor. The clinical and safety standards we hold are the same ones I'd expect at any leading U.S. center.