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.
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)
U.S. Regulatory Anchor Plan — FDA Pre-Sub / Q-Sub strategy and IND/IDE planning aligned to your target U.S. submission.
FIH Protocol + ISO 14155 Compliance Architecture — protocol authoring, IB alignment, and SOPs designed for ISO 14155 (devices) or ICH E6/GCP (drugs).
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).
Pre-Qualified Site Activation — activation across our network of 50+ pre-qualified clinical trial sites.
Enrollment & Retention Program — study-coordinator-led recruitment and retention playbook (high patient retention — ~95% in our experience; see basis).
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.
The site presents case studies from companies including Axoft, Newrotex, PAVmed, and Avantec Vascular, and states involvement in 15+ funding rounds by client companies.
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.