NAMSA is a large, globally-recognized medical-device CRO/MRO offering the full product lifecycle — regulatory consulting, testing and lab services, preclinical, clinical, and reimbursement — primarily anchored in the U.S. It's a strong choice for sponsors who want a single global vendor across the entire device lifecycle. bioaccess® is the First-in-Human CRO — built for the Americas — and only runs FIH studies for MedTech and Biopharma startups, and supports radiopharmaceutical and theranostics first-in-human and early feasibility trials. If your next milestone is a clean, FDA-bridgeable first-in-human dataset on a fundable timeline, bioaccess® is purpose-built for it.
| Metric | bioaccess® | NAMSA |
|---|---|---|
| Focus | FIH-only for MedTech and Biopharma startups, with radiopharma trial support | Full-service global CRO — all phases (I–IV), all therapeutic areas, all sizes; FIH is a small slice of the portfolio |
| Footprint | U.S. + 19 Latin American countries, 100+ sites | Global (50+ countries) — strong in U.S., EU, and APAC |
| Typical ethics / IRB timeline | Varies by study; we confirm per protocol (Latin American ethics committees) | 6–12 months typical in US jurisdictions |
| Typical per-patient cost | See sample budget | No published US comparison |
| FIH start (protocol → first patient) | Varies by study via FIH-12™; we confirm per protocol | Category benchmark: 6–12 months for large global CROs running FIH inside US networks |
| Pricing model | Fixed-price with 12-month risk-sharing guarantee — if we miss the protocol-to-LPLV timeline for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV | Typically time-and-materials or milestone-based; category norm includes change orders |
| Regulatory standard for devices | ISO 14155 + Declaration of Helsinki; data eligible for FDA submission/review under 21 CFR 812.28 | ISO 14155 and ICH E6 GCP; broad regulatory coverage worldwide |
| Best-fit sponsor profile | Seed-to-Series-B MedTech, Biopharma & Radiopharma startups running their first FIH study | Mid-to-large pharma/medtech running pivotal, registration, or post-market programs across regions |
| Post-trial support | Latin American market access, device registration in 19 countries, HTA & payer engagement | Extensive commercialization, real-world evidence and pharmacovigilance services worldwide |
Comparison uses widely-known category facts about NAMSA and published US benchmark ranges — not NAMSA-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
NAMSA is a category leader for exactly the sponsors it was built for: device sponsors that want a single global vendor across the full product lifecycle — regulatory strategy, testing and lab services, preclinical, clinical, and reimbursement — primarily inside US networks. Inside that scope, first-in-human execution in Latin America is one slice of a much larger portfolio.
bioaccess® makes that FIH-in-LATAM slice the entire business. FIH-only. Startup-only. U.S. regulatory anchoring plus execution anywhere from Canada down to Argentina. That single-focus operating model is what supports a timeline that varies by study (we confirm it per protocol) from protocol to first patient, study-specific ethics approval, a study-specific budget quote, and a 12-month protocol-to-LPLV written guarantee — with a risk-sharing clause: if we miss that timeline for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV.
Data is generated under ISO 14155 and the Declaration of Helsinki and is eligible for FDA submission and review under 21 CFR 812.28 (for devices) or ICH E6 for drugs and biologics — a case-by-case regulatory determination, not a guarantee of clearance or approval. The FIH package is designed to hand off cleanly to any downstream partner — including a full-lifecycle device CRO/MRO like NAMSA — for testing, reimbursement, or post-market work.
Only in a narrow slice. NAMSA is a large, reputable organization serving a broad customer base across many programs. bioaccess® is purpose-built for a single job: first-in-human clinical trials for MedTech and Biopharma startups, with support for radiopharmaceutical and theranostics trials, executed across the Americas. If your program is a global pivotal or a post-market study, NAMSA is often a better fit. If your program is your first-in-human trial and you need clean, FDA-bridgeable data on a startup budget and timeline, bioaccess® is purpose-built for it.
Clinical data from studies conducted outside the U.S. under ISO 14155 and the Declaration of Helsinki is eligible for FDA submission and review under 21 CFR 812.28 (for devices) and comparable ICH E6 pathways for drugs and biologics. Acceptance is a case-by-case regulatory determination, not a guarantee of clearance or approval — our regulatory team designs the study with the target FDA submission (IDE, 510(k), De Novo, PMA, HDE, IND) as the anchor.
FIH-12™ comes with a 12-month protocol-to-LPLV written guarantee and first-patient timing varies by study (we confirm it per protocol). Budget depends on study design; we provide a study-specific quote. Ethics committee review timelines in Latin American jurisdictions depend on each committee's meeting schedule.
Yes — sponsors regularly do. A common pattern is to run FIH with bioaccess® in Latin America to generate clean, regulator-ready data fast, then hand off to NAMSA (or a similar global CRO) for a multi-region pivotal, registration, or post-market program. Our regulatory strategy is designed to be portable so that data and documentation transfer cleanly to any downstream CRO.
You want a single global vendor for the entire medical-device lifecycle — bench and biocompatibility testing through preclinical, clinical, and post-market — rather than a focused first-in-human-in-Latin-America partner. In that case, a full-lifecycle device CRO/MRO like NAMSA is a natural fit. bioaccess® is the better fit when the specific next milestone is a clean, FDA-bridgeable first-in-human dataset on a startup budget and timeline.
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