First In Humans is a Panama-focused medical-device first-in-human CRO offering end-to-end trial facilitation in Panama with CNBI-accredited IRBs. It's a solid choice if Panama is the answer for your specific program. bioaccess® is a multi-country FIH platform: Panama is one of 10 Latin American markets we operate in, alongside U.S. regulatory anchoring, 50+ pre-qualified sites, a 12-month protocol-to-LPLV written guarantee, and a track record of 3 Fortune 500 acquisitions of client companies.
| Metric | bioaccess® | First In Humans |
|---|---|---|
| Focus | FIH-only for MedTech, Biopharma & Radiopharma startups — the entire business | Category-level: full-service or FIH-adjacent CRO; first-in-human is one line of business among others |
| Country footprint | U.S. + 10 Latin American countries, 50+ pre-qualified sites | Category-level: narrower geographic optionality (single country or a shorter LATAM list) |
| U.S. regulatory anchoring | In-house U.S. regulatory strategy: FDA Pre-Sub / Q-Sub, IDE, 510(k), De Novo, PMA, HDE, IND — designed as the anchor for LATAM execution | Category-level: varies by shop; U.S. FDA strategy is not always the anchoring lens |
| Timeline commitment | 12-month protocol-to-LPLV written guarantee — we work at our cost if we miss agreed milestones | Category-level: written milestone guarantees are uncommon in the CRO market |
| FIH start (protocol → first patient) | 6–8 weeks via FIH FastTrack | Category-level: varies; not typically compressed to a 6–8 week start |
| Typical per-patient cost | $15K–$35K | $40K–$75K in US/EU benchmark ranges; LATAM shops typically fall between the two |
| Track record on FIH exits | 3 Fortune 500 acquisitions of bioaccess® clients (Mitralign → Edwards; ClarVista → Alcon; ForSight VISION5 → Allergan/AbbVie) | Category-level: acquisition track records vary; this specific FIH-to-Fortune-500 pattern is bioaccess®'s. |
| Team credentials | ACRP-certified project managers and monitors; founded 2010 by two interventional cardiologists (one Harvard-trained) | Category-level: reputable teams; specific credential mix varies |
| Regulatory standard for devices | ISO 14155 + Declaration of Helsinki; data eligible for FDA submission/review under 21 CFR 812.28 | ISO 14155-aligned; category-standard for medical-device trials |
| Post-trial support | Latin American market access, device registration in 10 countries, HTA & payer engagement | Category-level: post-trial support scope varies by shop |
Comparison uses widely-known category facts about First In Humans and published US/EU benchmark ranges — not First In Humans-specific figures. bioaccess® figures reflect our FIH FastTrack operating model.
First In Humans is a category example of the single-country specialist — a solid choice when Panama is clearly the right jurisdiction for your device and program. bioaccess® is the category example of a multi-country FIH platform: Panama is one of 10 Latin American markets we operate in, chosen against your target FDA submission and the specific patient population you need to reach.
The multi-country model is what lets us de-risk site selection, backstop enrollment across jurisdictions, and back the whole thing with a 12-month protocol-to-LPLV written guarantee — with a risk-sharing clause that keeps us working at our cost if agreed milestones slip. It's also what supports the specific pattern of 3 Fortune 500 acquisitions of client companies.
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. If Panama is unambiguously the answer, a Panama specialist is a natural fit; if country choice is part of the strategy, bioaccess® gives you the optionality.
Only in a narrow slice. First In Humans is a capable, reputable CRO. bioaccess® is purpose-built for a single job: first-in-human clinical trials for MedTech, Biopharma and Radiopharma startups, executed across the U.S. and Latin America. If your program is a global pivotal or a post-market study, First In Humans 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.
A standard 10-patient, single-site FIH study through FIH FastTrack runs roughly $350K all-in, with a 12-month protocol-to-LPLV written guarantee and a 6–8 week study start. Per-patient cost is $15K–$35K vs. $40K–$75K in US/EU benchmark ranges. Ethics approval is 4–8 weeks in Latin American jurisdictions vs. 6–12 months in the US/EU.
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 First In Humans (or another CRO suited to that later-phase work) 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.
It depends on how settled the country choice is. If Panama is clearly the right jurisdiction for your device, patient population, and FDA plan, a Panama specialist like First In Humans is a natural fit. If the country choice is part of the strategy — including Panama, but also Colombia, Chile, Brazil, Argentina, Mexico, and other Latin American markets — bioaccess® gives you a documented 10-country platform with 50+ pre-qualified sites and U.S. regulatory anchoring.
Panama is unambiguously the answer and you want a specialist focused on that single jurisdiction. In that case, a Panama-focused CRO with CNBI-accredited IRB experience is a natural fit. bioaccess® is the better fit when you want country optionality across Latin America plus U.S. regulatory anchoring under one FIH-only partner.
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