ICON plc is one of the world's largest full-service CROs — strong across Phase I–IV, all therapeutic areas, and 50+ countries. It's a strong choice for mid-to-large sponsors running pivotal and post-market programs at scale. bioaccess® is the FIH-only CRO built for the Americas and only runs first-in-human trials for startups. If your next milestone is a clean, FDA-bridgeable first-in-human dataset on a startup budget and timeline, bioaccess® is purpose-built for it.
| Metric | bioaccess® | ICON plc |
|---|---|---|
| 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 | 4–8 weeks (Latin American ethics committees) | 6–12 months typical in US/EU jurisdictions |
| Typical per-patient cost | $15K–$35K | $40K–$75K in US/EU benchmark ranges |
| FIH start (protocol → first patient) | Typically 4–8 months via FIH-12™ | Category benchmark: 6–12 months for large global CROs running FIH inside US/EU 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 ICON plc and published US/EU benchmark ranges — not ICON plc-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
ICON's scale is its advantage — a global operating footprint, deep therapeutic-area coverage, and industrial-strength systems for pivotal and post-market programs. For an early-stage startup running its first FIH study, that scale is often overkill: the $300K–$500K study lives inside a $500M portfolio and rarely gets the operational attention it needs on a founder-critical timeline.
bioaccess® is structurally the opposite: FIH-only, startup-only, focused on U.S. regulatory anchoring plus Latin American execution. That focus is what lets us hold a 12-month protocol-to-LPLV written guarantee and hand back working capital instead of change orders when milestones slip.
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. Not a guarantee of clearance or approval — a case-by-case regulatory determination — but designed from day one to be portable to whichever CRO runs your downstream pivotal.
Only in a narrow slice. ICON plc 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, ICON plc 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 ~10-patient FIH study through FIH-12™ runs $300K–$500K, with a 12-month protocol-to-LPLV written guarantee and first patient typically 4–8 months after protocol. 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 ICON plc (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.
Per-patient cost with bioaccess® is $15K–$35K vs. $40K–$75K in US/EU benchmark ranges for a large global CRO running FIH inside its US/EU networks. A typical 10-patient FIH study through FIH-12™ is $300K–$500K. We publish these numbers because they are the outcome of a single-focus operating model — not a discount on the same cost structure.
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