Medpace is a large, reputable full-service global CRO that runs Phase I–IV programs across the U.S., EU and beyond — it's a strong choice for mid-to-large sponsors running pivotal or registration studies. bioaccess® is the First-in-Human CRO built for the U.S. and Latin America and works only on FIH studies for MedTech, Biopharma and Radiopharma startups. 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® | Medpace |
|---|---|---|
| Focus | FIH-only for MedTech, Biopharma & Radiopharma startups | Full-service global CRO — all phases (I–IV), all therapeutic areas, all sizes; FIH is a small slice of the portfolio |
| Footprint | U.S. + 10 Latin American countries, 50+ pre-qualified 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) | 6–8 weeks via FIH FastTrack | 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 — we work at our cost if we miss agreed milestones | 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 10 countries, HTA & payer engagement | Extensive commercialization, real-world evidence and pharmacovigilance services worldwide |
Comparison uses widely-known category facts about Medpace and published US/EU benchmark ranges — not Medpace-specific figures. bioaccess® figures reflect our FIH FastTrack operating model.
The core contrast isn't quality — Medpace is a well-regarded global CRO. The contrast is fit-for-purpose. A large full-service CRO exists to serve mid-to-large sponsors running large, multi-phase, multi-region programs. Inside that portfolio, a $350K first-in-human study for a Series A startup is a small line item competing for attention with $50M pivotal programs.
bioaccess® makes first-in-human the entire business. That singular focus lets us compress an FIH study to a 6–8 week start in Latin America, deliver ethics approval in 4–8 weeks, hold per-patient cost to $15K–$35K, and back the whole thing with a 12-month protocol-to-LPLV written guarantee. If we miss an agreed milestone, we continue working at our own cost.
The data we generate is designed from day one to be eligible for FDA submission and review under 21 CFR 812.28 (for devices) or ICH E6 for drugs and biologics — with U.S. regulatory anchoring so the FIH study cleanly hands off to whichever CRO runs your downstream pivotal or registration program.
Only in a narrow slice. Medpace 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, Biopharma and Radiopharma startups, executed across the U.S. and Latin America. If your program is a global pivotal or a post-market study, Medpace 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 Medpace (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.
If your FIH is really an FIH-plus-pivotal program that must run across multiple US/EU countries under a single global CRO umbrella, a large full-service CRO like Medpace is often the better structural fit. bioaccess® is the better fit when the goal is a clean, fast, cost-controlled first-in-human dataset that unlocks the next milestone — funding, FDA submission, or acquisition — and can be handed off to a full-service CRO afterward.
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