PPD, part of Thermo Fisher Scientific, is a global full-service CRO with broad therapeutic-area coverage across Phase I–IV programs. It's a strong choice for mid-to-large sponsors that need scale and integrated lab, bioanalytical, and late-phase services. bioaccess® is the First-in-Human CRO — built for the U.S. and Latin America — and only runs FIH studies for startups. If the next milestone is a clean, FDA-bridgeable first-in-human dataset on a startup timeline and budget, bioaccess® is purpose-built for it.
| Metric | bioaccess® | PPD (Thermo Fisher Scientific) |
|---|---|---|
| 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 PPD (Thermo Fisher Scientific) and published US/EU benchmark ranges — not PPD (Thermo Fisher Scientific)-specific figures. bioaccess® figures reflect our FIH FastTrack operating model.
PPD, backed by Thermo Fisher Scientific, is exactly what mid-to-large sponsors need for large, multi-region, multi-service programs: bioanalytical labs, central labs, biostatistics, real-world evidence, pharmacovigilance and commercialization at scale. That scope is broader than a startup running its first-in-human study typically needs — and cost structures reflect it.
bioaccess® is the opposite trade-off: FIH-only, startup-only, focused on U.S. regulatory anchoring plus Latin American execution. That single-focus operating model is what makes a 6–8 week study start, 4–8 week ethics approval, $15K–$35K per patient, and a 12-month protocol-to-LPLV written guarantee possible.
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 two models often work in sequence: run FIH with bioaccess®, then transfer to a PPD-class CRO for the pivotal.
Only in a narrow slice. PPD 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, PPD 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 PPD (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.
No — that's outside our scope. bioaccess® is focused on first-in-human clinical execution across the U.S. and Latin America, plus Latin American market access and device registration. For integrated bioanalytical, central lab, and large-scale late-phase services, a Thermo Fisher/PPD-class partner is a better fit. The two are frequently combined: FIH with bioaccess® to generate clean, regulator-ready data fast, then PPD for downstream services at scale.
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