Parexel is one of the world's larger full-service global CROs, running Phase I–IV programs across the U.S., EU, and beyond. It's a strong choice for mid-to-large sponsors running pivotal, registration, or post-market programs at scale. 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® | Parexel |
|---|---|---|
| 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 Parexel and published US/EU benchmark ranges — not Parexel-specific figures. bioaccess® figures reflect our FIH FastTrack operating model.
Parexel's advantage is scale — deep therapeutic-area coverage, industrial-strength systems, and a global footprint tuned for pivotal and post-market programs. For an early-stage startup running its first FIH study, that scale is often more surface area than the job requires: a $350K study sits inside a very large 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 continue at our cost if agreed 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 — 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 CRO — including Parexel — for a pivotal or registration program.
Only in a narrow slice. Parexel 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, Parexel 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 Parexel (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 full-service global CRO like Parexel 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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