Veranex is a MedTech-focused product-development and CRO group offering an end-to-end path from concept through design, engineering, preclinical and clinical, primarily inside US/EU networks. It's a strong choice for sponsors who need help earlier in the development lifecycle. bioaccess® is the First-in-Human CRO — built for the U.S. and Latin America — for sponsors whose next milestone is specifically a clean, FDA-bridgeable FIH dataset on a fundable timeline.
| Metric | bioaccess® | Veranex |
|---|---|---|
| Focus | FIH-only clinical execution for MedTech, Biopharma & Radiopharma startups | MedTech-focused product-development group — design, engineering, regulatory, preclinical and clinical services under one roof |
| Where they're strong | Latin American FIH execution: sites, ethics, import/export, monitoring, data — all in-house | End-to-end MedTech productization — from concept and human factors through preclinical to clinical, primarily US/EU |
| Clinical footprint | U.S. + 10 Latin American countries, 50+ pre-qualified sites | Primarily US/EU clinical networks; Latin American execution is not the category default |
| 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 |
| Pricing model | Fixed-price with 12-month risk-sharing guarantee — we work at our cost if we miss agreed milestones | Typically time-and-materials on a services basis |
| Regulatory standard for devices | ISO 14155 + Declaration of Helsinki; data eligible for FDA submission/review under 21 CFR 812.28 | ISO 14155-aligned; strong US FDA experience |
| Best-fit sponsor profile | Startups that already have a buildable device and need a fast, clean, FDA-bridgeable FIH dataset | Sponsors who need help earlier — design, human factors, verification & validation before clinical |
Comparison uses widely-known category facts about Veranex and published US/EU benchmark ranges — not Veranex-specific figures. bioaccess® figures reflect our FIH FastTrack operating model.
Veranex and bioaccess® aren't really the same category. Veranex is a MedTech product-development group offering the earlier parts of the lifecycle — concept, engineering, human factors, verification and validation, preclinical — plus clinical services, primarily in US/EU networks. bioaccess® is a clinical-execution CRO focused only on the first-in-human study, executed across the U.S. and Latin America.
If a sponsor still needs help getting to a buildable, testable device, Veranex is often the right partner. If the device is buildable and the protocol is locked, and the next milestone is FIH data on a startup budget and timeline, bioaccess® is purpose-built for that job — 6–8 week study start, 4–8 week ethics approval, $15K–$35K per patient, and a 12-month protocol-to-LPLV written guarantee.
Data is generated under ISO 14155 and the Declaration of Helsinki and is eligible for FDA submission and review under 21 CFR 812.28 — a case-by-case regulatory determination, not a guarantee of clearance or approval. The two models frequently work together in sequence: engineer with a product-development partner, then run FIH with bioaccess®.
Only in a narrow slice. Veranex 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, Veranex 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 Veranex (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.
No — that's outside our scope. bioaccess® is a clinical-execution CRO focused on first-in-human trials across the U.S. and Latin America, plus Latin American market access. For device design, human factors, verification & validation, or preclinical bench and animal work, a MedTech product-development group like Veranex is a better fit. Many sponsors pair the two: complete the productization work first, then run FIH with bioaccess®.
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