Last checked 1 October 2026. General information, not legal or regulatory advice. bioaccess® is not affiliated with, endorsed by, or sponsored by Veranex. Public facts change; verify current terms with qualified advisers.
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 — and it has made early feasibility a strategic focus, appointing ex-FDA EFS-pathway lead Jose Pablo Morales, M.D. as Chief Medical Officer (November 2025) and launching EFS Explorer for EFS site selection with MDIC (September 2026). bioaccess® is the First-in-Human CRO — built for the Americas — 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 and Biopharma startups, with radiopharma trial support | 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. + 19 Latin American countries, 100+ 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 — 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 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 |
| Early feasibility (EFS) positioning | FIH-12™ — FDA strategy and EFS-IDE planning from Miami, execution across 19 Latin American and Caribbean countries, and an honest geography assessment of where each study belongs | Veranex has made EFS a strategic focus: ex-FDA EFS-pathway lead Jose Pablo Morales, M.D. as CMO (Nov 2025) and EFS Explorer for EFS site selection with MDIC (Sep 2026) |
| 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-12™ 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 Americas.
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 — first patient typically 4–8 months after protocol, 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®.
On early feasibility specifically, Veranex's move is credible and worth taking seriously: Dr. Jose Pablo Morales led the implementation and adoption of the FDA's Early Feasibility Studies pathway from inside the agency, and EFS Explorer (built with MDIC) is aimed at the US site-selection bottleneck that MDIC's own survey data documents — most EFS still run outside the US. Where bioaccess® differs is in the operating model and the geography decision. We are FIH-only and startup-exclusive, and we do not assume every study belongs in Latin America: our FDA strategy team in Miami plans the EFS-IDE path, then we give sponsors an honest assessment of where their study belongs — a US EFS where the case fits, Latin America where speed and per-patient economics win — with the dataset built to survive FDA review under 21 CFR 812.28 either way.
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 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, 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 ~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 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.
Veranex has made early feasibility a strategic focus. In November 2025 it appointed Jose Pablo Morales, M.D. — who, per the announcement, led the implementation and adoption of the FDA's Early Feasibility Studies pathway as a Senior Medical Advisor in the FDA's Office of Clinical Policy — as Chief Medical Officer. In September 2026 it launched EFS Explorer with the Medical Device Innovation Consortium (MDIC) to streamline EFS site selection. Both are credible EFS moves; the comparison above covers where the two companies' operating models differ.
No — that's outside our scope. bioaccess® is a clinical-execution CRO focused on first-in-human trials across the Americas, 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®.
All CRO comparisons · First-in-Human CRO · Clinical Trials in Panama · Book a free 30-min strategy call