Last checked October 1, 2026. General information, not legal or regulatory advice. bioaccess® is not affiliated with CogenTech, Cogent Technologies Corp., Zelery-Med Corporation, or LearUp Systems. Names belong to their owners and are used here only to identify their offer. Every statement about CogenTech is taken from its public website as listed on October 1, 2026 (sources under the comparison table). Offers change, so confirm current terms with each provider.
CogenTech is a tech-enabled MedTech program management organization (PMO) — program leadership, regulatory and quality consulting, clinical operations coordination, and its proprietary LearUp platform — operating on a shared-risk model from first-in-human through pivotal. It has real device-trial proof, including program support behind Reflow Medical's DEEPER REVEAL pivotal trial that led to FDA De Novo clearance. bioaccess® is the First-in-Human CRO — an Americas company operating from Canada to Argentina — and only runs FIH studies for MedTech, Biopharma and Radiopharma startups, with U.S. FDA strategy anchored in Miami and execution across 19 Latin American and Caribbean countries. If your next milestone is a clean, FDA-bridgeable first-in-human dataset on a startup timeline, bioaccess® is purpose-built for it; if you want a PMO layer coordinating a multi-year, multi-phase device program, CogenTech is built for that.
| Metric | bioaccess® | CogenTech |
|---|---|---|
| Focus | FIH-only for MedTech, Biopharma & Radiopharma startups | Tech-enabled PMO — program leadership across the device lifecycle, first-in-human to pivotal |
| Operating model | Execution CRO — runs the FIH trial end-to-end under one roof | Program management organization — coordinates sponsors, sites, and vendors on the LearUp platform; shared-risk model |
| Footprint | Americas — from Canada to Argentina; 19 Latin American and Caribbean countries, 50+ pre-qualified sites | US HQ (Mahwah, NJ) plus Australia office; team spans the US, Canada, Australia, EU and Latin America; 500+ site network |
| FIH proof | FIH-only practice; 12-month protocol-to-LPLV written guarantee | FIH experience via program leadership (e.g., EU-MDR first-in-human case study); named De Novo win supporting Reflow Medical's DEEPER REVEAL pivotal trial |
| Typical ethics / IRB timeline | 4–8 weeks (Latin American ethics committees) | Program- and jurisdiction-dependent — CogenTech publishes no FIH timeline commitments |
| Pricing model | Transparent per-patient and milestone pricing; $15K–$35K per patient typical | No public pricing; shared-risk program engagement, scoped per program |
CogenTech facts above are taken from its public website as listed under the comparison table (October 1, 2026) — category-level descriptions, not CogenTech-internal figures. bioaccess® figures reflect our FIH-12™ operating model and are independently verifiable in our case studies.
CogenTech's own positioning is the tell: 'beyond a CRO' — a Project Management Organization that brings visibility, control, and shared accountability to complex clinical development programs. Its value is program leadership and governance: QMS build-out, regulatory strategy, country submissions, TMF audits, site coordination, and the LearUp platform tying stakeholders together. For a multi-year device program spanning FIH through pivotal, that coordination layer is the product.
bioaccess® is the opposite structural bet: not the coordination layer, the execution engine — and only for first-in-human. FIH-only. Startup-only. U.S. FDA strategy anchored in Miami plus execution across the Americas, from Canada to Argentina. That focus is what supports a typical 4–8 months from protocol to first patient, 4–8 week ethics approval, $15K–$35K per patient, and a 12-month protocol-to-LPLV written guarantee — with a risk-sharing clause: if we miss that timeline for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV.
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 can even sequence: run the FIH with bioaccess®, then hand the dataset to a PMO-led program for pivotal — including CogenTech.
Only in a narrow slice. CogenTech 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 Americas. If your program is a global pivotal or a post-market study, CogenTech 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 CogenTech (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.
You want a program-management layer — governance, QMS, regulatory submissions, TMF readiness, and platform tooling — coordinating a multi-year MedTech program from first-in-human through pivotal under a shared-risk model. In that case, a tech-enabled PMO like CogenTech is a natural fit. bioaccess® is the better fit when the specific next milestone is a clean, FDA-bridgeable first-in-human dataset executed end-to-end on a startup budget and timeline.
All CRO comparisons · First-in-Human CRO · Clinical Trials in Panama · Book a free 30-min strategy call