ACTIVA CRO is a Latin American regional CRO with a multi-country footprint, working across medical devices and pharma. It's a reputable choice for sponsors that want regional Latin American coverage across trial phases and therapeutic areas. bioaccess® is the First-in-Human CRO — built for the U.S. and Latin America — and only runs FIH studies for MedTech, Biopharma and Radiopharma startups, with U.S. regulatory anchoring, a 12-month protocol-to-LPLV written guarantee, and a documented track record of 3 Fortune 500 acquisitions of client companies.
| Metric | bioaccess® | ACTIVA CRO |
|---|---|---|
| Focus | FIH-only for MedTech, Biopharma & Radiopharma startups — the entire business | Category-level: full-service or FIH-adjacent CRO; first-in-human is one line of business among others |
| Country footprint | U.S. + 10 Latin American countries, 50+ pre-qualified sites | Category-level: narrower geographic optionality (single country or a shorter LATAM list) |
| U.S. regulatory anchoring | In-house U.S. regulatory strategy: FDA Pre-Sub / Q-Sub, IDE, 510(k), De Novo, PMA, HDE, IND — designed as the anchor for LATAM execution | Category-level: varies by shop; U.S. FDA strategy is not always the anchoring lens |
| Timeline commitment | 12-month protocol-to-LPLV written guarantee — we work at our cost if we miss agreed milestones | Category-level: written milestone guarantees are uncommon in the CRO market |
| FIH start (protocol → first patient) | 6–8 weeks via FIH FastTrack | Category-level: varies; not typically compressed to a 6–8 week start |
| Typical per-patient cost | $15K–$35K | $40K–$75K in US/EU benchmark ranges; LATAM shops typically fall between the two |
| Track record on FIH exits | 3 Fortune 500 acquisitions of bioaccess® clients (Mitralign → Edwards; ClarVista → Alcon; ForSight VISION5 → Allergan/AbbVie) | Category-level: acquisition track records vary; this specific FIH-to-Fortune-500 pattern is bioaccess®'s. |
| Team credentials | ACRP-certified project managers and monitors; founded 2010 by two interventional cardiologists (one Harvard-trained) | Category-level: reputable teams; specific credential mix varies |
| Regulatory standard for devices | ISO 14155 + Declaration of Helsinki; data eligible for FDA submission/review under 21 CFR 812.28 | ISO 14155-aligned; category-standard for medical-device trials |
| Post-trial support | Latin American market access, device registration in 10 countries, HTA & payer engagement | Category-level: post-trial support scope varies by shop |
Comparison uses widely-known category facts about ACTIVA CRO and published US/EU benchmark ranges — not ACTIVA CRO-specific figures. bioaccess® figures reflect our FIH FastTrack operating model.
ACTIVA CRO and bioaccess® both operate inside Latin America, but with different scopes. ACTIVA CRO is a regional full-service CRO working across devices and pharma and across trial phases — a capable choice if the goal is broad regional Latin American coverage under one vendor. bioaccess® is exclusively first-in-human for MedTech, Biopharma and Radiopharma startups, with U.S. regulatory anchoring as the design lens.
That FIH-only exclusivity is what supports the 12-month protocol-to-LPLV written guarantee, the 6–8 week study start, and the 4–8 week ethics approval. It's also what supports the specific pattern of 3 Fortune 500 acquisitions of client companies (Mitralign → Edwards Lifesciences; ClarVista Medical → Alcon; ForSight VISION5 → Allergan/AbbVie) — an FIH-to-strategic-exit track record.
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. If your program is broader than FIH, a regional CRO like ACTIVA is a capable choice; if FIH is the job, bioaccess® is purpose-built for it.
Only in a narrow slice. ACTIVA CRO 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, ACTIVA CRO 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 ACTIVA CRO (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.
You need a regional Latin American partner across the full trial lifecycle — Phase I–IV, devices and pharma — under one vendor, or your program is a later-phase pharma study or post-market registry rather than a first-in-human trial. In that case, a full-service LATAM regional CRO like ACTIVA CRO is a natural fit. bioaccess® is the better fit when the specific next milestone is a clean, FDA-bridgeable first-in-human dataset on a startup budget and timeline.
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