Last checked October 1, 2026. General information, not legal or regulatory advice. bioaccess® is not affiliated with Altasciences. Names belong to their owners and are used here only to identify their offer. Every statement about Altasciences 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.
Altasciences is an early-phase drug/biopharma CRO with 25+ years of experience serving pharma, biotech, and generics companies across the US and Canada. Its lane is the early drug path: preclinical safety testing (GLP and non-GLP), Phase I clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management. If your next milestone is a US/Canada Phase I drug program, that is a strong fit. 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, backed by a 12-month protocol-to-LPLV written guarantee.
| Metric | bioaccess® | Altasciences |
|---|---|---|
| Focus | FIH-only for MedTech, Biopharma & Radiopharma startups | Early-phase CRO — preclinical safety testing plus Phase I clinical pharmacology, across the US and Canada |
| Program scope | One job: the first-in-human study, run end-to-end (regulatory, sites, ethics, import, conduct, dataset) | Full early drug-development stack: preclinical safety, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management |
| Footprint | Americas — from Canada to Argentina; 19 Latin American and Caribbean countries, 50+ pre-qualified sites | US and Canada facilities — North-America-bound early-phase network |
| Device vs drug fit | MedTech devices (ISO 14155) plus Biopharma and Radiopharma FIH — FDA-bridgeable data under 21 CFR 812.28 / ICH E6 | Drug/biopharma and generics focus — preclinical GLP/non-GLP safety testing and Phase I clinical pharmacology for pharma/biotech sponsors |
| Typical ethics / IRB timeline | 4–8 weeks (Latin American ethics committees) | Program- and jurisdiction-dependent — Altasciences publishes no startup FIH timeline commitments |
| Pricing model | Transparent per-patient and milestone pricing; $15K–$35K per patient typical | No public pricing; scoped per program |
Comparison uses widely-known category facts about Altasciences and published US/EU benchmark ranges — not Altasciences-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
Altasciences and bioaccess® answer different first questions. Altasciences asks: how do we move a drug or biologic through the early development path — preclinical safety, first-in-human pharmacology, bioanalysis, and the program management that keeps an early drug program on rails? With 25+ years serving pharma, biotech, and generics across the US and Canada, that machinery is the product.
bioaccess® asks a narrower question: where and how does this startup's first-in-human study happen — and how does its dataset survive FDA review? 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. Where the geography decision matters, bioaccess® brings a comparison the North-America-bound CROs do not: US vs Canada vs LATAM vs Australia, with LATAM execution where speed and per-patient economics win.
Only in a narrow slice. Altasciences 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 Americas. If your program is a global pivotal or a post-market study, Altasciences 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 Altasciences (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.
Your program is a US/Canada Phase I drug or biologic program that needs preclinical safety testing, clinical pharmacology, bioanalysis, and the full early-development support stack under one roof. In that case, an early-phase drug CRO like Altasciences is a natural fit. bioaccess® is the better fit when the specific next milestone is a clean, FDA-bridgeable first-in-human dataset — for a MedTech device, a biopharma candidate, or a radiopharma tracer — executed end-to-end on a startup budget and timeline.
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