How long does a first-in-human trial take?

With bioaccess®, first-in-human trials in Latin America reach first patient on a timeline that varies by study (we confirm it per protocol), and FIH-12™ puts the 12-month protocol-to-LPLV timeline in writing. Ethics/IRB approval lands in 4–8 weeks (versus 6–12 months in the US/EU). Enrollment for a 10–30 patient FIH cohort usually completes on a timeline that varies by study (we confirm it per protocol) at our pre-qualified sites.

How much does a first-in-human trial cost?

Total cost for a first-in-human (FIH) study depends on device complexity, indication, the number of sites and patients, follow-up length, imaging and core lab requirements, device import and logistics, and clinical trial insurance. See our sample budget page and the 2026 LATAM FIH Benchmarks report for illustrative cost bands.

What is the difference between a first-in-human trial and a Phase I trial?

For drugs, the terms are essentially synonymous — the first Phase I study is the first-in-human study. For medical devices, the FIH equivalent is called an Early Feasibility Study (EFS) under 21 CFR 812.28, not Phase I. bioaccess® runs both device EFS and drug FIH pathways.

Who runs first-in-human trials?

First-in-human trials are typically run by a specialist contract research organization (CRO) on behalf of the sponsor company (a MedTech, Biopharma, or Radiopharma startup). bioaccess® is a First-in-Human CRO — purpose-built exclusively for FIH studies, with U.S. regulatory anchoring and Latin American execution.

What documents do I need to start a first-in-human trial?

The core package includes: an investigator's brochure or device description, a clinical study protocol, ISO 10993 biocompatibility (for devices) or IND-enabling toxicology (for drugs), a risk analysis, informed consent forms, a monitoring plan, and a data management plan. bioaccess® prepares regulator-ready versions of all of these as part of the FIH-12™ engagement.

The complete guide to first-in-human trials

A first-in-human (FIH) trial is the first time an investigational device, drug, or biologic is tested in real people. It is small (10–30 patients), short (3–12 months), and decides whether your invention becomes credible to regulators, investors, and acquirers. bioaccess® runs FIH studies in Latin America with first-patient timing that varies by study (we confirm it per protocol), with budgets driven by device complexity, number of sites and patients, follow-up length, and imaging, with data generated under ISO 14155 / ICH-E6 controls intended to support an FDA IDE or IND submission.

First-in-human trials at a glance

Protocol to first patient: varies by study; we confirm per protocol
Ethics/IRB approval: varies by study; we confirm per protocol
Cost per patient: see the sample budget
FDA-bridgeable data: 21 CFR 812.28

What is a first-in-human (FIH) trial?

A first-in-human trial is the very first study in which a new medical device, drug, or biologic is tested in real people. For medical devices, the equivalent FDA pathway is an Early Feasibility Study under 21 CFR 812.28. FIH studies are small (typically 10–30 patients), short, and designed to generate the first clean safety and mechanism-of-action data an agency, investor, or acquirer will accept.

Where should I run my first-in-human trial?

The best FIH destinations balance regulator quality, site experience, cost, and speed. bioaccess® runs FIH studies with a network of 100+ sites across 19 Latin American & Caribbean countries — including Mexico (COFEPRIS), Argentina (ANMAT), Brazil (ANVISA), Panama, Chile, and the Dominican Republic. All data is generated under ICH-GCP / ISO 14155 controls intended to support an FDA IDE or IND submission.

Will the FDA accept first-in-human data generated in Latin America?

Yes. Under 21 CFR 812.28 (device) and FDASIA Section 1123 (drug), the FDA accepts foreign clinical data when the study is conducted under GCP-equivalent controls (ICH-E6, ISO 14155), the sites and investigators are qualified, and the data is monitored and reproducible. bioaccess® designs every FIH study to those standards from day one.

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