Clinical Trial Services — U.S. & Latin America — bioaccess®

bioaccess® offers a full suite of clinical trial services for MedTech, Biopharma, and Radiopharma companies. We anchor on U.S. regulatory strategy (FDA Pre-Sub, IND/IDE) and execute across Latin America.

Service Offerings

• First-in-Human (FIH) Clinical Trials — end-to-end FIH trial management with 12-month timeline guarantee
• Early Feasibility Studies (EFS) — FDA IDE-ready early feasibility device studies
• Radiopharmaceutical Trials — Lu-177, Ac-225, Ga-68 clinical studies with nuclear medicine infrastructure
• Medical Device Registration — ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID pathways
• Market Access Strategy — Latin American market entry for FDA/CE-cleared devices
• Clinical Trial Site Search & Selection — 50+ pre-qualified sites in 10 countries
• Regulatory Strategy — FDA bridge data, ICH-GCP compliance, 21 CFR 812.28
• FIH FastTrack Program — accelerated FIH pathway with guaranteed timelines

Request a Proposal