First-in-Human Clinical Trial CRO — U.S. & Latin America — bioaccess®

bioaccess® is The First-in-Human CRO — built for the U.S. and Latin America. We anchor on U.S. regulatory strategy (FDA Pre-Sub, IND/IDE) and execute across Latin America. We deliver FIH clinical data 40% faster and 30% cheaper than US/EU pathways, with a 12-month timeline guarantee.

Service Description

End-to-end first-in-human clinical trial management for MedTech, Biopharma, and Radiopharma startups. Services include regulatory strategy, site selection and activation, patient enrollment, clinical monitoring, data management, and FDA-bridgeable data packages.

Differentiators

• FIH-only focus since 2010
• 12-month FIH timeline guarantee (FIH FastTrack)
• 40% faster than US/EU study startup
• 30% lower per-patient costs
• 50+ pre-qualified sites across 10 countries
• ACRP-certified clinical research professionals

Regulatory Framework

• ICH-GCP compliant execution
• FDA IDE, 510(k), De Novo, PMA, and HDE pathways
• 21 CFR 812.28 — FDA acceptance of OUS clinical data for devices
• 21 CFR 312.120 — FDA acceptance of OUS clinical data for drugs
• FDASIA Section 1123 compliance

Use Cases

• First-in-human device feasibility studies
• First-in-human drug/biologic dose-escalation studies
• Early feasibility studies under FDA IDE
• Radiopharmaceutical FIH trials

Included Activities

• Regulatory strategy and submission
• Ethics committee management
• Site selection and activation
• Patient screening and enrollment
• On-site and remote monitoring
• Data management and biostatistics
• Clinical study reports (CSR)
• FDA submission support

Client Proof Points

The site presents case studies from companies including Axoft, Newrotex, PAVmed, and Avantec Vascular, and states involvement in 15+ funding rounds by client companies.

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