First-in-Human FIH-12™ — Clinical Data in 12 Months Guaranteed — bioaccess®

bioaccess® states that FIH-12™ is the only FIH clinical trial program with a 12-month timeline guarantee. The program uses a 9-component clinical development methodology designed to deliver first-in-human data meaningfully faster and at lower cost than US/EU pathways.

Program Components

• Regulatory strategy and pre-submission
• Parallel ethics and regulatory filings
• Pre-qualified site activation
• Accelerated patient enrollment
• Real-time remote monitoring
• Streamlined data management
• FDA bridge data package preparation

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