BIMO

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Pharmapace provides expert BIMO (Bioresearch Monitoring) support to ensure your clinical trial data and processes are inspection-ready. We help sponsors prepare for regulatory audits by ensuring data traceability, documentation integrity, and compliance with FDA guidelines. Our goal is to minimize risk and ensure transparency throughout your submission process.

Our services include:

• Audit readiness assessments
• Data traceability and documentation support
• Compliance with FDA BIMO requirements
• Validation of statistical outputs and programming
• Support during regulatory inspections