SOPs for BA-BE Studies V 2.0

To define the process for planning, monitoring, and managing study timelines and key milestones in Bioavailability/Bioequivalence (BA/BE) studies to ensure adherence to project deadlines, resource coordination, and regulatory deliverables.
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To define the procedure for establishing and maintaining an Electronic Trial Master File (eTMF) system for BA/BE studies, ensuring real-time documentation, compliance with ICH-GCP guidelines, and audit readiness.
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To establish a structured approach for the identification, assessment, documentation, and mitigation of project risks in Bioavailability/Bioequivalence (BA/BE) studies, ensuring study continuity, data integrity, and regulatory compliance.
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To define the process for registering BA/BE clinical trials in the European Clinical Trials Database (EudraCT) in accordance with European Medicines Agency (EMA) requirements for transparency, regulatory compliance, and study oversight.
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To define the process for implementing and ensuring compliance with the ICH E6(R2) Good Clinical Practice (GCP) Addendum requirements in Bioavailability and Bioequivalence (BA/BE) studies, with specific focus on quality management, sponsor oversight, and risk-based monitoring.
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To define the procedure for reviewing and aligning with current regulatory guidelines before the initiation of Bioavailability/Bioequivalence (BA/BE) studies to ensure protocol design, conduct, and reporting are compliant with applicable global regulations.
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