Big Leap Research recently organized a professional sharing session with Dr. Naoki Tsutsumi, focusing on two key areas: ICH-GCP E6(R3) and “Inspection Readiness – What Inspectors Really Look For.”
Dr. Naoki highlighted key updates in E6(R3) compared to R2, with emphasis on risk-based approaches, stronger quality management, and clearer accountability across trial processes.
The session on Inspection Readiness focused on what inspectors actually review, including consistency between data and documentation, robustness of SOP systems, and common audit findings at site level.
Through these activities, Big Leap Research continues to strengthen team capabilities and ensure high-quality, compliant clinical research execution.
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