TMF and GCP Compliance

Are your practices for handling TMFs compliant with the new GCP requirements from ICH E6 (R2) coming into effect June 14? Background for ICH E6 (R2) The ICH GCP E6…

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Organizational Change Strategies for Sustainable Trial Master File Management

Are you or your colleagues facing never-ending issues when being audited or inspected? It might be time to start putting your (clinical) house in order.

Be a Good Student: Get Your eTMF Prepared

Preparation is key to pass your Good Clinical Practice (GCP) inspection. You need to prepare well in advance and certainly not shortly before.