Preparing for a Clinical Trial data audit can be a daunting task for sponsors, particularly with escalating data sources, enormous protocol complexities, inclusion of outsourced vendor data and changing regulations such as ICH E6 (R2).
According to the FDA, GCP data management guidelines cover both Quality Control and Quality Assurance systems and processes. They include guidance to prevent errors and to provide mechanisms for accurate audit trails and validation.
In this webinar, Comprehend discusses Five Best Practices to help sponsors and CROs improve trial data management, meet compliance requirements and address complexity with ease.