Preparing for a clinical trial data audit can be a daunting task for sponsors, particularly with escalating data sources, enormous protocol complexities, outsourced vendor data, and changing regulations such as ICH E6(R2).
According to the FDA, data management guidelines for good clinical practice cover both quality control and quality assurance systems and processes in an effort to prevent errors and provide mechanisms for accurate audit trails and validation.
In this webinar, sponsors and CROs will learn how to improve trial data management, meet compliance requirements, and address complexity.
