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 will discuss Five Best Practices to help sponsors and CROs improve trial data management, meet compliance requirements and address complexity with ease. The presentation will answer questions such as:
|"How can I see and resolve issues across studies?"
"How can I close queries faster?"
"How can I resolve shared issues with my CRO?"
"How can I track and report on quality metrics?"
Join us for this informative session for an overview on how to handle data issues before they cause audit problems. Following the presentation, we’ll provide a short demonstration of how to apply automation to manage these data issues.