Clinical Document Management Fact Sheet

Every year, sponsors invest millions of dollars to improve efficiency and reduce the expenses associated with clinical trials. Management of essential trial documentation is indisputably one of the most time-consuming and expensive components of conducting a clinical trial.

ICH E6 guidance specifies over 200 documents that must be managed before, during, and after a trial. All of these documents must be available for audit by the sponsor and for inspection by regulatory authorities. Yet, despite the resources and risks involved, the trial master file is still often managed manually, with documents scattered across hundreds or thousands of locations. This decreases operational efficiency, raises costs, creates a risk of regulatory non-compliance, and results in approval delays.

The NextDocs eTMF solution incorporates lessons learned and best practices in clinical document management across the life sciences industry. It also includes a comprehensive document inventory based on the Reference Model on the DIA website, which was developed by an industry working group.