To Improve Real-Time Visibility of Clinical Trial Documentation and Inspection-Readiness
Veristat has completed the validation and configuration of Master Control’s eTMF system, which is now implemented and available for Veristat managed clinical trials.
Veristat selected the Master Control eTMF because an eTMF software system provides an industry best practice approach to document management which allows us to efficiently manage our sponsor’s clinical trials. MasterControl's eTMF software systems are designed to effectively manage eTMF documents and integrate them with other quality processes critical to regulatory compliance. Configuration is based on the Drug Information Association (DIA) Reference Model. Using this model will increase consistency and provide a central location for all required TMF documents.
According to the 2017 Veeva Clinical Operations Survey, eTMFs are among the third most frequently used clinical trial applications behind Electronic Data Capture Systems (EDC) and Clinical Trial Management Systems (CTMS). Additionally, nearly one in three (31%) sponsors now use eTMFs because they have found that eTMF applications have a “positive impact on inspection-readiness and improve activities key to unifying clinical operations” (2017 Veeva Clinical Operations Survey).
What is an eTMF?
An eTMF is a trial master file (TMF) in electronic format which contains the essential documents, images or other digital assets associated with a clinical trial which must be stored in compliance with global regulations and guidelines for the conduct of a Clinical Trial. In addition to containing adequate and accurate clinical trial data & documentation, an eTMF must be organized in a manner suitable for sharing that information among internal and external clinical study team members, and with regulatory agency inspectors.
What are the benefits of using an eTMF for my clinical trial?
The greatest benefit of utilizing eTMFs as part of a clinical trial as reported by Sponsors is that it improves efficiency during the conduct of a trial, and can assist with audit or inspection readiness (2017 Veeva Clinical Operations Survey). Additional benefits cited by sponsors include improved automated tracking of trial documentation, easier collaboration between clinical project team members, sites and vendors, improved central or remote auditing, and overall time and costs savings in running a trial.
Want to Learn More about Master Control eTMF?
To learn more about the Master Control eTMF system that Veristat just launched, visit the Master Control website.
To learn more about how Veristat can help design and manage your clinical trial utilizing the Master Control eTMF, contact Veristat.