By Karen Redding, Global Business Development Director, Phlexglobal, Ltd.
Phlexglobal, the TMF experts, have developed PhlexEview, an electronic Trial Master File system that supports efficient management and tracking of TMF content throughout the lifecycle of a clinical trial. PhlexEview transforms costly, stagnant, paper-based processes into dynamic, value driven compliance programs by capturing, tracking and managing global TMF activities and enabling unprecedented access to trial content throughout the conduct of the study. Compliance is always the most critical factor when designing an approach to TMF management. But that doesn’t mean that an organisation has to spend time and money managing paper that doesn’t support global access, collaboration or compliance efforts.
PhlexEview supports compliance and collaboration by leveraging industry standards and making TMF content available to users, regardless of their location. The ability to access and view TMF content at any time transforms sluggish and inert paper processes and helps organisations to realize time and cost savings by reducing travel costs, positioning team members to proactively identify compliance issues and implement corrective actions and by facilitating global collaboration.
This paper discusses some of the challenges of traditional paper-based TMFs and provides details about PhlexEview, Phlexglobal’s eTMF system. It also suggests a new approach to TMF compliance that extracts and sets the expectation for continuing value from TMF content, rather than locking it away in paper storage where its value is minimized.