Ensure Inspection-Ready Access to TMFs from Closed and Locked Studies
SOFTWARE FILLS CRITICAL “COMPLIANCE GAP” IN THE TRIAL MASTER FILE LIFECYCLE
PhlexTMF for Viewing answers a pressing need in the industry for easily inspectable storage of the TMF after the study is closed or locked. Few CROs offer compliant maintenance of the Trial Master File after study closeout, usually returning the eTMF on unsecure and hard-to-track media such as USB drives or even printed out. These Trial Master Files are difficult to review and inspect, and force sponsors to keep their own study documents separate. Sponsors had limited options for compliance with regulatory requirements – until now.
PhlexTMF for Viewing answers that pressing need with secure, compliant, cloud-based TMF storage for closed and locked studies.