“Today, most providers return the final eTMF to sponsors on unsecure and hard-to-track media such as USB drives or even printed out, making the TMF extremely difficult to review and inspect,” said Jim Nichols, Chief Product Officer at Phlexglobal. “This also forces sponsors to keep their own study documents separate from the study’s eTMF, adding unnecessary time and effort to compliance activities.”
PhlexTMF for Viewing solves these challenges by allowing sponsors to take closed eTMFs from their CRO or eTMF vendor and easily make them available for internal use and inspections. Documents are maintained in a secure, cloud-based system built for contextual TMF navigation with multi-attribute searching capabilities, and sponsors can add related documents directly into the software.
A complete solution, PhlexTMF for Viewing provides everything required to manage an eTMF received from a third party, including:
- Advanced PhlexTMF for Viewing software, with flexible subscriptions to align with typical inspection timeframes and a company’s own requirements
- Phlexglobal-managed import of TMF documents, metadata, and audit trail into PhlexTMF for Viewing
- Account creation, management, and training for sponsors and inspectors
- Simplified transition to long-term archive when needed