New Phlexglobal Solution Offers Easy TMF Inspection of Closed Studies, Addressing a Critical Compliance Gap in the Trial Master File Lifecycle

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PhlexTMF for Viewing offers secure, accessible and fully compliant cloud-based TMF storage for closed and locked studies received from a CRO or third party.

“PhlexTMF for Viewing is an outstanding example of how Phlexglobal’s deep TMF and regulatory subject matter expertise, backed by our advanced software development team, is delivering genuine innovation." John McNeill Chief Executive Officer of Phlexglobal.

Phlexglobal announced today the launch of PhlexTMF for Viewing, an innovative solution addressing the growing industry need for easily inspectable storage of the Trial Master File after a study has been closed or locked. Maintaining access to Trial Master File content for internal review and regulatory inspection after study completion is critical to effective compliance, and until now sponsors had limited options available to them. PhlexTMF for Viewing closes this “compliance gap” by providing secure and easy eTMF access to closed studies from anywhere at any time, in an intuitive user interface.

“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

On April 21st, Phlexglobal will host a complimentary webinar "Crossing the TMF Compliance Gap with Inspection-Ready Access for Closed Studies" which will explore how this solution can help pharmaceutical companies meet this challenge. Complimentary registration is available at https://www.phlexglobal.com/phlextmf-for-viewing.

“PhlexTMF for Viewing is an outstanding example of how Phlexglobal’s deep TMF and regulatory subject matter expertise, backed by our advanced software development team, is delivering genuine innovation,” said John McNeill, Chief Executive Officer of Phlexglobal. “We are pleased to provide this practical and effective solution to a critical compliance need for our industry.”

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Christopher D Englerth
Phlexglobal
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