Phlexglobal to Improve eTMF Document Transfers with Adoption of New Exchange Mechanism Standard

Karen Roy Cropped
"Combined with Phlexglobal’s industry-leading expertise in TMF management, the eTMF-EMS will enable us to migrate TMF data in a variety of situations with a minimal amount of manual work.”

-Karen Roy, Chief Strategy Officer, Phlexglobal

News

 

AMERSHAM, UK, June 21, 2018 - Phlexglobal, a specialist provider of technology-enabled Trial Master File (TMF & eTMF) management solutions, is adopting Version 1 of the eTMF Exchange Mechanism Standard (eTMF-EMS) of the TMF Reference Model (TMF-RM) into PhlexTMF, the company’s eTMF technology. This marks a major advancement in efficient document interchange and will firmly solidify Phlexglobal’s position as a driving force in eTMF management for clinical trials.

Prior to the creation of the TMF Reference Model, there was no universal methodology for the organization of trial data in an eTMF. In 2009 Phlexglobal joined other industry TMF experts to create the TMF Reference Model which has primarily focused on organizing the artifacts of a clinical trial.

While the TMF-RM has aided in the organization of artifact, the transfer of TMF to trial sponsors or contract research organizations has often required a significant amount of mapping and manipulation. Phlexglobal has extensive experience migrating millions of TMF documents across countless systems. The Exchange Mechanism Standard facilitates the transfer of this data, and by adopting it Phlexglobal will bring order to the interchange of trial master file content, metadata, audit trail and electronic signature information between organizations and systems. Phlexglobal is an active contributor in the eTMF-EMS development, providing valuable insight to the collaborative effort.

 

Digital Brain Header Large Brain Right

It's time to raise your standard 

CONTACT PHLEXGLOBAL TODAY
 
Contact Us

Latest News

Overcoming TMF misfiles and metadata errors to reduce inspection risk

Trial master file misfiles are a common occurrence, with as many as one in every 10 documents being misfiled.   In some ways, misfiles are an even greater issue now with eTMF systems, where filing is

TMF Management in Clinical Trials Blog 3: Running the Trial in Your eTMF

Introduction Well, first and foremost, welcome!   Rob Jones has relinquished control and I’ve been given free rein to bring you the last blog in the series on TMF Management in Clinical Trials. Those

TMF Management in Clinical Trials Blog 2: The Path to Metric Nirvana

Good morning, good afternoon, good evening (I like to cover every possibility because who knows when you are reading this)! I hope you all enjoyed part one of this series where we talked about the