One of the biggest challenges facing the industry today is the rapid and accelerating shift from paper to electronic processes in areas beyond data capture – with eTMF being a prime example. While offering significant benefits, the move to an eTMF presents many of the same data migration obstacles, such as:
As the leading authority in TMF best practices, Phlexglobal offers proven expertise in the remapping and migration of TMF documents to an eTMF, regardless of the number of TMF structures, project complexity, or source and destination systems. We are deeply engaged in the development and ongoing improvement of the TMF Reference Model (RM) and TMF RM Exchange Mechanism, and bring that knowledge to bear in every engagement.
Phlexglobal has successfully managed highly complex data migrations including the creation of one consolidated TMF from sponsor and CRO…remapping from one CRO/Sponsor TMF structure to another…and remapping and migrating from paper to the TMF Reference Model. Customers trust Phlexglobal due to our stringent quality control processes, astute use of advanced automation and digital technologies, and a precision methodology that drives efficiency without sacrificing quality.
The guide is built on Phlexglobal’s years of experience conducting hundreds of successful migrations, for organizations ranging from small biotechs to the industry’s largest sponsors and CROs. Distilling our expertise across all types of migration scenarios as well as source and destination environments, the guide offers you core best practices that streamline TMF migrations while improving quality.
The Shoulds and Shouldn’ts of Electronic Systems and Data in Clinical Trials Intro With the word should being mentioned 569 times and constituting ~7% of the content (only outweighed by data – 618
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
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