Migrate Your TMF with Absolute Confidence

Precise, proven methodology delivers highly efficient TMF migration, without sacrificing quality

Case Study

They didn't believe it could be done...

  • Process mapping and re-engineering of workflow requirements
  • Complete restructuring of the TMF
  • Streamlining current processes and implementing secure storage
  • Managing CRO partnerships and effective processing of over 250,000 retrospective documents into the eTMF
  • A deadline in weeks, not months

Phlexglobal did it. 

TMF Migrations & Imports

Maintain the accuracy and integrity of your TMF data at every step

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:

  • How do you ensure data integrity and compliance during this change?
  • What is the best way to manage legacy data?
  • How will migration impact our people, processes, and timelines?
  • What is industry best practice for integrating data from different sources and systems, including multiple Trial Master Files and different file structures?
  • How do you balance the need to migrate data quickly with effective quality control?

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.

From Chaos to Order in 3 Steps - Phlexglobal Guide to Planning TMF Migration_Page_1

From Chaos to Order: Your Expert Guide to TMF Migration Planning

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.

Get the Guide
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