TMF migrations and 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:

• 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?

Our expertise in TMF remapping and migration

As a leading authority in TMF best practices, we offer 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 CDISC TMF Reference Model (RM) and the CDISC TMF RM Exchange Mechanism, and apply that knowledge to every engagement.

We have successfully managed highly complex data migrations, including the creation of one consolidated TMF from sponsor and contract research organization (CRO), remapping from one CRO/Sponsor TMF structure to another, and remapping and migrating from paper to the TMF Reference Model. Customers trust us 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.