Amersham, UK; Malvern, PA. — June 20, 2019 — Phlexglobal today announced an important industry advisory around the new European Medicines Agency (EMA) guidance on Trial Master Files. The guidance took effect on June 6, 2019, and promises to have far-reaching impacts on an organization’s TMF processes, technology, and best practices – as well as related departments and systems.
The TMF community recently came together in Denver for the CDISC US Interchange, and members of the Phlexglobal team came home with plenty to reflect on. Across sessions, hallway discussions, and
CDISC US was a great opportunity to meet customers, colleagues, and fellow industry experts face to face – both for the first time and re-connecting after a year or more away. There was a fantastic
When my Trial Master File (TMF) career began, the TMF Reference Model did not exist. Every customer had a different way of organising the contents of their TMF, and it was rarely interpreted
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