Phlexglobal Issues Industry Advisory on New EMA Trial Master File Guidance

Comprehensive guidance took effect June 6, 2019; will significantly impact sponsor and CRO compliances

shutterstock_679945117

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.

 

 

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