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

home__library_couch
“Duis mollis, est non commodo luctus, nisi erat porttitor ligula, eget lacinia odio sem nec elit. Cras mattis consectetur purus sit amet fermentum. Sed posuere consectetur est at lobortis. Donec ullamcorper nulla non”

Jason Doeson
Computer Science Graduate of 2015

Phlexglobal Logo-no tagline

 

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

Clinical Trials & the TMF 101 - Blog 4: The TMF Trinity

Introduction We have been on a journey you and me, we started off by understanding the purpose of a clinical trial and the multiple phases to get products to market. We then looked at the Trial

Clinical Trials & the TMF 101 - Blog 3: Paper vs Electronic, why it is more than a DMS

Introduction Awww it warms my heart you came back to read the third blog. I hope you are finding these helpful, don’t forget to send any of your feedback or questions to rtjones@phlexglobal.com. We

Clinical Trials & the TMF 101 - Blog 2: What is this TMF you speak of?

Introduction You came back, great! I hope you enjoyed our first blog in this series which was all about the basics of a clinical trial. In this blog we are going to get into the Trial Master File,