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

Smart Steps to Managing Your TMF Audit Trail

The term audit trail can be daunting for companies, but this is a regulatory requirement. Simply put, when it comes to the trial master file (TMF), if an action is not recorded in the audit trail,

Lowering the TMF temperature through quality reviews

We are thrilled to announce Season 2 of our exciting webinar program, Summer Shorts: TMF Excellence Edition! Avoid boring summer reruns and attend these fresh, informative sessions where our experts

Five-step Game Plan for a TMF Close-out

Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or