Managing Risk When Migrating Your TMF

September 07, 2022

Risked-Based TMF Quality Review: A Success Story

July 26, 2022

A biopharmaceutical company had acquired a promising compound with data from 14 clinical trials, including a critical phase III study. Only later did they discover that the Trial Master File documents were scattered across hundreds of boxes of paper and several hard drives. The company was facing critical submission deadlines and the risk of losing financial incentives related to the product acquisition – with zero insight into potential TMF quality and completeness issues that could lead to a failed inspection and delayed submission. Read the case study, “From Liability to Asset: A TMF Rescue” to discover how Phlexglobal’s unique blend of TMF expertise and services turned a “black box” into an inspection-ready TMF – ahead of schedule.

5 Reasons Your TMF Isn’t Inspection-Ready

July 20, 2022

Ensuring ongoing inspection-readiness of a Trial Master File can present challenges to even the most well-prepared organization - with unforeseen quality or completeness issues cropping up when least expected. To help identify and avoid the most common errors, Phlexglobal’s TMF experts have compiled a handy guide, “5 Reasons Your TMF Isn’t Inspection-Ready (and what you can do to fix it).” You’ll discover the top causes of inspection findings, as well as pragmatic steps to improve inspection-readiness. Want to reduce the uncertainty and risk of an inspection, and be better prepared to pass this critical test when it happens? Download the helpful guide today.