In today’s ACT Brief, we examine what changes when AI is embedded across clinical operations, why faster trial data isn’t yet producing faster decisions, and how FDA granted accelerated approval to a therapy for a rare airway disease.
|Articles|July 26, 2022
Risked-Based TMF Quality Review: A Success Story
Author(s)Phlexglobal
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.
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