How Quality Review And Heatmaps Can Reduce Remediation Time, Cost, And Effort For An Acquired Trial Master File

As mentioned before in this blog series, an acquired Trial Master File (TMF) requires special attention to ensure that essential content is available, documented, and organized appropriately. A deeper analysis of the TMF and its components is likely necessary to ensure inspection-readiness. However, the analysis should provide tactical and strategic insights so your team can reflect on it, take action, and communicate the strategies and remediation plans to management and other functional areas within your organization.    

Phlexglobal recommends two expert methodologies and tools that help TMF owners establish the current state of the TMF, and better understand what steps are needed to maintain compliance: TMF Quality Review and TMF Heatmaps.