A Higher Level of TMF Quality and Completeness

Get built-in Quality Review with PhlexTMF

Quality Review in PhlexEviewPhlexTMF offers an abundance of embedded Quality Review features to help you maintain TMF Health.


In most organizations today, TMF Quality Review remains an arduous, time-consuming manual process utilizing spreadsheets and software that is not fit-for-purpose. 

eTMF solution PhlexTMF raises the standard of excellence in TMF management and oversight by providing the industry’s only embedded TMF Quality Review module. Configurable to your organization’s SOPs and study-specific parameters, the sophisticated PhlexTMF Quality Review tools let you quickly and easily conduct regular, risk-based, or milestone-driven completeness reviews within the PhlexTMF system. The result? A continually up-to-date and accurate picture of TMF health to support inspection-readiness.

By replacing manual processes and spreadsheets with Quality Review workflows and best practices built into PhlexTMF, you can improve management control and oversight of the Trial Master File from planning through archive

How can you improve Quality Review process with PhlexTMF?

  • Increase your organizational efficiency and productivity related to the TMF by managing all aspects of quality review within a single system
  • Conduct faster, easier, and more accurate quality review tailored your organization and pertinent regulatory agencies
  • Identify and resolve potential issues early in the study to eliminate cost and effort associated with rework in preparation for the inspection or end of study
  • Reduce the time and effort required to finalize and close your TMF for new applications
  • Implement a risk-based approach to TMF Quality Review in accordance with ICH E6 (R2)
  • Improve your organizational efficiency and productivity related to the TMF, streamlining cross-functional collaboration preparing for inspections


New Habits LR

How to Transform TMF Quality Guidelines into Inspection-Readiness Habits

To do inspection-readiness well and make it stick, you need a plan that goes beyond learning about the regulations and writing new procedures, more than developing metrics and creating dashboards, more than creating another online learning module. You need to consider human behavior and how we fail to develop habits that take care of our future selves, or in this case, our TMF deliverables. 

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