TMF Quality Review: Identify and Mitigate Compliance Risk

Avoid unnecessary delays, cost, and effort with review by the industry’s leading TMF experts


Improve Inspection-Readiness and Reduce Potential Regulatory Risks

Phlexglobal’s TMF Quality Review (sometimes called a “file review”) provides a line-by-line evaluation of your TMF, giving you detailed insight into its quality, completeness, and timeliness. Much more than just a series of TMF data reports, the customer-proven review is conducted by our expert TMF practitioners with deep understanding of current inspection standards at each major regulatory agency.

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Benefits of Phlexglobal’s Expert TMF Quality Review

Drawing on Phlexglobal’s global leadership in Trial Master File best practices and experience conducting hundreds of TMF quality reviews, our proven process helps ensure your TMF meets GCP standards and regulatory requirements:

  • Comprehensive analysis of individual studies as well as trend analysis across studies
  • Innovative, purpose-built tools such as TMF heatmaps
  • Risk-based assessments to quickly pinpoint and drill down to problem areas
  • Logic checks and cross-checks to validate the quality of individual documents and whether documents all relate to each other properly
  • Flexibility to be used with any eTMF system in addition to Phlexglobal’s advanced eTMF software, PhlexTMF
  • Detailed, expert recommendations for necessary remediation

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5 of the Top 10
Global Pharma

Are leveraging Phlexglobal's TMF Quality Review to reduce time, cost, and potential risks from M&A activity

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CASE STUDY: Phlexglobal Quality Review Helps Save Billion-Dollar Marketing Submission for an Acquired Compound

Phlexglobal A TMF Rescue White Paper


From Liability to Asset: A TMF Rescue

A Case Study on the Importance of TMF Health

Learn how Phlexglobal helped a global biopharmaceutical company quickly turn a poor-quality Trial Master File into an inspection-ready asset
Download the Case Study

Get the Insight You Need to Improve TMF Health and Inspection-Readiness

Phlexglobal’s TMF Quality Review easily pinpoints key patterns and problem areas, further filtering the detailed review data to gain actionable insight for remediation. We can also able to take a functional service approach to the Quality Review, focusing on those areas where you don’t have internal expertise, or where you have already identified areas requiring deeper evaluation.

TMF Heatmap - 1

Detailed heatmaps are just one of the advanced tools utilized by Phlexglobal’s experts to help assess the quality of your TMF.

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Get the Details - Download the Quality Review Data Sheet! 

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It's time to raise your standard 

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Latest News

A Blueprint for Genuine Partnership in TMF Improvement

The Trial Master File (TMF) has evolved from a repository of documents at the end of a study to an integral cog in the regulatory journey. This has led some companies to shift their perspective from

Rewind the clock and take TMF back to basics

Rewind the clock and take TMF back to basics: The paradigm of maintaining simplicity while embracing technology. In 20 years, the Trial Master File (TMF) has moved from paper in dusty lever arch

How to Reduce Risk and Effort When Migrating a Trial Master File

Migrating Trial Master File (TMF) data is a fairly common occurrence, usually driven by one or more of the following scenarios: Implementing a new electronic Trial Master File (eTMF) system