TMF Quality Review: Identify and Mitigate Compliance Risk

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

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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
 Companies

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 a 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
 
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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 

CONTACT PHLEXGLOBAL TODAY
 
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Latest News

Smart Steps to Managing Your TMF Audit Trail

The term audit trail can be daunting for companies, but this is a regulatory requirement. Simply put, when it comes to the trial master file (TMF), if an action is not recorded in the audit trail,

Lowering the TMF temperature through quality reviews

We are thrilled to announce Season 2 of our exciting webinar program, Summer Shorts: TMF Excellence Edition! Avoid boring summer reruns and attend these fresh, informative sessions where our experts

Five-step Game Plan for a TMF Close-out

Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or