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.
5of the Top10 Global Pharma Companies
Are leveraging Phlexglobal's TMF Quality Review to reduce time, cost, and potential risks from M&A activity
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 [link to https://www.phlexglobal.com/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 [link to https://www.phlexglobal.com/phlextmf]
Detailed, expert recommendations for necessary remediation
CASE STUDY: Phlexglobal Quality Review Helps Save a Billion-Dollar Marketing Submission for an Acquired Compound
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
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.
Detailed heatmaps are just one of the advanced tools utilized by Phlexglobal’s experts to help assess the quality of your TMF.
