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HOW TO SURVIVE A TMF INSPECTION WHEN YOU'RE NOT PREPARED

You’ve just received an inspection notice, and the adrenaline is starting to kick in. When was the last completeness report? Quality review? Did the team finish the latest training on SOPs and the new eTMF system? Where to start? 

Help is here. Download “Don’t Panic: A TMF Inspection Guide for the Unprepared.” 

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At a Glance

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Phlexglobal’s Expertise Makes a Difference

Innovative Solutions

Reduces Inspection Risk

Offers Global Resources

Increase Output Speed

Brings Quality & Value

Better Value for Money

PHLEXGLOBAL'S AUTHORITATIVE TMF EXPERTISE HELPS COMPANIES ACHIEVE ONGOING TMF HEALTH AND INSPECTION READINESS

To achieve and maintain ongoing order, stability, and control over TMF health and inspection readiness – the “TMF Health Zone” – requires experienced people trained on effective processes using the right technology.

Learn More About the TMF Healthzone

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OUR DEEP BENCH OF PHLEXGLOBAL TMF EXPERTS AND INNOVATIVE eTMF TECHNOLOGY HAVE HELPED COMPANIES LIKE YOURS PREPARE FOR AND SUCCESSFULLY PASS HUNDREDS OF INSPECTIONS WORLDWIDE

Technology and Services

Phlexglobal leverages dedicated and authoritative TMF technologies and expert services to bring order, stability, and control to your Trial Master File – helping you achieve the highest standards for completeness, timeliness, and quality.

TMF Technology TMF Services

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Phlexglobal Provides Unmatched TMF and Document Management Expert Services

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TMF Quality Review

A thorough quality assessment of your TMF, giving you insight into its quality and completeness

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TMF Heatmaps

Easily identify potential TMF problem areas and enable a risk-based remediation approach

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Migrations & Imports

Help ensure you are meeting GCP standards and regulatory requirements for essential documents

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Mergers & Aquisitions

Get a true picture of your acquired drug’s readiness for inspection or submission – and fix any problems

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TMF Study Owners

Our TMF practitioners have successfully mastered the challenges you and your teams face every day

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And Much More

Continue here to find out how to stay in the TMF Healthzone with expert, scalable services from the global TMF authority

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Reduce TMF Misfiles with Next-Generation AI

Latest Insights

Check out our blogs, webinars, articles and more. Connect with our experts and stay up-to-date on all of the trends in the pharmaceutical, biotech and medical device industries.

Entering the Post-Paper Realism: The Principles of Cyber Ethics

The Shoulds and Shouldn’ts of Electronic Systems and Data in Clinical Trials Intro With the word should being mentioned 569 times and constituting ~7% of the content (only outweighed by data – 618

Overcoming TMF misfiles and metadata errors to reduce inspection risk

Trial master file misfiles are a common occurrence, with as many as one in every 10 documents being misfiled.   In some ways, misfiles are an even greater issue now with eTMF systems, where filing is

TMF Management in Clinical Trials Blog 3: Running the Trial in Your eTMF

Introduction Well, first and foremost, welcome!   Rob Jones has relinquished control and I’ve been given free rein to bring you the last blog in the series on TMF Management in Clinical Trials. Those