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?
At a Glance
Phlexglobal’s Expertise Makes a Difference
Reduces Inspection Risk
Offers Global Resources
Increase Output Speed
Brings Quality & Value
Better Value for Money
Improve productivity and inspection-readiness with expert guidance on TMF best practices and fast, accurate processing services to enhance and augment your own internal resources.
Increase efficiency, accuracy and consistency from plan to final archive by applying the right mix of technology and services based on your organization’s unique TMF needs and requirements.
Industry's only next-gen eTMF AI ready on Day One to reduce TMF inspection risk and increase team productivity.
Purpose-built eTMF Software. Improve inspection-readiness with software built on TMF best-practices.
Viewable, inspectable eTMF archive for closed studies from your CRO. Fill the gap in the Trial Master File Lifecycle.
Phlexglobal Provides Unmatched TMF and Document Management Expert Services
TMF Quality Review
A thorough quality assessment of your TMF, giving you insight into its quality and completeness
Easily identify potential TMF problem areas and enable a risk-based remediation approach
Migrations & Imports
Help ensure you are meeting GCP standards and regulatory requirements for essential documents
Mergers & Aquisitions
Get a true picture of your acquired drug’s readiness for inspection or submission – and fix any problems
TMF Study Owners
Our TMF practitioners have successfully mastered the challenges you and your teams face every day
And Much More
Continue here to find out how to stay in the TMF Healthzone with expert, scalable services from the global TMF authority
Reduce TMF Misfiles with Next-Generation AI
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TMF Management in Clinical Trials Blog 3: Running the Trial in Your eTMF
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