Phlexglobal TMF Services

Take Control of Your TMF With Our Expert Services. Stay in the TMF Healthzone with expert, scalable services from the global TMF authority

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Why Choose Phlexglobal's Clinical Services?

FREE UP YOUR INTERNAL TMF RESOURCES

Leverage seasoned Trial Master File (TMF) Study Owners anytime anywhere. Obtain pragmatic training on TMF best practices & technology. Conduct efficient, accurate TMF migrations & imports at any scale.

OPTIMIZE PROCESSES & QUALITY

Get a holistic view of completeness, timeliness & quality. Pinpoint & correct TMF completeness gaps. Embed TMF best practices around quality control & compliance. Obtain expert guidance for SOPs & eTMF technologies.

MAKE YOUR eTMF SYSTEM WORK FOR YOU

Align TMF technology with your people & processes. Leverage your eTMF to develop & automate better TMF workflows. Obtain hands-on, system-specific eTMF training. Identify what eTMF technologies can - and can’t - do well.

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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TMF Completeness Heatmaps

Easily identify potential TMF problem areas in any eTMF system and enable a risk-based remediation approach.

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TMF Quality Review

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

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TMF Document Processing

Ensure completeness, accuracy, and consistency from source to archive - regardless of your eTMF provider.

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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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TMF Consulting Services

Our expert TMF consultants help your company reach and stay in the TMF Health Zone.

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M&A Support

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

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Migrations & Imports

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

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TMF Expert Training

Generate lasting benefits to your team and improve the overall health of your TMF.

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Veeva Vault Support

Need help with Veeva Vault? Bring Phlexglobal expertise to Vault or any other eTMF tool.

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PHLEXGLOBAL EXPERTS FILL THE GAPS IN eTMF MANAGEMENT

Download our latest infographic to see how Phlexglobal’s unmatched expertise working in any eTMF system is enabling busy study teams to assess, prevent, and manage risk across the entire TMF spectrum – improvng inspection-readiness with less effort.

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Are you in the TMF Health Zone?

For inspection-readiness, the critical attributes of TMF health are completeness, timeliness, and quality. To achieve and maintain ongoing TMF health and inspection readiness – the “TMF Health Zone” – requires experienced people trained on effective processes using the right technology.

Full-Service Trial Master File Management

The Industry’s Only Turnkey, End-to-End TMF Outsourcing Solution from a Single Expert Provider.

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Latest Insights

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