Take Control of Your TMF.

Expert, scalable services from the TMF experts.

Phlexglobal has been a leader in Trial Master File strategies and solutions for decades. We know the ins and outs of not just creating feature-rich software, but making sure it runs effectively and efficiently on whatever IT infrastructure you’re working with.

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What can Phlexglobal services do for your organization?

Free up your internal TMF resources

Leverage seasoned Trial Master File Study Owners anytime, anywhere. Get practical training on TMF best practices and technology. Conduct efficient, accurate TMF migrations and imports at any scale.

Optimize processes & quality

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

Make your eTMF system work for you

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

Phlexglobal eTMF Services

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Document Processing

Ensure completeness, accuracy, and consistency at every step—including Paper Digitization, Index & QC, and Classify & Approve—regardless of your eTMF provider.

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Veeva Vault Support

We draw on experience from dozens of Vault-related projects each year to address your specific situation and strategic goals.

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TMF Completeness Heatmap Analysis

Easily identify potential TMF problem areas in any eTMF system, and enable an informed risk-based review and remediation approach.

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TMF Quality Review

Get a thorough quality assessment of your TMF, delivering detailed insight into quality and completeness.

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TMF Study Resources

Our TMF practitioners have successfully mastered the challenges you and your teams face every day—and are happy to share their expertise.

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TMF Expert Training

Bring your team fully up to speed and generate lasting benefits that can improve the overall health of your TMF.

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TMF Consulting Services

Expert TMF consultants with extensive real-world experience can 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 that may stand in our way.

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Migration & Imports

Find all the backup you need to ensure you’re meeting GCP standards and regulatory requirements for essential documents.

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Do you know where your gaps are?

Download our infographic to see how Phlexglobal’s unmatched expertise working with countless eTMF systems enables busy study teams to assess, prevent, and manage risk across the entire TMF spectrum—and improve inspection readiness with less effort.

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Get in the Health Zone.

The critical attributes for inspection-readiness are completeness, timeliness, and quality. Find out what it takes to reach the TMF Health Zone—and how you can stay there.

Get in the zone.

PhlexTMF+ Circle GraphicExplore PhlexTMF+ full-service Trial Master File management.

Take advantage of the industry’s only turnkey, end-to-end TMF outsourcing solution from a single expert provider.

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TMF Expertise In Action

Connect with Phlexglobal experts and stay up-to-date on the latest pharmaceutical, biotech and medical device industry trends.

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

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It's time to raise your standard.

Contact us today.