Are Resource Constraints Impacting TMF Health?

Quickly expand your internal TMF resources with anytime, anywhere TMF expertise


Phlexglobal TMF Study Owners

Discover why customers rely on Phlexglobal to enhance their TMF Resources

With sponsors facing increasing resource constraints, and CROs struggling to maintain TMF expertise in-house, the TMF has increasingly become a source of added study cost and delay – as well as potential delay or failure of the NDA. 

Phlexglobal helps eliminate these resource risks and help ensure the ongoing health of your TMF project by easily expanding and enhancing your internal TMF capabilities with highly experienced TMF practitioners.


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Our TMF practitioners have successfully mastered the challenges you and your teams face every day, averaging 10 years of hands-on experience conducting clinical trials, building TMF processes and SOPs, leading document management teams, implementing regulatory updates, and aligning eTMF technology to business processes.


With one of the largest teams of seasoned TMF professionals in the industry, backed by our tightly aligned in-house services, operations, and technology teams, Phlexglobal offers you TMF expertise that can scale rapidly to any project, anywhere in the world and at any time—regardless of your projects size, complexity, or duration.



Phlexglobal’s TMF Study Owner model provides you with unique flexibility to meet your particular requirements. We have provided everything from a single TMF professional for a two-week engagement at a small biotech and embedded TMF teams to some of the world’s largest pharmaceutical companies and CROs for multi-year engagements. 

Proven Value

We have helped customers improve ongoing inspection-readiness and meet “impossible” deadlines. Phlexglobal frees up internal resources to do more with less and increases your TMF capabilities with a minimal effort.

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Latest News

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

Key Trends and Hot Topics from the Fierce TMF Summit US

Introduction: Trial Master File (TMF) experts are acutely aware of the growing complexity involved in meeting compliance obligations and improving overall quality and completeness. As those working

Staying on Top of the Trial Master File

As regulatory agencies increasingly focus on the processes and workflows behind the Trial Master File (TMF), not just on what it contains, the pressure has increased on sponsors to ensure theirs is