Will Your Acquired Compound Pass Inspection?

Paper or digital, Phlexglobal can fix a faulty TMF


Avoid application delays and challenges by getting a true picture of a therapy’s inspection-readiness

In today’s pharmaceutical M&A environment, compounds or molecules that have been through clinical development – sometimes years previously – often end up with new owners. And while the science and market rationale behind these acquisitions are the focus, much less attention is paid to an important practical question: What is the state of the Trial Master File?

Thanks to Phlexglobal’s authoritative TMF expertise and our mastery of eTMF technologies, you can now easily get a true picture of your acquired drug’s readiness for inspection and/or submission.  Whether you’ve received hundreds of boxes of paper documents, gigabytes of data, or some combination, Phlexglobal is the recognized leader in rapidly and accurately converting this often chaotic documentation into a high-quality, inspection-ready TMF.


Contact Us

Discover why several Top 50 pharmaceutical companies have turned to Phlexglobal to successfully review and validate TMF documentation for acquired drugs, placing their trust in our proven end-to-end process:

  • Complete inventory of all content and rapid, accurate conversion of documentation to usable, digital format aligned with the TMF Reference model
  • Detailed Quality Review of all documentation, with high-level heatmaps for executive overview and granular line-by-line detail for taking action
  • Full gap analysis to identify missing documentation, together with a risk-based remediation plan
  • Visibility to progress throughout the conversion to the TMF, with early identification and prioritization of critical items for corrective action

Case Study


Accelerated Processing

Reducing time to a submission-ready TMF from six months to nine weeks

Phlexglobal helped a Top 20 US pharmaceutical company submit their NDA for an acquired drug weeks ahead of schedule, successfully converting 500 boxes of paper and 500GB of documents – and in 65% less time than the customer anticipated.

Complexity? Our Specialty

Successfully converting >1 million pages of documents from different CROs and in multiple TMF structures

A Top 20 European pharmaceutical company thought they had 250,000 pages of documentation from an acquired drug. It was actually more than one million pages. Even with this 300% increase in scope, Phlexglobal was able to meet their original schedule for building an inspection-ready Trial Master File.

Digital Brain Header Large Brain Right

It's time to raise your standard 

Contact Us

Latest News

Clinical Trials & the TMF 101 - Blog 4: The TMF Trinity

Introduction We have been on a journey you and me, we started off by understanding the purpose of a clinical trial and the multiple phases to get products to market. We then looked at the Trial

Clinical Trials & the TMF 101 - Blog 3: Paper vs Electronic, why it is more than a DMS

Introduction Awww it warms my heart you came back to read the third blog. I hope you are finding these helpful, don’t forget to send any of your feedback or questions to rtjones@phlexglobal.com. We

Clinical Trials & the TMF 101 - Blog 2: What is this TMF you speak of?

Introduction You came back, great! I hope you enjoyed our first blog in this series which was all about the basics of a clinical trial. In this blog we are going to get into the Trial Master File,