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.

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.

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