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:

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.
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.
How Senior TMF Study Owners bridge strategy, mentoring and operational delivery. What does it really mean to have an expert in your corner when it comes to your Trial Master File? For organisations
The critical role TMF Study Owners play in driving inspection readiness. The Cost of an Afterthought In the fast-paced environment of a clinical trial, where multiple activities unfold in parallel,
Why TMF Administrators are becoming essential to scalable TMF operations. The Invisible Engine Behind Every Healthy TMF Clinical trials are complex. Sponsors are under pressure. Timelines are tight.
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