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.
Phlexglobal provides a unique Trial Master File solution by leveraging dedicated and authoritative TMF technologies and expert services to bring order, stability, and control to your Trial Master File – helping you achieve the highest standards for completeness, timeliness, and quality.
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E-Mail: info@phlexglobal.com