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.
The Shoulds and Shouldn’ts of Electronic Systems and Data in Clinical Trials Intro With the word should being mentioned 569 times and constituting ~7% of the content (only outweighed by data – 618
Trial master file misfiles are a common occurrence, with as many as one in every 10 documents being misfiled. In some ways, misfiles are an even greater issue now with eTMF systems, where filing is
Introduction Well, first and foremost, welcome! Rob Jones has relinquished control and I’ve been given free rein to bring you the last blog in the series on TMF Management in Clinical Trials. Those
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