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