The company had acquired a promising compound with data from 14 clinical trials, including a critical phase III study. During NDA preparations, they discovered that the Trial Master File for these studies was scattered across hundreds of boxes of paper and several hard drives. What’s more, the company did not know what was in the TMF – much less what essential documents might be missing that would lead to a failed inspection and delayed submission.
Facing key submission deadlines, the company was unsure of the next step. They did not have the internal TMF expertise and resources to make the TMF inspection-ready, even if time was not a factor – and neither did their CROs.
Phlexglobal’s unique balance of document processing expertise, scalable global resources, and advanced technologies
After having no success with their usual service providers, the biopharmaceutical company turned to Phlexglobal, the global authority in Trial Master File software and services. The document experts at Phlexglobal quickly scoped the project and were convinced they could deliver an inspection-ready TMF in the time allowed – which was fast running out.