Trial Master File (TMF) management is a key business focus of Phlexglobal. Our work has spanned across large and small organisations globally giving us a detailed understanding of the importance of an accurate and complete TMF to enable the evaluation of a clinical trial.

Phlexglobal supports companies with predominantly paper TMFs by providing standardisation of filing, security of filing in dedicated TMF rooms, quality control of content, TMF consolidation and archiving to ensure regulatory compliance.

We are leading the field of electronic Trial Master File (eTMF) implementation and understand the challenges of ensuring processes are effectively mapped and workflows are adapted. We have globally implemented our in-house eTMF system, PhlexEview, for a number of clients.

Taking a consultative approach, Phlexglobal is able to assess existing guidelines, processes and TMF structures and identify where process and productivity improvements can be made. We advise and assist clients in implementing changes to their TMF structures and processes where necessary.

Phlexglobal can provide the expertise and operational support to ensure the successful implementation of complete TMF Management outsourcing. Working with either PhlexEview or client-chosen systems and associated processes, we help to implement the most efficient TMF management process whilst maintaining service levels for internal customers and reducing risk for the client.