Regulatory agencies are increasingly looking at the TMF audit trail to gain greater insight into data integrity. We ...

Trial Master File (TMF) quality control is a topic that always seems to be present on conference agendas and it invokes ...

On April 16, 2020, the US Food & Drug Administration (US FDA) released an update1 to its March 2020 guidance on the ...

In early October, Phlexglobal was honored to welcome industry TMF professionals from over thirty pharmaceutical ...

You’re responsible for preparing your Trial Master File for an upcoming inspection or audit. You’ve inherited some TMFs ...