On June 24, 2021, I was honored to moderate a dynamic roundtable discussion with an outstanding group of industry ...

Adapted from a Phlexglobal Innovation Tour webinar, “Crossing the TMF Compliance Gap with Inspection-Ready Access for ...

Adapted from a Phlexglobal Innovation Tour webinar, “Streamlining TMF Documentation through Clinical Automation,” held ...

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

Regulators have made it abundantly clear, through recent guidance and inspection findings, that compliance ...

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 ...