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

Artificial Intelligence (AI) continues to make strides in the life sciences regulatory arena, but many obstacles ...

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

Adapted from the Phlexglobal Innovation Tour virtual panel discussion, “Innovation on IDMP / Data Preparation,” held ...

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 ...