In early 2021 the TMF Reference Model working group reported back on “Guidance for the Management of e-Mail Communications in Clinical Studies”. The team eloquently explained their 15 months of diligent and valuable work - I say thank you to lead authors Jamie, Russell, Mark and the other contributors.
Across the spectrum of eClinical, sponsors and CROs have deployed a myriad of emerging and established technology - from EDC to IxRS. The electronic Trial Master File is no exception.
Like so many of us, I’ve spent a good chunk of time in recent months on industry webinars - it’s so good to hear of the new ideas and innovations happening in many places. It also helps one reflect on the assumptions present in one’s own world that aren’t necessarily obvious to others.
In a business niche as highly critical, closely scrutinised and heavily regulated as pharmacovigilance it remains a puzzle why clinical development organisations struggle so often with the “end of process task” of distributing Safety Reports*....