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.

“The secret of change is to focus all of your energy, not on fighting the old, but on building the new.” These words are from a character named Socrates in a book published in the 1980s by Dan Millman (and not from the renowned Greek philosopher!). This seamless and constructive transition from old to new...

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*....

The expectations of regulatory inspections are rising – requirements are getting tighter and sponsors are expected to make better use of their systems and data. In our Inspection Perspective: Tales From a Recent FDA Inspection session from the Take...

In the ClinOps Perspective: So, Oversight When You Can’t Visit Sites, eh? session from the Take a New Perspective on Compliance series, our attendees learned how to still fulfill common GCP obligations during a global pandemic. We listened as...

The expectations of regulatory inspections are rising – requirements are getting tighter and sponsors are expected to make better use of their systems and data. In our Inspection Perspective: Tales From a Recent FDA Inspection session from the Take...

The expectations of regulatory inspections are rising – requirements are getting tighter and sponsors are expected to make better use of their systems and data. In our Inspection Perspective: Tales From a Recent FDA Inspection session from the Take...

From our webinar: Uncover Study Compliance Blind Spots with the myClin Compliance Score Compliance Blind Spots Our objective today is to understand the full compliance disposition of your study, to show everybody has the latest information and to track...