Their ISF is Your TMF

Their ISF is Your TMF

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.

Building the New myClin Brand

Building the New myClin Brand

“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...

Safety Report Distribution – Why Such a Hard Nut To Crack?

Safety Report Distribution – Why Such a Hard Nut To Crack?

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*....

Inspection Perspective: Tales From a Recent FDA Inspection

Inspection Perspective: Tales From a Recent FDA Inspection

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...

ClinOps Perspective: So, Oversight When You Can’t Visit Sites, eh?

ClinOps Perspective: So, Oversight When You Can’t Visit Sites, eh?

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...

Site Perspective – What Sites Really Think of Your Study Processes

Site Perspective – What Sites Really Think of Your Study Processes

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...

Hindered Site Visits? myClin Enables Reliable Communication and Remote SDV Support

Hindered Site Visits? myClin Enables Reliable Communication and Remote SDV Support

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...

Uncover Study Compliance Blind Spots with the myClin Compliance Score

Uncover Study Compliance Blind Spots with the myClin Compliance Score

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...

Scoring the Compliance of Your Study

Scoring the Compliance of Your Study

Clinical Operations staff typically have a number of pretty effective tools for understanding parts of the compliance picture for their study. These are implicit in the process and system choices that we make when executing a study – and we almost...

TMF Management & Good Trial Operations are Indivisible

TMF Management & Good Trial Operations are Indivisible

While good documentation practices have always been central to GCP and good clinical operations, the emergence of distinct eTMF systems and the related TMF teams, has meant that TMF management itself has to an extent been allowed to morph into something...