By Adam Wood, VP, Business Development at myClin
The standout content for me came on the afternoon of Day 1 in a series of quick fire presentations about Oversight Models. As I’m guilty of banging on about oversight for a number of years it was refreshing to listen to a different voice. What struck me in the ideas put forward by Denise Lee, Head of Clinical Operations @ Allergy Therapeutics and Annelies Legters, Senior Director Clinical Operations @ Kiadis Pharma was how ideas about Oversight are now becoming more mainstream. And not a moment too soon.
Let’s recap on the context for Oversight for a moment. Regulators are expecting to see increased evidence of Study Oversight by Sponsors and CROs. The 2018 roll out of ICH E6 R2 has only reinforced the expectation to see Oversight happening on a continuous and contemporaneous basis. But is this actually happening out in the field? How would you answer that question for your current study?
This pattern is further exemplified by the FDA Guidance on risk-based monitoring.
Here at myClin we are seeing a growing number of instances of sponsors hitting regulatory trouble due to lacking Oversight evidence. The cause is often ClinOps processes that typically position Oversight as an extra, parallel process – an additional burden when you’re already “totally maxed out” starting and and executing the study. Inevitably such extra processes can get neglected when time is short and despite best intentions, let’s be honest, we rarely go back and tidy up properly.
The good thing is the Denise and Annelies have useful suggestions to help.
The Allergy Therapeutics approach centres on a Sponsor Oversight Plan with these key features:
- Oversight is defined in advance
- Oversight is continuous
Annelies had another useful definition from a colleague:
- “Oversight is proof that you had real-time knowledge of study conduct versus an audit or review after the work is complete.” [Sharon Reinhard, Clinical Compliance Solutions]
- Part of the Kiadis approach has been to create a new internal Clinical Monitoring Liaison (CML) role – Kiadis staff who are experienced monitors. The Oversight need is satisfied when these CMLs go on co-monitoring visits with the CRO monitors – and of course document their activities promptly. Benefits include maintaining an ongoing relationship with their investigators and site coordinators, in parallel to the CRO and being aware of site issues/concerns.
Much of this chimes with the Oversight practices that myClin recommend to our clients. The myClin Clinical Oversight Platform becomes central to these activities – as the elegant tool that automatically builds your data-driven Oversight evidence pool. myClin is a comprehensive study management tool that brings together:
- Your Trial Master File (eTMF)
- and your Investigator Study Files electronically (eISF)
- your Learning Management (LMS)
- and Document Management for your hundreds if not thousands of study documents
- team communication and collaboration.
As well as this platform all myClin clients also get detailed advice as to what Oversight activities to commit to as appropriate to the specific needs of their study(ies). Just as the regulators are expecting.