Duncan and two new members of the TRI team (Rachel Oakley, VP RBQM and Maureen Fosdick, VP Sales) attended the MCC Clinical Trial Risk and Performance Management Summit in Philadelphia on the 4th and 5th September. Duncan was part of the panel session on Risk-Based Site Monitoring Emerging Practices, and facilitated one of the breakout discussions on ‘Keeping the Risk Assessment Up To Date’. Below are his notes and observations on the event.
“It was a well organised, interesting and valuable event. I was struck by the fact that there was no challenge to the value or importance of risk-based quality management (RBQM) from any of the participants. Their main focus was on implementation challenges and approaches.
It was no surprise that the biggest barrier to implementation is change management. Many operational managers are unfortunately still having to convince their leadership teams to act, and act now. We see this time and again in our work with sponsors and CROs.
I ran a round table meeting on the maintenance of risk assessments during study conduct. The big take-away from the discussion was that there are still a huge range of approaches and maturity levels. Many companies are using Excel based tools and are struggling with the constraints and inefficiency that these tools force upon their users.
There are still big challenges for sponsor and CRO partnerships in how they engage around RBQM and where responsibilities lay. The commercial model is going to have to change if we are going to accept that monitoring activity is going to be data driven and not set in stone at the point of contract award.
The event finished with a hands on workshop event which gave participants a feel for what central monitoring feels like and drove a series of data driven decisions and interactions with sites and vendor partners. This was a really valuable exercise and something we need to do more of to help RBQM adoption and execution.
The TRI team had many great conversations with the attendees and I look forward to all the follow up meetings we have booked.
Well done to Linda Sullivan, Keith Doricott and everyone else involved for making it a great event.”