Mini-Workshop Session: “RBQM, Back to the Future”
Many companies still struggle with getting their RBQM process off the ground, frequently due to not knowing how to ‘sell’ RBQM to their management. One rather successful way is to run a retrospective analysis of a completed study that had issues associated with it.
At the 4th Annual WCG MCC Clinical Trial Risk & Performance Management Collaborative vSummit, our CEO, Artem Andrianov, and CSO, Johann Proeve, will lead a mini-workshop that will explore the options available to set up a retrospective analysis of a study based on a straightforward protocol, discuss how to determine the risks, the key risk indicators and how to set the thresholds.
Discussion Group Session: “How to Identify Critical Processes & Data”
ICH E6(R2) expects companies to implement RBQM based on critical processes and critical data in their studies. Sometimes, however, it is rather difficult to identify those critical processes and critical data since almost everything in a study seems to be critical (or at least should be).
At the 4th Annual WCG MCC Clinical Trial Risk & Performance Management Collaborative vSummit Artem and Johann will lead a discussion group on how to identify the critical processes and critical data to get this process started.