Thanks to ICH E6(R2), the guideline for Good Clinical Practice, and other regulatory guidance, sponsors and CROs are motivated to apply risk-based monitoring (RBM) strategies to their clinical trials. The fact that the non-profit, TransCelerate, recently updated its Key Risk Indicators (KRI) library is an important indicator that RBM approaches are gaining traction.
In most cases, however, RBM approaches fail to provide workflows that take into account how human beings like to get information. Dashboards alone don’t cut it.
Using examples from eCommerce and online stock trading platforms, this thought-provoking webinar will explain the value of event-driven information delivery and how it can be applied to the clinical trial industry. By focusing on “events of interest,” participants will gain the ability to proactively identify risk at the portfolio, study, region, investigator and site levels.
Through a real-world pharmaceutical success story, participants will learn how to implement an event-driven RBM system that can:
- Aggregate data from different systems automatically
- Generate performance alerts at predetermined thresholds
- Facilitate collaboration through a fully auditable task management system