By Gayle Hamilton, Director, Risk-Based Quality Management and Zabir Macci, Director, Digital Trial Management Suite
Clinical monitoring, in its simplest form should use critical thinking driven by both experience and technology. Techniques like Risk-Based Monitoring (RBM) have been proven to de-risk key aspects of a trial by leveraging technology and analytics together with experience. The approach applies a data-driven strategy (central access to data and monitoring) for decision making both through the course of the trial and when issues arise. Thereby improving quality and safety together with reduction of costs (CRA Visits, reduced SDV, effective SDR, operational efficiency).
RBM has been implemented for over 10 years now, and Risk-Based Quality Management (RBQM) is now seen as the industry standard. While RBQM employs many of the RBM processes and uses the same core technology capabilities, including the role of centralized and remote monitoring, or integrated monitoring, it also provides an extensive planning approach to identify and mitigate risk throughout the trial. Executing an effective quality management process addresses trial complexity, costs, and quality issues.
The Evolving Monitoring Landscape:
- RBM/RBQM becoming the standard strategy decreasing the need for days on site
- Data collection simplification due to increased source integrations and access
- Evolving regulations; ICH E8/R1, E6 R2/R3
- Continual advancement of technology such as eSource, eConsent, connected devices, etc. enabling automation and manual task reduction
- Trials requiring flexibility and robust processes for effective delivery