Risk-based monitoring (RBM) continues to take center stage as one of the key areas of disruptive innovation in clinical development. Organizations are embarking on their RBM journey, leveraging the critical combination of cloud technologies, intelligent analytics and targeted monitoring tactics.  Harnessing the power of big data analytics in clinical trials is the latest advance in Risk-Based Monitoring.

This presentation will cover:

• How large datasets can be used for Risk-based Monitoring (RBM) to improve the data quality and the relevance of a development program beyond Key Risk Indicators (KRIs)
• How the use of centralized statistical analytics (CSA) enable life sciences organizations to quickly realize the quality, cost and timeline benefits of RBM using patient data in addition to operational data.

Speaker: Barbara Elashoff