Monitoring Clinical Trials with a SAS Risk-Based Approach

With global regulatory encouragement, the life sciences industry is gaining momentum to embrace a risk-based approach to the monitoring of clinical trials. Typical to pharmaceutical organizations, there is wide variation regarding the level and speed of adoption, methodologies used, and technology employed to enable the process. The industry has a rich history of leveraging SAS ® to ensure safety and efficacy of clinical trial data used for regulatory submissions, and SAS is well suited to extend its analytical approach to the operations side of clinical trials as well. This paper addresses the challenges related to aggregating critical data sources from both biometric and operational systems in order to assess study risk related to patient safety, data quality and the overall integrity and performance of the clinical trial. Analytical methods will be shared for identifying risk indicators through the application of business rules, visualization techniques, and advanced analytical models.