Risk-Based Monitoring and Statisticians: An Evolving Role in Methods, Collaboration, Education, and Implementation

• Activity Number: 217
• Type: Topic Contributed
• Date/Time: Monday, August 4, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Rakhi Kilaru*+
• Companies: PPD

Abstract

Building quality and risk management approaches into the scientific design and operational conduct of clinical trials can mitigate risks and facilitate detection of quality compromising issues and prevention. TransCelerate BioPharma Inc., a non-profit entity with members from pharmaceutical and biotechnology companies continues to develop and build on a methodology that shifts monitoring processes to comprehensive risk-driven monitoring. In light of the most recent recommendations and methodology, the role of a statistician is evolving as an integral component to risk assessment, mitigation and monitoring tasks. A higher, different level of engagement and collaboration is urgently required of a statistician within the cross functional clinical setting in developing the integrated quality and risk management plan (IQRMP), in educating and collaborating with data scientists, clinical scientists and operational staff for successful roll-out of a risk based monitoring plan.