Risk-based Approach to Monitoring: Deployment Insights and Lessons Learned

Bringing a therapy to market can cost billions. Now with support from the FDA and EMA, the industry is ready to realize the promise of risk-based monitoring. Quintiles has been using elements of RBM since 2001 as a smarter, more efficient approach to clinical trial execution that focuses on critical data. In this webinar, Quintiles will share recent research insights and real experiences using a modernized approach to risk-based monitoring.

By integrating best practices from RBM studies with new approaches and innovative technology, we will share common challenges, lessons learned, and how to best apply processes and technology to deliver the optimal outcome for a study. Specifically, we will explore how to:

• Apply risk analysis to each study to evaluate the scientific and operational risk of each protocol
• Identify the optimal monitoring approach for each study
• Integrate dynamic monitoring and data analysis for faster identification of patient and study issues
• Place resources for optimal execution
• Leverage on-demand insights to implement risk-based processes and workflows compatible with a global regulatory requirements

Speakers

Dan White, Vice President, Global Operations, Quintiles

Dan White is Vice President of Global Operations for Quintiles centralized monitoring group (PCC) as well as the endpoint adjudication group (CEVA). In this position, Dan leads over 26 PCC locations around the world including centers in Latin America, Eastern/Western Europe, Australia, South Africa, India, and the US (largest center). Dan is Quintiles subject matter expert on risk-based monitoring, working with sponsors on the implementation of risk-based monitoring across Quintiles organization. Dan has been with Quintiles over 13 years and is based in NC out of the RTP office.

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Amanda Sax, Senior Director, Integrated Processes and Technologies, Quintiles

Amanda leads the development of Quintiles’ approach to Risk-Based Monitoring, Data-driven Trial Execution, which optimizes the clinical execution strategy for each study to help customers manage risk and improve efficiency. In this role, she oversees the processes that direct Quintiles Infosario®, a technology solution that seamlessly integrates data and systems to provide transparency and collaboration and drives faster, better-informed decisions.

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