FDA Guidance on Risk-based Monitoring while Improving Data Quality

The recent FDA Guidance stresses that Risk-Based Monitoring (RBM) is part of a high-quality study, and that upfront input into the study design is an optimal approach to achieving high quality results, which may increase both patient safety and overall data quality. Critical components for successful delivery include a well-designed protocol and the ability to leverage technology to monitor site and data quality.

Dan White, VP Global Operations and Quintiles RBM expert, has been managing studies using risk-based monitoring approaches for more than a decade. In this webinar, he will share his view of the most recent FDA guidance which:

• Highlights the importance of protocol design as part of an RBM approach
• Defines critical data and tasks ideal for remote activities
• Explains how RBM approaches can ensure subject protection and overall study quality
• Requires optimal data quality processes
• Indicates that ‘more intensive monitoring’ does not translate to on-site monitoring
• Strengthens FDA support of RBM.

Mr. White will be joined by Dan Ballard, Sr Director, Data Quality for Quintiles, to explain the impact of the FDA Guidance on clinical development, how Data-driven Trial Execution can enhance patient safety and data integrity, and, by using technology with enhanced processes as part of an RBM approach, data quality can be improved.

Speakers

Dan White, Vice President, Global Operations, Quintiles

Dan White leads Quintiles’ centralized monitoring and endpoint adjudication groups. In this position, Dan leads over 26 centralized monitoring locations around the world, including centers in Latin America, Eastern/Western Europe, Australia, South Africa, India, and the US (largest center). Dan has been with Quintiles over 13 years and is Quintiles subject matter expert on risk-based monitoring, working with sponsors on the implementation of risk-based monitoring across the Quintiles organization.

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Dan Ballard, Senior Director, Data Quality, Quintiles

Dan Ballard leads Quintiles’ Enterprise Data Quality Center and Clinical Operational Analytics group, where he manages Quintiles’ enterprise data quality governance, data standardization, and internal data champion group. He also leads a series of complex analytical projects that augment Data-driven Trial Execution (DTE), productivity and quality efforts. Dan has over 16 years experience in the Pharmaceutical industry and was most recently a board member of the Metrics Champion Consortium (MCC).

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