Challenges and Opportunities in Risk-Based Monitoring

This webinar will examine highlights of the draft guidance issued in late 2011 by the FDA entitled: “A Risk-based Approach to Monitoring” and will provide examples of potential cost savings and increased efficiencies gained by implementing a risk-based monitoring approach.

The presenters will discuss the concept of “risk” in terms of “lower-case risk” (the analysis and identifying of the data elements that are critical to the reliability of study findings) as well as “capital letter RISK” (that which a study sponsor might perceive they are taking on by adoption of a targeted approach to monitoring).

The webinar will also cover methods to adopt the draft guidance’s recommended changes in risk-based monitoring, including a review of statistical mechanisms to select forms for Source Document Verification (SDV), as well as tools that enable centralized monitoring and reductions in site visits and associated monitoring costs.

Key takeaways:

• How EDC can implement a selective approach to SDV, without risk of bias
• How to adopt a novel approach to central SDV
• What tools are available for data-driven monitoring
• Considerations for the development of a risk-based approach to monitoring

Speakers

Keith Howells, SVP Development, OmniComm Systems, Inc

Keith Howells is an executive with 20 years’ experience in the application of Information Technology to the drug development process. As Senior Vice President of Development at OmniComm, he is responsible for product innovation for the TrialMaster and eClinical suites. Previously, as Senior VP of Development for Medidata Solutions, he helped to catapult Medidata Rave from relative obscurity to being one of the most widely adopted EDC systems in the industry. Prior to that, he played a major role in establishing Oracle’s Pharmaceutical application business, initially as director of consulting for Oracle Clinical and then as VP of Development.

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Becky (Causey) Carpenter, VP of Operations, ResearchPoint Global

Becky (Causey) Carpenter has been in the CRO industry for 22 years. As the VP of Operations at ResearchPoint Global, she is responsible for the Clinical, Project Management, Data Management and Statistical service groups. Previously, she was the VP of Operations at INC Research where she provided oversight for Project Management and Clinical Operations as well as specialty groups, including study start-up, patient recruitment, and site contract management. Prior to that, Becky was the North American Executive Director of Project Management at PPD following positions as Director of therapeutic divisions including Immunology and Urology. Her primary therapeutic experience is in the areas of urology, immunology, women’s health, respiratory and endocrinology. Her study experience includes oversight of 100s of studies including more than 20 global trials.

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