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Understanding Risk-based Monitoring: Is It Art, Science, or Both?
Tuesday, June 26, 2012
10:00 AM to 11:30 AM
Kathleen Findlen is an independent Clinical Research consultant with more than 20 years of experience in global drug development and clinical operations. She has extensive experience in outsourcing strategy and implementation, clinical project management, training, auditing and clinical compliance.
Jennifer brings over 10 years of experience with eClinical technologies. In her role as a Senior Director of Product Management, Jennifer is responsible for translating industry needs into deliverable solutions to help improve the overall clinical development process.
Ed Seguine is CEO of Clinical Ink, a provider of electronic source document technology. Previously he was CEO of Fast Track, General Manager of Medidata's Trial Planning products, and helped establish Eli Lilly's venture capital group. He has an MBA from Indiana University and a BS from BYU.
Andrew Roberts, Novartis Institutes for BioMedical Research, Switzerland
Waife & Associates, Inc. is a change management consultancy focusing on clinical research in the pharmaceutical industry. He spent much of his career in management positions within clinical operations harmonizing the scientific, procedural and technological components of clinical development.
FDA has recently issued two important and related draft guidance documents covering electronic source and risk-based monitoring. FDA now clearly expects sponsors to take better advantage of electronic data capture (EDC) technology by implementing a targeted, risk-based approach to monitoring data remotely. Targeted source document verification (SDV) can be a highly effective and low-cost method of implementing an innovative monitoring strategy where 100% monitoring of site data is costly and not needed. Yet, in light of these potential cost savings, targeted SDV is still more of a frequent discussion topic rather than a reality. This symposium will provide perspectives on how this guidance could change the day-to-day relationships of sites/sponsors/monitors.
Discuss FDA's Draft Guidance documents on electronic source and risk-based monitoring
Identify the issues decision makers must consider when implementing targeted source document verification (SDV), including the factors needed to calculate a detailed return on investment (ROI)
Recognize the operational impact of risk-based monitoring on sites/sponsors/monitors.
Audio Synchronized to PowerPoint