Risk Based Monitoring Adoption Simplified

Since the publication of the FDA’s “Draft Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and the EMA’s “Reflection Paper on Risk Based Quality Management in Clinical Trials” roughly two years ago, there have been many advertised products and support services related to risk based monitoring throughout the industry.

Since then, several alternative methodologies on how to implement risk based monitoring have been defined and discussed in whitepapers, blogs, and webinars. There is, however, one consistent aspect of risk based monitoring that is present in each product, service, or methodology – the need for a plan.

This webinar provides a framework to assist pharmaceutical, biotechnology and/or medical device companies in the development of a risk based monitoring plan that will define the various risks and steps needed to implement a risk-based monitoring strategy. The webinar includes discussions and planning strategies related to different approaches to source data verification; error detection and prediction, and the correction and prevention of those errors; and ‘real-time’ quality management.

Dr. Bill Gluck, DATATRAK Vice President Clinical Knowledge and Mr. Tim Lyons, DATATRAK Vice President Product Development and Operations provide insight on how to prepare for a practical implementation of Risk Based Monitoring. From the study guidelines to the trial team and the required reporting, you will gain valuable insight on the key activities required for the adoption of RBM.

Speakers

Dr. Bill Gluck, Vice President Clinical Knowledge, DATATRAK

Dr. Gluck has over 30 years of expertise in clinical research, with experience in sponsors, CROs, and with DATATRAK in a variety of roles. Dr. Gluck is also the Program Director for the Clinical Trials Research and Medical Product Safety/Pharmacoviligance programs at Durham Technical Community College. Dr. Gluck earned his Bachelor of Science Degree at the University of Scranton and Master and Ph.D. degrees from North Dakota State University.

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Tim Lyons, Vice President, Product Development and Operations, DATATRAK

Tim oversees the strategic direction of product development and the operations of the organization to deliver an exceptional user experience. Tim has held a variety of leadership positions at DATATRAK, including roles in Software Development, Product Management and Clinical Project Management services. Prior to joining DATATRAK, Tim worked with Pharm-Olam, a global Contract Research Organization (CRO), and IntraVantage Medical Devices. Tim earned a Bachelor of Arts Degree from the University of Minnesota.

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Rob Nichols, Chief Commercial Officer, Algorics

Rob Nichols is the Chief Commercial Officer at Algorics whose acuity solution is used by the global life sciences industry to transform the management of risk across the lifespan of clinical trials. He has held senior global corporate development roles at DATATRAK, Oracle, Phase Forward and Quintiles. Rob also currently chairs the European Association for Clinical Data Management eClinical Committee. He holds an MSc in Statistics and previously worked as a medical statistician at Imperial College and the London School of Hygiene and Tropical Medicine in London, England.

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