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TORONTO, ON--(Marketwired - August 13, 2015) - 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. The live broadcast takes place on Thursday, September 10, 2015 at 11am EDT / 4pm BST (UK/GMT+1).
Since the publication of the FDA's "Draft Guidance for Industry: Oversight of Clinical Investigations -- A Risk-Based Approach to Monitoring" and the EMA's "Reflection Paper on Risk Based Quality Management in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.
To learn more about this event visit: Risk Based Monitoring Adoption Simplified
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.NEXT ARTICLE