SOURCE: Xtalks

Xtalks Webinars

December 09, 2015 09:08 ET

Risk-Based Monitoring and The IRB: Convergence and Opportunities, New Webinar Hosted by Xtalks

The Presentation, Part of Chesapeake IRB's 2015 Advance Thought in Clinical Research Series, Will Examine the Opportunities for Improvement Introduced by RBM Invite Evaluation of a New Pattern of Interaction Between Clinical Development Teams and ERBs, and Provide Recommendations to Industry, ERBs and Other Stakeholders

COLUMBIA, MD and TORONTO, ON--(Marketwired - December 09, 2015) - Join keynote speakers Andy Lawton, Global Head of Biometrics and Data Management at Boehringer Ingelheim Ltd., and Ellen Kelso, Executive Director of Strategic Development at Chesapeake IRB, for a live one-hour session on Thursday, December 17, 2015 at 10am EST (3pm GMT).

Current and emerging technologies allow the collection and analysis of larger data sets that can provide more valuable risk management insights than smaller data sets. The ability to monitor near real-time data and aggregate it with other data sources enables better risk governance and decision making which improves the safety and speed of clinical trials.

Effective risk governance comprises both risk assessment and risk management. Risk-Based Monitoring (RBM) is an example of real-time data collection and analytics supporting an important, structured approach to clinical trial risk management. Risk governance has long been within the purview of ERBs, whose primary review tasks include risk-benefit assessment and evaluation of risk management processes. RBM is a component of risk governance, and its structure is surprising similar to the systematic evaluations of ERBs.

Clinical operation teams and ERB oversight can benefit from this natural alignment to improve effectiveness of trial monitoring and oversight. Risk governance requires the collaboration and coordination of all concerned with the collection, analysis and communication of all relevant risk information, including the ERB.

To learn more or register for this event visit: Risk-Based Monitoring and The IRB: Convergence and Opportunities

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