webinar

Remote Based Monitoring vs Risk Based Monitoring: Do You Know the REAL Difference?

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July 19, 2016

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Course Description

Clinical Development needs to transform the approach to clinical study conduct and monitoring practices in order to reduce the costs, time, and risk. Clinical trials account for much of the burgeoning drug development costs; therefore pharmaceutical firms are adopting risk-based monitoring (RBM) as a means to improve study quality and patient safety, while reducing risks and lowering costs.

As RBM gains in usage, it should not be confused with remote-based monitoring. Register for this educational webinar as industry experts explain and differentiate between the two; including the distinctions between project- level, site-level and patient-level risk indicators, and how to define each. Learn about the latest techniques for enabling remote monitoring in a regulatory environment. Hear examples of the type of study risk information that is utilized to prioritize remote and on-site monitoring of study patients. As a critical player in the monitoring process, understand how your site can be the most effective to ensure the quality and data integrity of the trial.

Learning Objectives

  1. Understand the difference between Remote-based Monitoring and Risk-based Monitoring
  2. Explore how to utilize proactive strategies based upon risk to prevent non-compliance
  3. Learn how to prioritize the remote and on-site monitoring visits for study patients
  4. Examine the project- level, site-level and patient-level risk indicators
  5. Recognize how the site focuses on quality and data integrity during the clinical trial in the risk-based monitoring model

Presenters

Jan Higgins, Director Knowledge Management, Quintiles

Carolina Carrasco, Senior Director, Site Management Delivery Unit Head, North Central Region, Quintiles