SOURCE: Xtalks

Xtalks Webinars

September 22, 2014 07:05 ET

Using a Quality Clinical Risk Management Process to Implement Centralized Monitoring Under a Risk-Based Monitoring Approach: Concepts and Case Study, Live Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - September 22, 2014) - Implementation of centralized monitoring is significantly more than simply shifting certain clinical monitoring activities that were once conducted on site. Join this interactive webinar to learn more on Wednesday, October 1, 2014 at 11am EDT (4pm BST/ UK GMT +1).

In today's monitoring environment which has been enabled by recent guidance and reflection papers by regulators on clinical risk-based approaches to monitoring clinical study quality, monitoring activities should now be designed to track two types of risks identified in the clinical risk assessment:

  • Fixed risks, which are controlled by specifications in functional plans such as the clinical monitoring plan and data management plan; and
  • Dynamic risks, which are controlled by tracking key risk indicators (KRIs) which are defined in the systematic clinical risk assessment to trigger corrective actions if the KRI values exceed predetermined thresholds.

Join speakers Michael Macri, Director of Strategic Services at inVentiv Health Clinical, and Jeffrey Fetterman, President of ParagonRx, an inVentiv Health company, for an informative session and case study that will include implementation with the appropriate processes, enabling technologies, and workflow management.

To learn more about this event visit: Using a Quality Clinical Risk Management Process to Implement Centralized Monitoring and Risk-Based Monitoring: Concepts and Case Study.

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.

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Contact Information

  • Contact:
    Michelle Tran
    Tel: +1 (416) 977-6555 ext 352
    Email: mtran(at)xtalks(dot)com