SOURCE: Xtalks

Xtalks Webinars

January 03, 2017 08:15 ET

Bridging the Clinical Data Structure Gap for Holistic RBM: How Fully Integrated Data Empowers Risk Management, New Webinar by Xtalks

TORONTO, ON--(Marketwired - January 03, 2017) - On Thursday, January 19, 2017, Xtalks will host a complimentary webinar featuring Andy Lawton, Advisor at Risk Based Approach Ltd., and Pankaj Manon, Chief Technology Officer at ThoughtSphere, as the presenters.

The introduction of the ICH E6 (R2) addendum means that taking a risk based approach (RBA) within a sponsor is no longer an option but a requirement.

In selecting a system to meet the RBM aspects of a clinical trial, there are four main areas that have to be addressed in the sponsors' system landscape:

  • Risk identification
  • Risk monitoring
  • Issue management
  • Data integration

This webinar will focus on data integration. At the earliest stage of the draft guidances from the FDA and EMA on RBM, they identified that the silo'd nature of the sponsor was often a key issue. A silo'd organisation structure, is all too often also represented in the data availability. The first requirement is to have access to all the necessary data and the second is to be able to integrate them.

So why is data integration so important? Data integration brings to life risks that are not apparent when you examine the data from one source alone, examples shown will include eCRF and audit trail, CTMS, Drug Safety database, etc. As we gain more knowledge about risk then using additional data sources becomes more common.

For more information or to register for this free webinar visit: Bridging the Clinical Data Structure Gap for Holistic RBM: How Fully Integrated Data Empowers Risk Management

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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