SOURCE: Xtalks

Xtalks Webinars

May 29, 2015 10:29 ET

Risk Based Monitoring for Central Nervous System (CNS) Clinical Trials, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - May 29, 2015) - Join featured speakers Michael Phillips, Director of Product Innovation at ICON plc, and Gerard Conway, Director of Data Analytics at PerkinElmer to learn how risk based monitoring can be used to leverage common clinical data sources, advanced statistical methodologies and cutting-edge visualizations for central nervous system clinical trials. The live broadcast will take place on Thursday, June 11, 2015 at 11am EDT / 4pm BST (UK GMT +1).

Risk based monitoring is now recognized as a method to optimize clinical trial monitoring by the Food and Drug Administration, European Medicines Agency and Pharmaceuticals and Medical Devices Agency. In this webinar, learn how you can shift traditional frequency-based clinical monitoring for central nervous system clinical trials from frequency-based based to proactive and comprehensive risk based monitoring.

Central nervous system clinical trials have a relatively poor success rate, because of the difficultly to measure clinical endpoints. Clinical outcome assessments are often selected as primary outcome measures in CNS clinical trials. However, a small number of errors in these somewhat subjective instruments can profoundly affect study results.

As such, a standard analytics template for the central risk-based monitoring of CNS clinical trials has been built using TIBCO Spotfire. Using three key risk indicator (KRI) themes, a standardized clinical data model, a scales rule "engine" and interactive visualizations, a flexible analytics template has been built with the capability of deploying any CNS indication for any set of scales with study-specific KRIs. The scales rule engine is a self-service analytics tool, accommodating complex scale summation rules and study-specific KRI requirements without any need for additional programming or template.

Key benefits:

  • Attain actionable insights to clinical business users, throughout the organization by providing unmatched speed and flexibility to address clinical monitoring.
  • Uncover trends and patterns that represent risk or opportunities through intuitive visualizations, analytic dashboards and applications.
  • Connect to clinical data sources to include disparate clinical, operational and safety data in the risk monitoring program.
  • Enable self-service discovery to drastically reduce reliance on IT and eliminate delay related to data preparation, report building and spreadsheet version control.

To learn more about this event visit: Risk Based Monitoring for Central Nervous System (CNS) Clinical Trials

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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