Using Risk-Based Clinical Trials Monitoring to Improve Data Quality - Webinar CD/Transcript

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Using Risk-Based Clinical Trials Monitoring to Improve Data Quality

Do the numbers add up for using risk-based clinical trials monitoring?

RBM versus traditional studies survey results show:

  • 4x lower errorrate in critical data in a head to head comparison of RBM to traditional 100% SDV in 2015
  • 45% reduction in the number of missing pages in RBM studies vs. traditional studies in 2015
  • 47% higher Action Item closure on RBM vs. non-RBM in 2015
  • 5x as many RBM study sites enter data within 7 days vs. traditional study sites (46% vs 8%) in 2015
  • Up to 25% savings

Are you ready to transform your clinical development through advances in RBM?

Join Alan Frederickson and Crona O’Conallain — both of QuintilesIMS —  on Nov. 30 when they’ll share recent research showing how RBM can increase study quality and patient safety.

By attending this 90-minute sessiom you’ll find out how to design and implement a risk-based clinical trial monitoring program, starting with key concepts including:

  • The latest insights of how RBM is transforming clinical development
  • Understanding the challenges to overcome while implementing an RBM approach
  • The technology to helpto implement centralized monitoring
  • Why the distribution of data across your study sites might trigger an alarm
  • Key metrics that can point to poor performance and noncompliance

This session will give you a roadmap for establishing a risk-based monitoring plan that can1) prevent no data "surprises" in your monitoring that could be revealed during an inspection … 2) help you be fully compliant … and 3) satisfy the FDA.

In addition, you'll take away these invaluable specifics:

  • The latest technology and analytics advances for centralized monitoring, the core of risk-based monitoring
  • Data points to monitor
  • Essential critical risk factors your monitoring plan toconsider
  • Key components that should make up your monitoring plan — and what they each should contain
  • Must-have documentation requirements for every monitoring plan
  • Non-monitoring considerations: how to be sure your risk-based monitoring doesn’t undermine other elements of trial compliance
  • Medical Affairs Officers
  • Director of Clinical Operations
  • Regulatory Affairs Professionals
  • Director of Publications
  • Director of Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers

Meet Your Presenters

Alan Frederickson, Senior Director, Technology & Automation Solutions, Data Sciences, Safety & Regulatory, QuintilesIMS
As Sr. Director, Technology and Automation Solutions for Quintiles, Alan focuses on enhancing the quality and efficiency of technology solutions to support Risk-based Monitoring, Clinical Data Management, Biostatistics, Medical Writing, Regulatory and Pharmacovigilance, with workflow management and data accessibility, aggregation and analytics.

Crona O'Conallain, Senior Director Data Sciences, Safety and Reporting at QuintilesIMS
Crona O’Conallain holds a B.Sc. and Ph.D. in Biochemistry from University College Dublin (UCD). Crona has held numerous leadership positions with her 14 years in the QuintilesIMS Global Data Management organization, and is now on the QuintilesIMS’s leadership team for Risk Based Monitoring, leveraging her Data Management experience in supporting the development of a Centralized Data and Operational Surveillance (CDOS) organization that drives the RBM model.