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