Please join us for our March 31, 2020 webinar:
RBQM Insights – Understanding the Critical Importance of Early Risk Detection (With a Special Feature Addressing COVID-19)
The clinical research industry is in the midst of adopting Risk-Based Quality Management (RBQM) as a primary method for managing quality. RBQM encourages less reliance on traditional on-site monitoring including 100% source data verification/review (SDV/SDR), and greater reliance on centralized monitoring including the use of statistical methods to identify quality-related risks (e.g., unusual or unexpected data patterns). CluePoints and our clients and partners are accumulating an impressive body of evidence supporting the power of Centralized Statistical Monitoring (CSM) in effectively detecting emerging issues not only effectively but proactively as well. Early detection is critical to success, to ensure that corrective actions can be taken in time to prevent significant damange to patient safety, trial outcomes, and related costs. CluePoints in fact recently conducted “Data Quality Challenge” projects designed to demonstrate the ability of the CluePoints CSM solution to effectively and proactively identify sites with important known quality issues on previously completed clinical studies. The participating sponsor organizations provided completed clinical study databases to the CluePoints team with the following challenge:
- Can you identify the problem site(s) that the sponsor team discovered late in the execution phase of the study? The CluePoints team remained blinded to the scope and nature of the known issues, until after the initial analysis was executed on the completed study database and findings presented to the sponsor team
- How early in the conduct of the study would the CluePoints solution have identified the problem site(s)?
In this webinar, we will present and discuss the results of these data quality challenges, and also provide some key considerations and best practices for ensuring early detection of operational risks and issues:
- Added importance of centralized monitoring as a quality monitoring tool in light of the challenges being imposed on site activities and site monitoring by the coronavirus (COVID-19) pandemic.
- Designing Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) for earliest possible risk detection
HOW TO REGISTER FOR THE WEBINAR:
We are running two sessions to cater to different timezones:
Tuesday, March 31 at 10 AM BST/ 11 AM CEST
Tuesday, March 31 at 2 PM EDT/ 11 AM PDT
If either of the above sessions don’t work with your schedule, please register for one of the sessions and we will send the recording to you.