Wednesday, April 9, 2014

CluePoints' Unique Risk-Based Monitoring Technique

Central Statistical Monitoring (CSM) is a key element of the FDA and EMA Regulatory Guidance documents on the subject of Risk-Based Monitoring. The principle of CSM, as defined in the various regulatory guidance documents, is that statistical techniques can be used by Sponsors and CROs to determine the quality and integrity of study data with a view to making better informed decisions regarding monitoring strategy and to ultimately de-risk the study itself.

Last week, CluePoints joined us in Las Vegas at Partnerships in Clinical Trials to share more.  In the following video, like their presentation, they showcase the power of this approach by exploring how they interrogate the entire clinical data set independently and objectively using a comprehensive suite of statistical algorithms to determine exactly where data anomalies are present in centers, regions, countries and subjects. Unlike other Risk-Based Monitoring techniques which depend on a subjective decision regarding the data to analyse and the most appropriate threshold of risk, this approach leaves no stone unturned in assessing data quality, allowing sponsors to target resource on all ‘at risk’ centers quickly and easily. The following video describes how to harness these powerful statistical techniques to improve data quality and reduce cost:

 
CluePoints - Risk Based Monitoring from CluePoints on Vimeo.




No comments: