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June 2015

Risk-Based Monitoring Software for Operational Data Analysis

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15 June 2015

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, today introduced software to enable analyses of operational data using a risk-based monitoring approach at DIA 2015. The new software includes Key Risk Indicators (KRIs) that perfectly complement the statistical analysis of clinical data. This KRI+ approach allows sponsors and CROs to set their own subjective threshold levels, while also statistically examining data objectively to show how a single site’s KRIs can be judged against results across all other sites. CluePoints will demonstrate its latest software offering on booth #1511 at the DIA 2015 51st Annual Meeting in Washington, DC.

CluePoints’ award-winning SMART™ Engine lies at the heart of the solution and has been designed to offer independent and objective interrogation of clinical data, leaving no stone unturned in assessing data quality and integrity. The enhancement of the engine with the KRI+ approach provides users with the powers of statistical analysis alongside their own triggers for action across key operational variables. This means that more frequent operational analyses can be conducted, and, when coupled with exhaustive interrogation of all clinical data, the software ensures that sponsors and CROs are able to de-risk studies and improve data quality and integrity using an automated approach. Additionally, the new software will soon support an online, customizable version of the Transcelerate-recommended Risk-Assessment Categorization Tool (RACT), allowing the CluePoints monitoring platform to provide upfront study/site risk assessment.

“With our latest software release we wanted to enable our customers to incorporate objective statistical analysis, while also allowing users to assess key operational variables to provide the most meticulous interrogation of all clinical data”, comments Franҫois Torche, CEO CluePoints. “This is our latest advancement in helping our customers move towards 0% SDV and 100% data quality oversight, enabling clinical workflows to be streamlined and resources to be more effectively managed by focusing attention on the sites and data that really matter.”