CluePoints Launches Powerful & Pragmatic Solution to Risk-Based Monitoring
A new Software for Risk-based Monitoring
As biopharmaceutical sponsors search for the optimal approach to targeted monitoring and reduced Source Data Verification (SDV), CluePoints introduces an Intelligent Statistical approach like no other!
A new software and service provider of Intelligent Statistical Monitoring solutions – CluePoints – has been launched today to address the increasing industry need for a pragmatic approach to enable the risk-based monitoring theory to become a reality.
CluePoints allows biopharmaceutical sponsors and CROs to identify signals in a clinical trial data set and make timely decisions about which sites to target for monitoring activities and Source Data Verification (SDV). As a result, corrective action can be taken early and sites reassessed periodically throughout the course of a study to ensure the quality and integrity of the data, enhance patient safety and, ultimately, reduce regulatory submission risk.
The launch is in response to recent industry guidance from the FDA and a reflection paper from the EMA encouraging sponsors to embrace an alternative to traditional on-site monitoring techniques and to explore reduced Source Data Verification (SDV) using a risk-based approach to monitoring.
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