Contract Research & Services
Clinical Trials

CluePoints - Intelligent Statistical Monitoring Case Studies

CluePoints - Intelligent Statistical Monitoring

Confirmation of Fraud at a Center Where Patient Diaries Were Ultimately Found to Have Been Completed by Site Staff The subject of this case study is a phase III trial in vascular disease. Over 4,500 patients were randomized across 160 sites. The CRF included 480 variables for 32 domains. The CluePoints solution was deployed after the last patient last visit. The sponsor had a specific concern regarding a center suspected to have falsified patient questionnaires.
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Identification of Under - Reported Adverse Events In this case study, we consider a double blind randomized phase III study in infectious disease. More than 5000 patients were randomized across 150 sites from 18 countries. A total 400 variables were collected in the CRF. A run of CluePoints was performed at the beginning of the follow - up period to detect any atypical site behavior and associated patient data issues.
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