CluePoints

CluePoints® is a risk-based monitoring and central statistical monitoring solution that has been designed and refined over the past 20 years, and now ensures compliance with ICH E6 R2 obligations for sponsors and CROs. Its cloud-based software utilizes unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data. In accordance with guidance from ICH, FDA, and EMA, CluePoints® is used to support traditional on-site monitoring, medical review, quality risk management, and drive risk-based monitoring strategies.The vision of CluePoints is to provide enabling technology for ICH E6 R2 compliance, RBx risk-based study execution, and comprehensive data quality oversight in clinical trials. The company is committed to improving the quality of clinical research by employing intelligent statistical techniques to query operational and clinical data, supporting companies in taking corrective actions and submitting error-free reports. In the future, CluePoints will deploy new breakthrough technologies such as machine learning and predictive analytics to fully leverage the potential of this advanced data querying in clinical research.