CluePoints® offers cloud-based software to improve data quality, increase operational efficiency and reduce regulatory submission risk. The solution is used by all types of Sponsors, CROs and Clinical Technology Organizations to drive Risk-Based Monitoring (RBM) and Data Quality Oversight. It works by harnessing a unique, patent-protected engine comprising a comprehensive suite of statistical algorithms to ensure that no stone is left unturned in surfacing potential issues in both clinical and operational data.
No other RBM or Data Analytics product offers this entirely independent, unsupervised and technology agnostic approach which the regulators and industry as a whole now refer to as Central Statistical Monitoring (CSM). CluePoints offers unique advantages:
- A proven statistical engine that rigorously interrogates both operational and clinical data
- An integrated platform that combines Key Risk Indicators (KRIs), Overall Data Quality Oversight, TransCelerate’s RACT (Risk Assessment Categorization Tool) and Issue Tracking Management
- Seamless integrations with EDC, CTMS, IRT systems and other data repositories
- An ethos of continual improvement ensuring that industry needs are being served now but with a clear roadmap of how this approach will be shaping clinical trial management in future