We offer Sponsors and CROs a better way of identifying, visualizing, managing, and documenting trial risks that could compromise patient safety and delay the approval of Investigational Products.
Underpinned by Central Statistical Monitoring, a technique that's currently being investigated by the Food and Drug Administration (FDA) for selecting sites for inspection, our cloud-based products are deployed to support traditional onsite monitoring, medical review and quality to drive a Risk-Based Approach to Study Execution (RBx) and ultimately, to achieve ICH E6 (R2) compliance.
Underpinned by Central Statistical Monitoring, a technique that's currently being investigated by the Food and Drug Administration (FDA) for selecting sites for inspection, our cloud-based products are deployed to support traditional onsite monitoring, medical review and quality to drive a Risk-Based Approach to Study Execution (RBx) and ultimately, to achieve ICH E6 (R2) compliance.
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Here at CluePoints, we do things differently. We understand that a fun environment can be highly motivating and productive. When smart people work on problems, and they enjoy coming to work each day, they accomplish great things together. Is it time we got YOU onboard? We're proud to employ the best in the business so if you think you're a good fit get in touch!
Key Risk Indicators
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A Unique Combination of Statistical Analysis and Subjective Thresholds to Identify Study Risks. CluePoints' KRI Dashboard harnesses the power of statistical algorithms to provide a convenient way to monitor how sites are performing versus the metrics that are important to the trial. Sites are ranked and prioritized by those with most performance issues, thus illuminating the sites that are 'at risk'.
Quality Tolerance Limits
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CluePoints' Quality Tolerance Limits module offers Sponsors and CROs a convenient way to rapidly identify systematic issues, document the quality management approach and any deviations from the pre-defined Quality Tolerance Limits, all of which takes the study a step closer to being ICH E6 (R2) compliant.
Business Intelligence
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Access a library of shared or personal reports that provide insights into all clinical and operational data. Benefit from a suite of available visualizations styles that best present the data of interest. Export output to support identification of new risks or communicate risk narrative with other stakeholders.
Risk Assessment & Mitigation
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Engage all stakeholders to collaboratively assess each trial for risk, with version control and audit trail. Begin your ICH E6 (R2) compliance by performing a comprehensive study risk assessment that informs you as to the vulnerable areas of your trial, while providing the ability to define risk controls and monitoring capabilities so that you're able to spot risk evolving during study execution.
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