Closely aligned with guidance from the FDA, EMA and ICH E6 R2, CluePoints® is used by sponsors and CROs as the engine to drive risk-based monitoring and study execution (what we are now calling RBx) and to provide broader risk mitigation and patient safety through overall Data Quality Oversight. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous patient data and site discrepancies allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.
Since the early 2000s, a dedicated team of statistical experts has been developing, validating and enhancing a powerful engine known as SMART™, a patent-protected software engine based on the industry-recognised concept of Central Statistical Monitoring (CSM). The solution allows users to assess the quality and integrity of clinical trial data in an independent and objective manner. Further our development team has added new product enhancements such as modules for Patient Profiles and Site Inspection Readiness and underlying technology to harness Machine Learning and Predictive Analytics. The product will continue to evolve to improve cost and resource efficiencies in clinical trials and ensure compliance with the regulatory requirements.