A Unique Combination of Statistical Analysis and Subjective Thresholds to Identify Study Risks

ICH E6 (R2) dictates that “the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials” and the CluePoints KRI dashboard provides the perfect vehicle for compliance with this directive.

The CluePoints Key Risk Indicators (KRIs) are derived from both operational and clinical data and provide users with the power of an objective statistical analysis as well as subjective thresholds to trigger actions across key variables. Coupling KRIs with an exhaustive interrogation of clinical data (the Overall Data Quality Assessment from CluePoints) ensures that sponsors leave no stone unturned in de-risking studies and improve data quality and integrity.

Quickly and Easily Determine Sites ‘At Risk’

Identify ‘at Risk’ sites based on objective statistical results, unlike any other solution

Drill Down to Pinpoint the Reasons for Site Issues

Drill down into the patient data to interrogate the cause and effect, and select appropriate Patient Profiles to further interrogate the results

Document and Manage All Corrective Action

Flag all potential issues and ensure successful corrective action using the inherent Issue Tracking Management System ensuring compliance with ICH E6 (R2).

Ready, Set, Go!

Intuitive cloud-based solution that uses a familiar traffic light system to highlight anomalies

Benefit from Our Team's Unrivalled Expertise

Although the software gives you complete autonomy over the process and analysis with minimal training, CluePoints’ team of Thought Leaders, Data Analysts and Project Managers are on hand to guide and support you to ensure that you get the best out of the software, whether during a pilot phase or post implementation. Our consultants can also look at the overarching ‘people and process’ elements to drive the change management required to harness the power of the technology.

Quickly and Easily Determine Sites ‘At Risk’

Identify ‘at Risk’ sites based on objective statistical results, unlike any other solution

Drill Down to Pinpoint the Reasons for Site Issues

Drill down into the patient data to interrogate the cause and effect, and select appropriate Patient Profiles to further interrogate the results

Document and Manage All Corrective Action

Flag all potential issues and ensure successful corrective action using the inherent Issue Tracking Management System ensuring compliance with ICH E6 (R2).

Ready, Set, Go!

Intuitive cloud-based solution that uses a familiar traffic light system to highlight anomalies

Benefit from Our Team's Unrivalled Expertise

Although the software gives you complete autonomy over the process and analysis with minimal training, CluePoints’ team of Thought Leaders, Data Analysts and Project Managers are on hand to guide and support you to ensure that you get the best out of the software, whether during a pilot phase or post implementation. Our consultants can also look at the overarching ‘people and process’ elements to drive the change management required to harness the power of the technology.