Introducing The Industry's Most Powerful Solution to Risk-Based Study Execution (RBx)

CluePoints® software employs a Central Statistical Monitoring methodology, designed and perfected over the last 20 years, to drive its RBx solution. The unique statistical algorithms, at the heart of CluePoints,  independently and objectively determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Further, CluePoints has the operational experience and consulting expertise to support pre-study risk assessment, solution implementation and change management to ensure Sponsors and CROs can harness the power of the solution and comply with regulatory requirements. Aligned with guidance from the ICHFDA, PMDA and EMA, this unsupervised approach to data analytics supported by operational thought leadership is used by Sponsors, CROs and Clinical Technology Partners to support traditional on-site monitoring, data management and medical review processes. Following the advent of ICH E6 (R2), CluePoints is now the industry’s solution of choice to drive the paradigm shift towards an entirely different Risk-Based Approach to Study Execution (RBx) from pre-study risk assessment, through risk identification and control to final auditable documentation.

Illustrated representation of CluePoints Risk-Based Monitoring Software

Determine Study Risks

Identify study risks at the outset by using CluePoints’ Quality Risk Management system. The customizable Risk Assessment Categorization Tool (RACT) has been built in line with TransCelerate’s risk assessment methodology and fully complies with the obligations of ICH E6 (R2).

Establish Operational Workflows and Risk Controls

Mitigate risk throughout the study by using fit-for-purpose analytics to isolate potential issues and employing operational workflows to ensure that all stakeholders within the team understand their roles and responsibilities

Identify 'At Risk' Sites, Patients and Data

Immediately identify ‘at risk’ sites, patients and data and track corrective actions to successful conclusions, all within the platform

Track Risk Evolution Over Time

Track risk evolution over time and determine how corrective action has alleviated ongoing issues

Benefit from Our Team's Unrivalled Expertise

Although the solution 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 solution, 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.

Illustrated representation of CluePoints Risk-Based Monitoring Software

Determine Study Risks

Identify study risks at the outset by using CluePoints’ Quality Risk Management system. The customizable Risk Assessment Categorization Tool (RACT) has been built in line with TransCelerate’s risk assessment methodology and fully complies with the obligations of ICH E6 (R2).

Establish Operational Workflows and Risk Controls

Mitigate risk throughout the study by using fit-for-purpose analytics to isolate potential issues and employing operational workflows to ensure that all stakeholders within the team understand their roles and responsibilities

Identify 'At Risk' Sites, Patients and Data

Immediately identify ‘at risk’ sites, patients and data and track corrective actions to successful conclusions, all within the platform

Track Risk Evolution Over Time

Track risk evolution over time and determine how corrective action has alleviated ongoing issues

Benefit from Our Team's Unrivalled Expertise

Although the solution 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 solution, 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.