CluePoints, a Cambridge, Mass.-based software provider of risk-based monitoring (RBM) solutions for clinical trials, is collaborating with clinical trials business solutions consultancy Widler & Schiemann.

The collaboration will bring together CluePoints’ RBM software with Widler & Schiemann's risk-assessment consulting to deliver a comprehensive solution that covers all elements of risk and quality management. From software implementation through to operational considerations and meeting regulatory requirements, the partnership will support customers in integrating all-inclusive RBM strategies within their clinical trials.

Widler & Schiemann’s experts work with clients to identify how workflows, processes and systems need to be adapted to support more targeted approaches to monitoring in clinical trials. The company's services complement CluePoints’ Central Statistical Monitoring (CSM) software, which provides an agnostic approach to RBM by using statistical methodology to identify unexpected patterns in trial databases and focus monitoring efforts. To accompany the statistical analysis of data, the software also defines and deploys key risk and key performance indicators, allowing sponsors to set their own subjective thresholds. Combining the experience of the two companies now offers customers a complete risk-management solution with expert guidance on how to implement CluePoints' software, helping improve trial oversight while driving quality and patient protection.

“As RBM approaches become the standard for today’s clinical trials, it is vital that sponsors have the support they need both in terms of practical technology solutions and the knowledge to guide the implementation of these new methods of analysis within their organizations. In addition, the CluePoints solution allows sponsors to base their RBM decisions on facts and figures rather than opinions,” said Dr. Peter Schiemann, managing partner and co-founder of Widler & Schiemann.