Current Edition

CluePoints and Widler & Schiemann Collaborate on Complete Risk-Management Solution for Clinical Trials in Line with New Industry Guidance

Partnership will combine CluePoints’ Risk-Based Monitoring Software with Widler & Schiemann’s Consultancy Services

2 November 2015

Cambridge, MA – CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials, today announced a strategic collaboration with clinical trials business solutions consultancy, Widler & Schiemann Ltd. The collaboration will bring together CluePoints’ award-winning RBM software with Widler & Schiemann’s risk-assessment consulting expertise, 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 expertise 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,” comments Dr. Peter Schiemann, Managing Partner and Co-founder of Widler & Schiemann. “We are delighted to be collaborating with CluePoints to provide customers with a true end-to-end solution that helps them in the complete risk assessment of their quality management in clinical trials. As well as helping customers harness the power of the CluePoints solution in the most effective way possible, we can ensure that they do so in line with the GCP ICH E6 guideline, including its new amendment, and the new clinical trial regulation that is due to come into effect soon.”


CluePoints’ CEO, Franҫois Torche, said: “We work with many customers who are looking for strategic advice on adapting their organization and updating their internal policies to meet the needs of new RBM strategies. By bringing in the consultancy expertise of Widler & Schiemann we can work together to support customers and ensure they have both our industry-leading software and the expertise and guidance necessary to successfully implement a comprehensive risk-management solution.”