CluePoints, which specializes in providing risk-based study execution (RBx) and data quality oversite software for trial clients, has agreed to provide risk-based quality management (RBQM solutions to EPS sponsors. The aim of the implementation is to help drive early risk detection, improve quality and increase patient safety, cost-effectively and resource-efficiently.
Best practices
According to CluePoints, clinical research and pharmaceutical professionals are increasingly interested in using RBQM to boost efficiently and quality. Furthermore, the technology is designed to enable sponsors and CROS to comply with regulatory mandates, such as European Medicines Agency (EMA) rules around good clinical practice.
Patrick Hughes, chief commercial officer for CluePoints, told Outsourcing-Pharma that RBQM enables study managers to improve quality of studies from start to finish.
“Risk management underpins the overall quality of the trial by identifying, controlling and communicating,” he said. “RBQM encompasses all elements of the study, from planning right through to execution.”
Hughes added the EMA’s ICH E6 (R2) spells out what the optimal RBQM system should include:
- Critical process and data identification
- Risk identification
- Risk evaluation
- Risk control
- Risk communication
- Risk review
- Risk reporting
Critical components
Hughes explained the CluePoints solution was designed to tackle each element within the guidance, empowering sponsors and CROs to address each key component.
“The CluePoints Risk Assessment solution allows users to quickly and easily collaborate to identify critical process and data and evaluate both the risks themselves and the controls required to mitigate the risks throughout the study,” he said. “This allows full documentation and audit trails and is designed to be revisited at regular intervals throughout the study.”
Additionally, Hughes explained, users can uncover inherent risks using different elements within the portfolio. This is made possible through CluePoints proprietary statistical algorithms.
The CluePoints approach incorporates Central Statistical Monitoring (CSM), an unsupervised, independent and objective analysis of clinical and operational data. Organizations in Europe and North American have been adopting the approach to identify risks early on, and EPS plans to adopt CSM with its clients (largely in Japan) and elsewhere.
Tools designed into the central monitoring platform include risk assessment, key risk indicators, data surveillance, patient profiles and more. Clients are able to choose modules that fit their particular needs to implement RBQM in their operations.
