CluePoints continues to transform clinical trial review and leverage its industry-leading software to enhance the interrogation, analysis and presentation of data with the launch of its latest application, Medical & Safety Review (MSR).
The tool simplifies and streamlines the medical analysis of study data through user-friendly dashboards, data manipulation and cleaning, query management and full transparency over the data history. This not only improves efficiency and communication in medical oversight, but also elevates patient safety, differentiating MSR as a smarter and unique solution.
Designed by, and for Medical and Safety Reviewers, MSR converts the manual analysis of patient outcomes, which can be prone to inefficiency and error, into an accurate, efficient process. MSR tackles time-consuming study preparation for specific visualizations by featuring a comprehensive standard visualization library as well as the ability to copy and reuse dashboards across different studies, enabling the identification of outlying values, change tracking, and improved communication for smarter clinical trials.
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Other benefits of MSR include:
- Enhanced medical review efficiency and reduced human errors via automated checks
- Reduced time spent by clinical and data management teams in reviewing data
- Improved collaboration with integrated review workflows across departments
- Ensured record quality and accountability with comprehensive change tracking
- Driving faster decision making with the proactive detection of trends and safety issues
- Ensuring regulatory compliance with rule-based detection and user assignments
Andy Cooper, Chief Executive Officer at CluePoints, commented, “We are thrilled to announce the launch of Medical & Safety Review to our growing product offerings. MSR is the latest application addition to the CluePoints platform, which includes products such as Risk-Based Quality Management (RBQM) and our Site Profile & Oversight Tool (SPOT). Together, they provide a comprehensive approach to clinical trial optimization, enhancing data integrity, ensuring regulatory compliance, and accelerating drug development. The creation of MSR ensures a more streamlined review process while prioritizing patient safety at every step and empowers medical teams to swiftly identify outliers, track data changes, and improve communication.”
CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. We are leveraging the potential of Artificial Intelligence using Advanced Statistics and Machine Learning to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.
SOURCE: PRNewswire