Medical & Safety Review (MSR)
CluePoints’ MSR tool centralizes and standardizes data review processes, providing pre-made and customizable dashboards for efficient query management throughout a clinical trial. This is especially valuable for Clinical Data Managers and Medical and Safety Reviewers in pharmaceutical companies and CROs, who rely on manual processes to analyze patient data and safety outcomes from EHRs, lab results, and other sources during clinical trials—methods prone to error and inefficiency.
USERS
DE-RISKED
ISSUES DETECTED
MSR's Key Features
Boost review efficiency and streamline workflow communication with AI-powered solutions.
Change Monitoring
Identify changes in reviewed records, ensuring efficient evaluation of data points and high record quality.
History of Records
Track actions associated with a given record, including data point creation or updates, comments, queries, changes in assignee or status category, and more.
Frequent Data Refreshes
Address emerging trends and potential safety issues, ensuring proactive, informed decision-making and enhanced organizational communication.
Self-Service Dashboards
Empower users to create their own dashboards or choose from a library of existing ones, simplifying data exploration and visualization preparation.
Detection Rules
Process and flag records of interest using defined filter criteria to enhance the efficiency of clinical data review.
Query Integration
Raise EDC queries and ensure they’re all logged, updated, documented, and resolved within a single platform.
Review Workflow
Track individual record reviews with the ability to comment and assign records to other reviewers.
Interactive Dashboards
Filter, sort, and drill down into study data to expertly visualize and interact with information, delivering insights at a glance.
Streamlined Study Visualization
With a comprehensive visualization library and the ability to copy, reuse, and customize dashboards for specific study data requirements, MSR significantly reduces the time spent on study preparation. Teams can quickly set up tailored visualizations, optimizing preparation time, efficiency, and internal alignment.
Fast Outlier Identification
MSR features predefined filters for rapid and accurate record identification, ensuring potential issues are flagged early in the process. As query management progresses, MSR offers clear visibility of current statuses, tracks changes, provides comprehensive EDC query feedback, and streamlines user assignments.
Consistent Review Process
MSR ensures that the medical review experience is consistent regardless of who the reviewer is or what study they’re reviewing. By highlighting variable-level delta changes with calculations from the previous review, MSR simplifies tracking and minimizes variability, ensuring teams maintain high-quality reviews.
Seamless System Integration
MSR integrates data review and query management processes, reducing the frequency of system swaps. It automatically communicates queries to the source system via API, ensuring an efficient workflow. Paired with CluePoints’ broader offerings, MSR and RBQM provide a comprehensive approach to clinical trial optimization.
Medical & Saftey Review (MSR) Fact Sheet
MSR for Every Clinical Trial
CluePoints provides Sponsors and CROs with a smarter way to identify outlying values, track changes, and improve workflow communication. By leveraging the potential of AI using advanced statistics and ML, CluePoints is transforming a powerful, best-in-class platform of solutions into positive clinical development outcomes as our partners work to develop innovative therapies to improve the lives of people worldwide.
Contract Research Organizations (CROs)
Pharmaceuticals
Medical Devices
Academic Community
Risk-Based Quality Management (RBQM)
In addition to intelligent MSR, CluePoints’ RBQM solutions illuminate real-time anomalies through cutting-edge statistics and ML, offering users a superior method to manage trial risks and accelerate resolution.
