MSR

CluePoints' Medical & Safety Review (MSR) is a clinical trial management solution designed to centralize and standardize clinical data review processes. By replacing error-prone manual workflows with AI-powered, automated tools, MSR provides pre-made and fully customizable review dashboards that streamline query management from study setup through completion. The solution is purpose-built for Clinical Data Managers, Medical Reviewers, and Safety Reviewers working within pharmaceutical companies, Contract Research Organizations (CROs), medical device organizations, and academic institutions.

Accurate data is the backbone of successful clinical trials. Every piece of patient data — from electronic health records (EHRs) to lab results — holds critical value for decision-making, influencing both trial outcomes and patient safety. MSR addresses the limitations of traditional manual review methods by keeping data fresh, consolidated, and error-free, reducing inefficiencies and helping to protect patients throughout the trial lifecycle.

Key Features of the MSR Tool

• Automated Record Change Monitoring: Identifies changes in reviewed records, ensuring efficient evaluation of data points and maintaining high record quality throughout the trial.
• Full History of Records: Tracks all 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: Delivers regular data updates to address emerging trends and potential safety issues, supporting proactive, informed decision-making and enhanced organizational communication.
• Customizable Dashboards: Empowers users to create their own custom dashboards or select from a library of existing ones, simplifying clinical data exploration and visualization preparation.
• Automated Detection Rules: Processes and flags records of interest using defined filter criteria to enhance the efficiency of clinical data review.
• Centralized Query Integration: Enables teams to raise EDC queries and ensures all queries are logged, updated, documented, and resolved within a single platform.
• User-Friendly Review Workflow: Tracks individual record reviews with the ability to comment on records and assign them to other reviewers.
• Interactive Dashboards: Allows users to filter, sort, and drill down into research study data to expertly visualize and interact with information, delivering insights at a glance.

Core Capabilities and Solutions

• Streamlined Study Visualization: MSR provides a comprehensive visualization library with the ability to copy, reuse, and customize dashboards for specific study data requirements. This significantly reduces the time spent on clinical study preparation, enabling teams to quickly set up tailored visualizations and optimize internal alignment.
• Fast Outlier Identification: Predefined filters enable rapid and accurate record identification, ensuring potential issues are flagged early. 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 or clinical trial safety review process remains consistent regardless of the reviewer or the study being reviewed. By highlighting variable-level delta changes with calculations from the previous review, MSR simplifies tracking, minimizes variability, and helps teams maintain high-quality reviews.
• Seamless System Integration: MSR integrates research 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 throughout the trial.

Who MSR Is Designed For

• Contract Research Organizations (CROs)
• Pharmaceutical companies
• Medical device organizations
• Academic research communities

MSR is part of CluePoints' broader clinical trial optimization platform, which leverages advanced statistics, machine learning, and AI to deliver best-in-class Risk-Based Quality Management (RBQM) solutions. Together, MSR and RBQM provide a comprehensive approach to clinical trial oversight, helping sponsors and CROs identify outlying values, track changes, and improve workflow communication as they work to develop innovative therapies and improve patient outcomes worldwide.