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Company description

CluePoints is a Risk-Based Quality Management (RBQM) software company that harnesses advanced statistics, machine learning, and artificial intelligence to support clinical development. By transforming complex trial data into actionable human intelligence, CluePoints empowers pharmaceutical, biotech, and clinical research organizations to improve patient safety, ensure regulatory compliance — including with ICH E6(R2) and ICH E6(R3) — and accelerate the resolution of risks across clinical studies. The platform has been adopted by over 11,700 users, has de-risked more than 2,000 studies, and has detected upward of 220,000 potential issues.

CluePoints serves a broad range of clinical development stakeholders, providing AI-powered software solutions that address the full spectrum of trial quality management — from site monitoring and medical review to data cleaning and medical coding. The company is recognized as an innovator in the RBQM space and hosts the industry's leading annual RBQM event, RBQMLive, bringing together experts from organizations such as Tufts CSDD, Parexel, Deloitte, Syneos Health, and Veeva Systems.

Core Software Solutions

• Risk-Based Quality Management (RBQM): Illuminates real-time data anomalies using cutting-edge statistics and machine learning, offering users a superior method to manage trial risks and accelerate issue resolution.
• Medical & Safety Review (MSR): Facilitates the periodic review of study data through customizable, user-friendly dashboards, frequent data refreshes, and consolidated data synchronization.
• Site Profile & Oversight Tool (SPOT): Enables adaptive site monitoring for anomaly identification and actionable insights, improving study performance evaluation, site visitation planning, and risk assessment.
• Intelligent Medical Coding: Leverages deep learning technology to autonomously generate accurate coding suggestions, significantly reducing the burden of manual coding while improving code consistency.
• Intelligent Query Detection (IQD): Automates data discrepancy detection, eliminating manual review listings and leveraging advanced language models to enhance future data cleaning processes.

Key Capabilities and Technology

• Advanced statistical methods and machine learning algorithms applied to clinical trial data for real-time risk detection.
• Deep learning technology for autonomous medical coding suggestions, reducing manual effort and improving consistency.
• Advanced language models integrated into query detection workflows to support intelligent, automated data cleaning.
• Customizable and user-friendly dashboards enabling periodic and ongoing review of study data across sites and studies.
• Adaptive site monitoring capabilities that support risk-based visitation planning and performance evaluation.

Industry Presence and Resources

• Host of RBQMLive, the industry's leading annual RBQM virtual event, now in its 5th year, covering topics such as the ROI of RBQM, ICH E6(R3) in practice, and the future of AI in clinical trials.
• Maintains a dynamic Knowledge Center offering guides, webinars, and event resources, including The Ultimate Guide to Risk-Based Quality Management, which covers RBQM's evolution, implementation strategies, and best practices.
• Active presence at industry conferences and events, with an ongoing calendar of webinars and archived educational content.
• Collaborative partnerships with leading organizations across the clinical research ecosystem, including CROs, sponsors, and technology providers.

CluePoints continues to advance the science of clinical trial oversight, combining regulatory expertise with innovative AI-driven technology to help life sciences organizations worldwide deliver safer, more efficient clinical development programs.

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Software attributed to CluePoints

• IQDView
• MSRView
• SPOTView
• Intelligent Medical CodingView

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