Business Details
14 Years
experience
AI-Powered Clinical Trial Optimization Solutions
CluePoints is a pioneering provider of AI-powered solutions for clinical trial optimization, leveraging advanced statistics and machine learning to enhance data quality and risk management. Founded in 2012, our team of RBQM innovators has consistently delivered cutting-edge tools like the SMART Engine, transforming clinical research through intelligent data analysis. With expertise in risk-based quality management, medical coding, and query detection, we empower pharmaceutical companies, CROs, and academic institutions to streamline workflows, ensure regulatory compliance, and improve patient outcomes globally.Our commitment to innovation is reflected in our evolutionary timeline, which includes milestones such as FDA collaborations and the implementation of deep learning technologies. By combining technical excellence with a client-centric approach, we provide actionable insights that de-risk clinical studies and accelerate the development of life-saving therapies.
Services
Risk-Based Quality Management
Medical Coding
Query Detection
Data Review Tools
Clinical Trial Analytics
Details
- Year established: 2012
Highlights and features
- We offer 12+ years of pioneering experience in AI-driven clinical trial solutions since 2012
- Our patented SMART Engine powers advanced anomaly detection in clinical data
- We implement FDA-collaborated methodologies for data-driven site monitoring
- Our team combines deep clinical expertise with cutting-edge machine learning capabilities
- We provide end-to-end solutions covering all phases of clinical trial management
Services
Risk-Based Quality Management
Our RBQM solutions use machine learning to identify real-time data anomalies in clinical trials. This approach enables proactive risk mitigation through statistical analysis and pattern recognition, helping pharmaceutical companies maintain data integrity. The system provides actionable insights for site monitoring and regulatory compliance, reducing trial risks while accelerating resolution times across all clinical study phases.
Intelligent Medical Coding
This AI-powered solution automates medical coding through deep learning technology. It generates accurate coding suggestions while improving consistency across clinical documentation. By reducing manual coding efforts, the system enhances efficiency in trial data management while maintaining compliance with industry standards for medical terminology and classification systems used in clinical research.
Medical & Safety Review
MSR centralizes clinical data review processes with customizable dashboards for efficient query management. The tool standardizes safety reviews through automated record monitoring and frequent data refreshes. Designed for clinical data managers and safety reviewers, it streamlines workflow communication while ensuring compliance with regulatory requirements for pharmacovigilance and adverse event reporting.
Intelligent Query Detection
IQD automates data discrepancy detection using advanced language models to identify inconsistencies in clinical records. The system eliminates manual review processes while improving data cleaning efficiency. By leveraging natural language processing, it enhances pattern recognition capabilities for clinical data validation, reducing time spent on manual query generation and resolution.
Site Profile & Oversight Tool
SPOT enables adaptive site monitoring through anomaly identification and performance evaluation. The tool optimizes site visitation planning while providing risk assessment metrics for clinical trial locations. By analyzing site-specific data patterns, it helps identify high-risk locations requiring additional oversight, improving overall trial quality and regulatory preparedness.
People
Ken Getz
Founder & Chief Scientific Officer
Clinical research expert with 20+ years of experience in risk-based monitoring and data quality. Led development of SMART Engine technology and FDA collaborations. Focuses on advancing RBQM methodologies through statistical innovation and machine learning applications in clinical trials.
Dr. Jonathan Seltman
Chief Technology Officer
Technology leader with expertise in machine learning and clinical data systems. Oversees development of AI-powered solutions including Intelligent Medical Coding and Query Detection. Previously held technical leadership roles in healthcare IT companies, focusing on data analytics and system integration for clinical research applications.
Lynn Lewis
Chief Commercial Officer
Commercial strategy leader with extensive experience in clinical research technology markets. Manages global business development and client relationships. Previously held executive roles at clinical software companies, driving market expansion and strategic partnerships with pharmaceutical organizations and CROs.
Questions
What clinical trial phases do your solutions support?
Our AI-powered tools support all clinical trial phases, from early-stage research to post-marketing studies, with configurable solutions for varying complexity levels.
How does your RBQM software improve trial efficiency?
Our RBQM platform uses machine learning to identify data anomalies in real-time, enabling proactive risk mitigation and reducing manual monitoring efforts by up to 40%.
Can your system integrate with existing clinical data platforms?
Yes, our solutions offer API-based integration with EDC systems and other clinical data sources, ensuring seamless workflow continuity and centralized data management.
What regulatory standards do your tools comply with?
Our platform aligns with ICH E6(R3) guidelines, FDA requirements, and GCP standards, supporting audit-ready documentation and inspection preparedness.
How do you handle data security and privacy?
We implement enterprise-grade security measures including encryption, access controls, and regular compliance audits to protect sensitive clinical trial data.
What support options are available for new implementations?
We provide comprehensive onboarding, configuration assistance, and ongoing technical support with dedicated resources for system implementation and optimization.
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