CluePoints launches AI-driven tools to enhance clinical data review process

CluePoints, the leading provider of Risk-Based Quality Management (RBQM) and clinical data quality oversight software, has launched three new AI-led capabilities designed to enhance the clinical data review process. These innovations, co-created with a top 10 pharmaceutical company, will be showcased at the SCDM 2026 Annual Conference.

The new capabilities, Intelligent Query Detection (IQD), Medical & Safety Review (MSR), and Intelligent Medical Coding (IMC), are now available for general use in ongoing clinical studies, including large-scale trials. According to CluePoints, these tools are strategically built to address some of the most resource-intensive and time-consuming workflows in clinical development, such as query management, medical and safety review, and medical coding.

IQD, for instance, replaces traditional manual listing review with a more targeted and evidence-based approach. Using user-defined scenarios, a data manager can pose any clinical or operational question. The system then continuously applies logic to identify records that require attention, allowing for a more efficient and automated review process. This capability is expected to transform data management into a continuous decision-making process, identifying risks early and directing efforts where they are most needed.

MSR streamlines the medical and safety review process, turning a mandatory ICH-GCP obligation into a continuous, patient-centric workflow. By unifying data from various sources and guiding reviewers through live study updates, MSR reduces the need for manual reconciliation and minimizes re-work. This system-agnostic tool is available for all studies and can be deployed within days, making it a significant improvement over traditional spreadsheet-based methods.

IMC, on the other hand, leverages advanced deep learning to generate MedDRA and WHODrug coding suggestions, achieving up to 99% accuracy and reducing manual coding effort by about 50%. By learning from an organization's historical decisions, IMC ensures institutional coding knowledge is retained across studies, teams, and dictionary updates.

These new tools are a testament to CluePoints' commitment to applying peer-reviewed science to clinical oversight. Richard Young, CluePoints' Chief Strategy Officer, emphasized the importance of these innovations, stating, "Clinical data management has been fragmented, leading to delays and insufficient action. Our goal is to ensure that only meaningful data issues are reviewed and addressed promptly."

CluePoints will host a formal launch activation at SCDM 2026, featuring expert-led demonstrations of all three capabilities, a dedicated clinical data review experience in the exhibition hall, and an evening event co-hosted with the co-innovation partner's data management leadership. The company's product strategy and scientific teams will be available to discuss implementation details, alignment with ICH E6(R3) guidelines, and the design of clinical data review programs.

Young concluded, "We are setting a simpler standard: meaningful data issues should be reviewed just once, by the right person, at the right time. This shift from human in the loop to human in the lead will drive better outcomes and increased efficiency in clinical trials."