CluePoints Launches Three AI-Led Clinical Data Review Capabilities, Co-Innovated with a Top 10 Pharmaceutical Company
Intelligent Query Detection, Medical & Safety Review and Intelligent Medical Coding are now generally available, extending CluePoints' science-first approach from RBQM into clinical data review. The partner will join CluePoints live at SCDM 2026 to celebrate the launch.
WAYNE, Pa., Sept. 3, 2026 /PRNewswire/ -- CluePoints, the premier provider of Risk-Based Quality Management (RBQM) and clinical data quality oversight software, today announced the general availability of three clinical data review capabilities: Intelligent Query Detection (IQD), Medical & Safety Review (MSR) and Intelligent Medical Coding (IMC). All three were co-innovated in close collaboration with a top 10 pharmaceutical company, with the applications live in the vast majority of ongoing studies (including mega-studies) today. The partner will join CluePoints on stage at the SCDM 2026 Annual Conference (September 14–17, Raleigh, NC) to celebrate the launch.
CluePoints built its reputation on applying peer-reviewed science to clinical oversight, an approach now enacted in ICH E6(R3) and deployed by CluePoints across thousands of studies, globally, and the basis on which risk-based monitoring became an industry standard. IQD, MSR and IMC apply that same rigorous and adaptable scientific foundation to three of the most resource-intensive workflows in clinical development: query management, medical and safety review and medical coding. These are the workflows where fragmented tools, broad manual checks and disconnected review cycles most often delay decisions and put data integrity at risk.
Each capability was built strategically in close partnership with a top 10 pharmaceutical company, shaped, tested and validated in production alongside their data management, medical and coding teams, against real portfolio pressure, and is deployed across their studies today. The partner's teams contributed directly to the design of IQD's user-defined scenarios and to MSR's change-based review model, the two capabilities CluePoints expects to have the most immediate effect on how sponsors organize clinical data review.
"Clinical data management has been fragmented by design, separate systems, separate teams, separate workflows. That is precisely why problems are identified late, reviewed time and time again, and ultimately acted upon too slowly," said Richard Young, Chief Strategy Officer at CluePoints. "We are setting a simpler standard: Only meaningful data issues should be reviewed, and reviewed just once, by the right person, using the right data, at the right time. That is the shift from human in the loop to human in the lead. The science does the searching, the expert does the deciding. Clinical trials have never been short of data, they have been short of the confidence to act on it early enough to drive the right outcome. That is the challenge we intend to solve."
Three capabilities, one scientific foundation
Intelligent Query Detection (IQD) replaces broad manual listing review with targeted, evidence-backed query generation and puts hyper efficient execution in the hands of the study team. Through user-defined scenarios, a data manager can ask any clinical or operational question. No code, no change request, no waiting on a vendor release cycle. The system applies that logic continuously and returns only the records where the answer suggests something needs attention. This is the point at which a data manager's own study knowledge becomes a repeatable, automated check, and the point at which detection logic stops being a vendor's roadmap item and becomes a study team's capability. IQD will enable high-performing teams to transform data management into a continuous decision-making capability, identifying risks early, targeting effort where it matters most, aligning cross-functional action and embedding quality oversight into study governance. The result: high precision queries, raised earlier, resulting in reduced site burden, faster, higher-quality responses and an accelerated path from Last Patient Last Visit to database lock.
Medical & Safety Review (MSR) turns a mandatory ICH-GCP obligation still run in many organizations on spreadsheets, static listings and manual reconciliation, into a continuous, patient-centric decision workflow. MSR unifies data from disparate sources without burdensome, error-prone mapping, presents the consolidated clinical picture of a patient rather than a stack of listings, and guides reviewers through live study updates proactively, avoiding re-work. Reviewers move from a signal to a contextualized query inside the same validated environment, including posting back to EDC / data management systems, removing hand-offs between Medical, Safety and Data Management. Review activity is captured continuously, building audit-ready evidence as the work happens rather than reconstructing it retrospectively. MSR is system-agnostic and available for all studies (ongoing and new), with deployment measured in days rather than months.
Intelligent Medical Coding (IMC) is an agentic application rather than another coding interface. IMC applies advanced deep learning to generate MedDRA and WHODrug coding suggestions, delivering up to 99% accuracy for MedDRA and reducing manual coding effort by approximately 50%. It learns from an organization's own validated historical decisions, so institutional coding knowledge is retained across studies, teams and dictionary up-versions rather than resetting each time. IMC operates within Veeva Vault EDC.
SCDM 2026
CluePoints will host a formal launch activation at SCDM 2026, including expert-led live demonstrations of all three capabilities, a dedicated clinical data review experience in the exhibition hall, and an evening launch event co-hosted with the co-innovation partner's data management leadership, who will be present throughout the conference. CluePoints' product strategy and scientific teams will be available for in-depth discussion of implementation, ICH E6(R3) alignment and clinical data review program design.
About CluePoints
CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. We are leveraging the potential of Artificial Intelligence using Advanced Statistics and Machine Learning to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6(R3), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.
SOURCE CluePoints
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