Clinical data review still runs largely on spreadsheets and manual listing checks, even as trial volumes grow, which is why it matters that CluePoints is releasing three AI-based capabilities built and stress-tested inside a top 10 pharmaceutical company’s live portfolio before going generally available. The two figures buried in the launch details tell the stakes: Intelligent Medical Coding (IMC) targets up to 99% accuracy on MedDRA suggestions and cuts manual coding effort by roughly half, gains that compound across every study that currently resets its institutional coding knowledge at each dictionary up-version or team turnover.
The three capabilities, Intelligent Query Detection (IQD), Medical and Safety Review (MSR), and IMC, each attack a different bottleneck. IQD lets a data manager define any clinical or operational question in plain terms, without code or a vendor change request, and the system applies that logic continuously, returning only records that need attention. MSR replaces static spreadsheet-driven medical and safety reconciliation with a change-based, patient-centric workflow that posts queries directly back to the EDC, removing the handoff between Medical, Safety, and Data Management that typically introduces the longest delays. The co-innovation partner’s teams shaped both IQD’s user-defined scenario architecture and MSR’s change-based review model, and the capabilities are already running across the vast majority of that partner’s ongoing studies, including mega-studies, at launch.
The regulatory timing is not incidental. ICH E6(R3) was finalized in January 2025, with the EMA making it effective July 23, 2025, and the FDA publishing it in September 2025. The guidance formally encodes risk-based quality management principles that CluePoints’ earlier RBQM platform helped establish in practice. Extending the same statistical and scientific foundation into query management, medical review, and coding now connects a sponsor’s data oversight workflow end-to-end under a single framework the guideline already recognizes, rather than requiring teams to reconcile outputs across disconnected systems before acting.
MSR deploys in days and works across ongoing studies, not just new ones, which removes the typical barrier of waiting for a clean trial start. The practical test of whether that speed holds at scale will be visible when the unnamed co-innovation partner’s data management leadership appears alongside CluePoints at the SCDM 2026 Annual Conference in Raleigh, September 14 through 17, presenting production results rather than a pre-launch proof of concept.
Source link: https://cluepoints.com/cluepoints-launches-iqd-msr-imc-clinical-data-review/
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
