Quick Buzz Feed
CluePoints launches AI tools for clinical data review with capabilities targeting 99% accuracy in medical coding and cutting manual effort by half.
CluePoints has introduced three advanced AI-based capabilities designed to transform clinical data review processes, which traditionally rely on manual, time-consuming methods. These tools were developed and rigorously tested in collaboration with a leading pharmaceutical company. The core aim is to enhance accuracy and significantly reduce the manual workload associated with clinical trials. One key feature, Intelligent Medical Coding (IMC), is projected to achieve up to 99% accuracy in MedDRA suggestions and halve the manual coding effort. This is particularly impactful given that institutional coding knowledge often needs to be re-established with each dictionary update or team change, making these AI tools a crucial advancement for efficiency and consistency in the pharmaceutical industry.
The newly launched suite includes three distinct, yet complementary, AI-powered tools: Intelligent Query Detection (IQD), Medical and Safety Review (MSR), and Intelligent Medical Coding (IMC). IQD empowers data managers to define clinical or operational questions using plain language, eliminating the need for complex coding or vendor change requests. The system then continuously applies this logic, flagging only records that require human intervention. MSR replaces traditional, static spreadsheet-based reconciliation of medical and safety data with a dynamic, patient-centric workflow. This innovation allows for queries to be posted directly back to the Electronic Data Capture (EDC) system, thereby streamlining the process and eliminating significant delays often caused by handoffs between medical, safety, and data management teams. Both IQD's user-defined scenario architecture and MSR's change-based review model were shaped by extensive co-innovation with a top pharma partner and are already in use across a majority of their ongoing studies, including large-scale trials.
The timing of this launch coincides with significant regulatory updates in the clinical trial landscape. The ICH E6(R3) Good Clinical Practice guideline was finalized in January 2025, becoming effective in July 2025 by the EMA and published in September 2025 by the FDA. This updated guidance formally integrates risk-based quality management (RBQM) principles, an area where CluePoints has already been a pioneer with its existing RBQM platform. By extending its statistical and scientific foundation into query management, medical review, and coding, CluePoints' new AI tools provide an integrated data oversight workflow. This unified framework is designed to be fully compliant with the new guidelines, eliminating the need for teams to reconcile disparate system outputs before taking action, thus ensuring a more coherent and compliant operational approach.
A notable aspect of the MSR capability is its rapid deployment, taking only days to implement. Crucially, it is designed to function across ongoing studies, not just new ones, overcoming a common hurdle where organizations typically wait for a new trial to start before adopting new technologies. This immediate applicability allows for widespread impact and efficiency gains without operational pauses. The efficacy and speed of these tools will be further demonstrated at the SCDM 2026 Annual Conference in Raleigh, where the unnamed co-innovation partner's data management leadership will join CluePoints to present production results. This public showcase will offer tangible evidence of the tools' performance and impact, moving beyond initial proofs of concept to real-world, large-scale implementation successes within a major pharmaceutical company.