WAYNE, PA — CluePoints made three clinical data review applications generally available ahead of the SCDM 2026 conference Sept. 14-17 in Raleigh, North Carolina, extending its software beyond risk-based quality management into query detection, safety review and medical coding as drug developers seek to automate labor-intensive trial workflows.
The products — Intelligent Query Detection, Medical & Safety Review and Intelligent Medical Coding — were developed with an unidentified top-10 pharmaceutical company and are already deployed across most of that partner’s ongoing clinical studies, according to CluePoints.
The expansion moves CluePoints further into the day-to-day management of clinical trial data, where sponsors must identify discrepancies, conduct medical and safety reviews and code medical terminology before study databases can be finalized.
Intelligent Query Detection, or IQD, allows data managers to define clinical or operational scenarios without writing code. The software continuously applies those rules to study data and returns records that meet criteria for additional review.
CluePoints said the approach is intended to replace broad manual reviews with targeted queries and allow study teams to modify detection logic without waiting for software changes.
Medical & Safety Review, or MSR, combines information from multiple sources into patient-level views and directs reviewers to changes in study data. Queries can be sent back to electronic data capture or data-management systems from the same environment.
The application also records review activity as it occurs, creating an audit trail. CluePoints said MSR is system-agnostic and can be deployed for new or ongoing studies.
Richard Young, CluePoints’ chief strategy officer, said the company is trying to reduce repetitive review while leaving clinical decisions with specialists.
“The science does the searching, the expert does the deciding,” Young said. “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.”
The third application, Intelligent Medical Coding, uses deep learning to suggest MedDRA and WHODrug codes and operates within Veeva Vault EDC.
CluePoints said the coding system can achieve up to 99% accuracy for MedDRA and reduce manual coding work by approximately 50%. Those performance figures are company-provided claims.
The application also uses an organization’s previously validated coding decisions, allowing prior coding practices to carry across studies, teams and subsequent versions of medical dictionaries.
CluePoints developed the applications with data-management, medical and coding teams at its pharmaceutical partner and said the software was tested and validated in production. The partner contributed to IQD’s user-defined scenarios and MSR’s change-based review model.
The launch builds on CluePoints’ existing risk-based quality management business, which applies statistical and analytical methods to clinical-trial oversight.
CluePoints will demonstrate the three applications at the Society for Clinical Data Management’s 2026 Annual Conference in Raleigh. The pharmaceutical development partner is also scheduled to participate in the launch program during the conference.
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