AI-generated from publicly available materials.CluePoints has introduced three AI-driven tools aimed at enhancing clinical data review processes, developed in collaboration with a leading pharmaceutical company.
The clinical trial landscape is still heavily reliant on spreadsheets and manual checks, which can hinder efficiency as trial volumes increase. CluePoints' new offerings—Intelligent Medical Coding (IMC), Intelligent Query Detection (IQD), and Medical and Safety Review (MSR)—aim to address these inefficiencies. IMC, for instance, seeks to achieve up to 99% accuracy in medical coding while halving the manual effort required, a significant improvement that can streamline processes across multiple studies.
IQD enables data managers to pose clinical or operational questions in straightforward language, eliminating the need for coding or vendor requests. This tool continuously applies defined logic, filtering out records that require further attention. Meanwhile, MSR transforms the traditional, static reconciliation process into a dynamic, patient-focused workflow, facilitating direct queries back to the Electronic Data Capture (EDC) system. This innovation minimizes delays typically caused by handoffs between different teams involved in medical, safety, and data management.
The launch of these tools aligns with upcoming regulatory changes, particularly the ICH E6(R3) guidelines set to take effect in mid-2025. By integrating risk-based quality management principles into query management and medical review, CluePoints positions itself to enhance data oversight processes within a unified framework. The effectiveness of these tools will be further evaluated when CluePoints presents real-world results at the upcoming SCDM 2026 Annual Conference.