Overview
March 2026 – IMPALA’s newest publication has been released in Therapeutic Innovation & Regulatory Science. In this work, IMPALA member representatives introduce the open-source R package CTAS (Clinical Trial Anomaly Spotter), which had been developed to facilitate risk-based statistical monitoring of clinical trial data. The package analyzes subject-level time series data to detect inconsistencies at both site and subject levels, enabling timely intervention during clinical trials.
The publication demonstrates through simulations that CTAS can reliably detect site anomalies of varying types and degrees. The tool represents a valuable addition to risk-based quality management strategies in clinical trial oversight. This release aligns with IMPALA’s commitment to developing and publishing open-source analytics tools that enhance the quality of clinical trials.
We encourage you to read the publication, and learn more about CTAS!
Details
March 2026 – Therapeutic Innovation & Regulatory Science
Authors: Pekka Tiikkainen (Bayer), Björn Koneswarakantha (Roche) and Frederik Collin (Boehringer Ingelheim) On behalf of the IMPALA (Inter coMPany quALity Analytics) Consortium