{simaerep} was originally developed to detect sites that are under-reporting Adverse Events (AE) in clinical trials using a nonparametric bootstrap algorithm. With the release of the most current version v0.5.0 {simaerep} can also be used to detect over-reporting. With this [...]
IMPALA's newest publication has been released in the April 2024 version of Therapeutic Innovation & Regulatory Science. In this paper, IMPALA member representatives validate the open-source R package {simaerep}, which was developed to facilitate rapid, comprehensive, and near-real-time detection of [...]
IMPALA Consortium is pleased to announce the release of its newest open-source R Package, the Clinical Trial Anomaly Spotter (CTAS.) CTAS is a powerful tool for Central Statistical Monitoring that identifies outliers and anomalies efficiently and accurately in clinical trial [...]
On November 9, 2023, IMPALA hosted a webinar on Embedding an Open Source Package into Analytics-Based Audits. During this presentation, Bjoern Koneswarakantha and Lisa Bennett of Roche discussed IMPALA’s Clinical Safety Reporting R package. This included testing, methodology, cross-validation between [...]
The write-up on the recent RQA Workshop on Data Analytics is now available. The workshop took place at the RQA Conference in Brighton in November 2022, and was facilitated by Jennifer Emerson (Boehringer Ingelheim), Joanne North (BMS), Paula Walker (Roche), [...]
