Clinical Visual Analytics for Review and Submission (CVARS)

Development of an open-source tool and package to enable generation of identified interactive plots for clinical review and direct inclusion in submissions to regulatory agencies. The initial scope is to develop a package to generate interactive forest and volcano plots for adverse events and FDA Medical Queries (FMQs) analysis outputs for inclusion in submissions to the FDA. This work is a collaboration among the American Statistical Association (ASA), PHUSE and the FDA.