JMP Clinical Outlook - From Medical Reviewers (Past) to Clinical Operations (Present) to Clinical Data Science and Global Safety (Future)
Geoffrey Mann USA SAS Institute Inc. JMP Division Product Manager
In this session, we will present the history of JMP Clinical enhancements. Focusing on safety from the perspective of medical monitors and medical reviewers, Amit and other publications that help standardize the visualization of safety in clinical trials focused on graphs. Table elements from ICHE3 and FDA Reviewer's Guidance combined with interactive graphs and tables allow many subgroups to be created when displaying adverse events, laboratory tests and medication status. TransCelerate BioPharma Inc. (TransCelerate) and our company, Richard Zink, have integrated statistical central monitoring methods, including risk-based monitoring, to determine site and patient integrity (data quality) during clinical trials. We provide helpful methods. These methods are continually being improved, and some examples are also presented. At the end of the presentation, we will also discuss how we support clinical data scientists who help prepare content for scientific journals and global oversight teams who produce regular safety update reports.
