Panel Discussion: Empowering Toxicologists with Access to Near-Real Time Study Data through Interim Study Monitoring: The Sponsor’s Perspective
Tuesday, March 29 at 1:30 PM PST
Society of Toxicology Conference
San Diego, CA
Join us on Tuesday, March 29th for a panel discussion on Interim Study Monitoring with Epizyme and Olema Oncology.
Real-time study data from a CRO’s LIMS system can now be seamlessly integrated in near-real time, empowering Sponsors’ study monitors with a longitudinal study view at the individual and group levels. Ongoing data such as bodyweights, toxicokinetics, clinical pathology is visualized on study, and along with a Sponsors’ cytokine (e.g. ADA) data, bio-analysis PK assays, immuno-marker, and omics assays. Sponsors’ complete study data becomes indexed, searchable, analyzable in a single study or cross-study format, and ultimately exportable in SEND format – and this can be rapidly cross-checked against the Digital Study Report once published.
Interim Study Monitoring involves ingesting raw, unstructured electronic study data from disparate sources and at numerous timepoints throughout the study. Provisioning access to electronic study data helps move industry toward real-time analysis on ongoing studies, and away from the legacy practice of waiting for crucial data in the form of PDF Study Reports, which can be difficult to search or cross-reference for analysis when repositoried. As a result, critical decisions can be made sooner at the study and/or program levels.