CDISC 360i Roadmap to Enable Standards Driven Automation from Study Design Through Results and the Intersection with Clinical Data Management

Earlier this year, CDISC launched 360i, a multi-year initiative to break down the existing standards adding the required semantic information to enable standards driven automation across the study information lifecycle from the protocol design through study results. A very important step in that information lifecycle is the definition, collection, and exchange of the critical data required to make decisions. As the industry sees the growth of different data sources such as DHTs, medical devices, and RWD, data management becomes even more important to ensure we can robustly support the data management components. By taking the first step in digitalizing the protocol content for use downstream, we can realize the transformative change required to enable the end to end automation we want to achieve.

This panel discussion will introduce the audience to the CDISC 360i initiative, provide the link between this initiative and the work within Clinical Data Management, and offer the opportunity to have an open discussion with a group of industry experts to explore where we go next.