Being Best in Class – Accelerating Clinical Trials by Leveraging Metadata to Reduce Database Build Time

Session chaired by Ralph Russo

Description:

This session will explore various methods of leveraging standards and metadata to facilitate several aspects of data management, including database setup, SDTM creation, and downstream analytics. Attendees will learn how graph-based metadata structures or “data shapes” hold tremendous potential to revolutionize the conduct of clinical trials and provide immense value to the data management discipline. We’ll see real-life examples of how the use of end-to-end standards combined with unique automations can reduce cycle time and improve quality in DM processes.

Learning objectives:

• Understand how graph technology works, how data managers can incorporate information in these graphs into their daily work
• Learn how metadata can be used to build various components of clinical trial databases and submission modules
• Understand where metadata exists at our companies, how it can be combined with automation tools to improve quality and speed of deliverables
• Reinforce the role end-to-end data standards play in creating efficiencies from collection through submission