Recorded as a live Webcast at SAS on November 16, 2007.
- See how using CDISC standards helped several organizations participating in one collaborative project share and analyze data.
- Learn how to use software to uncover and explore safety data patterns graphically and interactively.
- Learn techniques for launching direct queries against adverse event safety data.
Edward Helton, CDISC board chair-elect, uses data sources from two pivotal studies that used similar but not identical protocols, were performed under current GCP, and whose results were published in the Journal of Neurosurgery. Helton shows how the data and results of these studies serve as a model for applying software technology in the compliant evaluation and reporting of drug safety and pharmacovigilance, with subsequent inquiries into signal detection and interactions among drugs.
Geoffrey Mann, a member of the CDISC Analysis Dataset Model (ADaM) team, demonstrates how to use SAS’ JMP® software for exploratory data analysis of the study data and for direct queries against the adverse event safety data, respectively.
Using CDISC Models to Analyze Drug Safety Data
Free On-Demand Video Webcast
Presenters:
Edward Helton, PhD, SAS
Geoffrey Mann, PhD, SAS
View the Technical Requirements
About the Presenters
Edward D. Helton, PhD
Edward Helton is chief scientist in Regulatory and Biomedical Affairs at SAS. He works primarily in the development of software to enable FDA Part 11 compliance and serves as a SAS representative to the pharmaceutical and healthcare industries. Helton serves as chair-elect of the board of directors for the Clinical Data Interchange Standards Consortium (CDISC). He is co-chair of the Health Level Seven Regulated Clinical Research Information Management Technical Committee and Outreach Committee for Clinical Research.
Geoffrey Mann, PhD
Geoffrey Mann is a pharmaceutical systems developer at SAS whose emphaisis is in using Clinical Data Interchange Standards Consortium (CDISC) models for SAS drug development solutions. He is a member of the CDISC submission pilot and Analysis Dataset Model (ADaM) teams. Mann was a developer of JMP Genomics software from SAS and worked on the Biology Student Workbench, a project of the National Center for Supercomputing Applications. Mann holds a PhD in biochemistry from the University of North Carolina at Chapel Hill.
