This webinar will provide an overview of the Analysis Results Standard (v1.0) to support Public Review for this standard.
Analysis results play a crucial role in the drug development process, providing essential information for regulatory submission and decision-making. However, the current state of analysis results reporting is suboptimal with limited standardization and poor traceability. Currently, analysis results (e.g., tables, figures, and listings) are often presented in static, PDF-based reports that are difficult to navigate and vary between sponsors. Moreover, these reports are expensive to generate and offer limited reusability. The CDISC Analysis Results Standard (ARS) Model and accompanying User Guide have been developed to support automation, consistency, traceability, and reuse of results data.
- Bhavin Busa, Clymb Clinical
- Bess LeRoy, CDISC
- Richard Marshall, CDISC