You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 2 Next »

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, lack of automation, and poor traceability. Currently, analysis results (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. To address these issues, the CDISC ARS team has been working on developing standards to support consistency, traceability, and reuse of results data. In this paper, we will outline the current state of analysis results reporting, the goals of the ARS team, and propose a new workflow that will revolutionize the way analysis results are generated.

  • No labels