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 (e.g., tables, figures, and listings) are often presented in static, PDF-based reports that are difficult to navigate and vary between among sponsors. Moreover, these reports are expensive to generate and offer limited reusability. To address these issues, the The CDISC Analysis Results Standard (ARS) team has been working on developing standards to support Model and accompanying user guide have been developed to support automation, consistency, traceability, and reuse of results data.
| Pagenav | First | true
|---|