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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 Analysis Results Standard (ARS) team has developed a logical model to support consistency, traceability, and reuse of results data. This hands-on implementation training will provide an in-depth overview of the ARS model and practical examples illustrating the implementation of the model using common safety displays.
