Manual ADaM programming is a high-cost bottleneck, consuming weeks of statistical programmer time per study to map SDTM data, derive variables, and generate define.xml. This custom agentic workflow automates that logic, cutting dataset creation cycle time by 60-80%. The architecture deploys specialized agents to interpret protocol and statistical analysis plans, execute CDISC-compliant transformations, and embed validation checkpoints, directly reducing labor costs and improving data quality for integrated summaries.




