Aetion® Substantiate is an advanced analytics application designed to transform real-world data into decision-grade evidence, meeting regulatory standards with precision and transparency. It enables researchers to implement high-impact studies that generate reliable evidence to inform regulatory, payer, and clinical decisions regarding the safety, effectiveness, and value of medical treatments. Key Features and Functionality: - No-Code Dynamic Workflows: Guides users step-by-step through study implementation, eliminating the need for manual coding. - Implementation Guardrails: Automatically adjusts workflow settings based on study type, with analytic options pre-populated with best practices. - Plain Text Audit Trails: Provides downloadable audit logs, including relevant methodologies, ensuring transparency and reproducibility. - Reusable Study Components: Allows saving and reusing measures and patient cohort definitions across studies and teams, enhancing efficiency. - Custom Analyses: Offers access to Analytic Cohort Files in secure coding environments like RStudio, combining programming flexibility with auditability. Primary Value and Problem Solved: Substantiate addresses the complexity of real-world evidence generation by providing structured, bias-aware workflows for cohort building, study execution, and transparent reporting. It ensures robust, reproducible, and transparent evidence, enabling researchers to efficiently implement studies from concept through regulatory submission. By offering a scientifically validated application, Substantiate empowers safety teams, real-world evidence teams, and health economics and outcomes research teams to generate interpretable evidence, maximize efficiency, and clearly communicate the comparative value of treatments in key populations.