Aetion Substantiate

Aetion® Substantiate is an advanced analytics application built to transform real-world data (RWD) into decision-grade evidence that meets regulatory standards. Designed for global biopharma organizations, regulators, payers, and health technology assessment bodies, Substantiate enables high-impact studies with precision, transparency, and scientific rigor — from initial concept through to regulatory submission.

Built on the Aetion Evidence Platform®, Substantiate provides structured, bias-aware workflows for cohort building, study execution, and transparent reporting. Its reusable components and standardized logic are purpose-built to boost efficiency and scale evidence generation across teams and projects.

Who Substantiate Is Built For

• Safety teams: Implement descriptive analyses and follow up on signals with comparative analyses, while maintaining consistent key outcome definitions across projects for greater efficiency.
• RWE teams: Generate interpretable evidence for stakeholders and maximize efficiency by leveraging team-approved measures and cohorts.
• HEOR teams and payers: Demonstrate and clearly communicate the comparative value of treatments in key patient populations.

Core Capabilities

• No-code dynamic workflows: Unlike time-consuming manual coding approaches such as SAS or R, Substantiate guides researchers step-by-step through study implementation without requiring programming expertise.
• Implementation guardrails: Workflow settings automatically adjust based on study type, and analytic options pre-populate with established best practices to reduce the risk of methodological errors.
• Plain text audit trails: Downloadable audit logs — including relevant methodology — can be easily shared with internal decision-makers or external reviewers, supporting full transparency.

Key Features

• Measures: Provide a shared source of truth for algorithms and variable definitions across studies and teams. Complex queries can be set up quickly and come with interpretable plain-text descriptions.
• Cohorts: Guided workflows help filter patient groups with the flexibility to suit any cohort design. Cohorts can be easily reused across analyses or shared among teams via the Cohort Library.
• Analysis plans: Templated statistical analyses can be customized to suit individual studies. Explorations, queries, and complex comparative designs are implemented transparently using validated bias-reduction methods.
• Custom analyses: Researchers can access Analytic Cohort Files in a secure coding environment such as RStudio, combining programming flexibility with Substantiate's built-in auditability and reproducibility.

Workflow and Study Execution

1. Define and standardize measures and variable definitions using a shared library accessible across teams.
2. Build and filter patient cohorts using guided, flexible workflows, and store them in the Cohort Library for reuse.
3. Customize and implement analysis plans using templated, validated statistical methods with transparent bias-reduction techniques.
4. Access analytic cohort files in a secure coding environment for tailored research needs.
5. Generate downloadable audit logs and plain-text reports suitable for internal stakeholders or external regulatory reviewers.

Substantiate is widely adopted by top biopharma partners and regulatory bodies worldwide, with users reporting significant time savings in study design, programming, and results presentation. As part of the broader Aetion Evidence Platform ecosystem — which also includes Discover, Activate, and Generate — Substantiate serves as the foundation for trusted, decision-grade real-world evidence generation at scale.