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Visualize rapid, validated insights through real-world data.
AETION® SUBSTANTIATE
Transform real-world data to decision-grade evidence
Aetion Substantiate is an advanced analytics application designed to meet regulatory standards and enable decision-grade studies with precision and transparency.
Setting the RWE standard
Substantiate is a scientifically validated application for implementing high-impact studies that generate decision-grade evidence to inform regulatory, payer, and clinical decisions on safety, effectiveness, and value.
Substantiate provides structured, bias-aware workflows for cohort building, study execution, and transparent reporting, with reusable components and standardized logic to boost efficiency and scale evidence generation.
Built for researchers who need efficiency and transparency
For safety teams
Implement descriptive analysis and follow up on any signals with comparative analyses. Maintain key outcome definitions across projects for efficiency.
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For RWE teams
Generate interpretable evidence for stakeholders; maximize efficiency by using team-approved measures and cohorts.
For HEOR teams and payers
Demonstrate and clearly communicate the comparative value of treatments in key populations.
No-code dynamic workflows
Unlike time-consuming manual coding options like SAS or R, Substantiate guides you step-by-step through study implementation.
Implementation guardrails
Workflow settings automatically adjust based on study type. Analytic options pre-populate with best practices.
Plain text audit trails of implementation
Easily share downloadable audit logs, including relevant methodology, with internal decision-makers or external reviewers.
Aetion Measure LibraryEliminate ambiguity with 11,600+ pre-built definitions for diagnoses, procedures, and therapies, curated by Aetion scientists and aligned to publication-grade standards. 
CohortsGuided workflows help filter groups of patients with the flexibility to suit any cohort design. Easily re-use cohorts across other analyses or among teams using the Cohort Library.
Analysis plansCustomize templated statistical analyses to suit your study. Implement explorations, queries, and complex comparative designs transparently with validated bias-reduction methods.
Custom analysesAccess Analytic Cohort Files in a secure coding environment like RStudio, combining programming flexibility with Substantiate’s auditability and reproducibility.
Implement studies efficiently and transparently
Built on Aetion Evidence Platform®, Substantiate is widely used by global biopharma organizations, regulators, payers, and health technology assessment bodies looking to execute studies from concept through to regulatory submission.
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“This tool allows us to save a considerable amount of time in the design, programming and presentation of results.” Substantiate user, Top 40 Biopharma Partner |
