Today’s reality demands bold (and discerning) pursuit of real-world evidence (RWE) capabilities. At Aetion, we’re setting the standard for deep work at scale.
Substantiate is an advanced analytics application that enables users to assess the safety, effectiveness, and value of medical technologies. Widely used by global biopharma organizations, regulators, payers, and health technology assessment bodies, Substantiate generates decision-grade studies without compromising transparency or reproducibility.
The clear route to reliable evidence
Built on Aetion Evidence Platform® (AEP), and backed by automatic audit trails, use Substantiate to:
Iterate to achieve balance within your comparative cohorts
Implement study designs with best-suited measures and outcome models
Build causal studies to generate evidence of safety or effectiveness
Development
External control arm feasibility
Real-time safety contextualization
Standard of care characterization
Pre-launch
External control arm implementation
Adverse event and background rate understanding
Comparative effectiveness or safety evidence for regulators
Launch
Clinical effectiveness evidence for HTA/payers
Signal refinement/evaluation
Post-launch
Post-launch safety study program execution
Pregnancy study execution
Comparative effectiveness and safety evidence for label expansion
Built for causal data science
With pre-built methodologies, error-mitigating guardrails, and push-button “show your work,” Substantiate is the answer to no guessing.
Measures
The building blocks for your study: Data-specific algorithms that connect clinical concepts to study implementation
Build customized measures, or pull from the Aetion Measure Library
At any time, view the plain-language version of a measure
Standards-based analyses
Study workflows based on best practices such as SPIFD and START-RWE
Multiple study design options to suit the demands of your research question and dataset
Guardrail workflows
Workflow settings that automatically adjust based on study type
Analytic options pre-populated with best-practices
Bias trap safeguards, e.g., by “gray-ing out” selection options
Reviewer-ready results and reports
Flexible reporting of all study-generated tables and plots
Exportable audit log including relevant methodology
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Aetion Evidence Platform®
Aetion Evidence Platform® (AEP) is the core technology platform harnessing potential patient impact in any real-world data source for real-world evidence and insight generation. The forward-thinking backend for all of your real-world data and analytics management needs.
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