Aetion

Products / Substantiate

Critical decisions, made clear

To tap into disparate data and causal conclusions, Aetion® Substantiate is your software superpower.

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Setting the RWE standard

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

Powered by the 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.

Related Articles

The application and user interface previously known as Aetion Evidence Platform® (AEP) is now known as Aetion® Substantiate.

AEP continues to serve as the robust analytics engine now powering multiple user applications.

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