Aetion

Aetion® Substantiate

Transform real-world data to decision-grade evidence

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The route to reliable evidence

Aetion Substantiate is a scientifically validated application enabling researchers to navigate the complexity of RWE, harnessing diverse data sources for causal analysis.

Implement high-impact studies and generate evidence at scale for critical decisions on safety, effectiveness, and value in the real world. Substantiate ensures robust, reproducible, and transparent real-world evidence.

Setting the RWE Standard

Built on Aetion Evidence Platform® (AEP), 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.
Substantiate offers an advanced analytics alternative to traditional manual coding approaches and allows users to:

  • Implement study designs
  • Build causal studies to generate evidence of safety or effectiveness
  • Iterate to achieve balance within your comparative cohorts

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

 

Comparative effectiveness and safety evidence for label expansion

Execute high-impact studies efficiently, transparently, and with the flexibility you need.

No-code dynamic workflows

  • Unlike time-consuming manual coding options like SAS or R, Substantiate guides you step-by-step through study implementation.
  • Dynamic workflows based on best practices such as SPIFD and START-RWE change depending on the type of study or cohort being implemented.

Implementation guardrails

  • Workflow settings automatically adjust based on study type.
  • Analytic options pre-populate with best practices.
  • “Gray-ed out” selection options prevent users from measuring an outcome with an incompatible statistical model.

Plain text audit trails of study implementation

  • Executed analyses and cohorts always have full transparency.
  • Easily share downloadable audit logs, including relevant methodology, with internal decision-makers or external reviewers.

Reusable study components across teams

  • Save and reuse measures and patient cohort definitions for future studies.

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.

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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