Aetion® Substantiate

Transform real-world data to decision-grade evidence

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:


External control arm feasibility


Real-time safety contextualization


Standard of care characterization


External control arm implementation

Adverse event and background rate understanding

Comparative effectiveness or safety evidence for regulators


Clinical effectiveness evidence for HTA/payers

Signal refinement/evaluation


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

Implementation guardrails

Plain text audit trails of study implementation

Reusable study components across teams

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.


Standards-based analyses

Guardrail workflows

Reviewer-ready results and reports

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.