Products / Substantiate

Critical decisions, made clear

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

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: 


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

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.


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.

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.