Advancing Regulatory Science

Aetion is an industry-leading RWE standard setter with deep regulatory relationships.

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Work with regulators & HTAs

Decision-makers require decision-grade evidence. Aetion partners with regulatory bodies and HTAs to advance the use of RWE globally.


These partners include:

Advocacy Groups, Professional Societies, & Convenors

Aetion’s solutions and expers help drive RWE standard advancement through collaborations with key industry groups, including:


In order to generate decision-grade evidence from real-world data, you need to ensure that data and study design are fit-for-purpose as well as establish trust through transparency and auditability.

“Aetion is best-in-class in an emerging field that has many imposters. It’s very difficult to tell the difference between crappy and good, and it’s crucial that we do.”

— Dr. Rob Califf
FDA Commissioner

Setting the Standard for RWE

Aetion is an industry leader because we pioneer best-in-class scientific approaches. Our seminal peer-reviewed publications push the thinking on what constitutes regulatory-grade evidence and enable broad applicability and acceptance.

Setting the Standard for RWE



A structured framework for creating a fit-for-purpose study design that can generate valid and transparent RWE



A structured framework for determining which datasets are fit-for-purpose to answer a given research question



SPIFD2 harmonizes SPACE and SPIFD templates, calls for articulation of the hypothetical target trial and sources of bias that may arise, incorporates STaRT-RWE reference


Aetion is a proud leader and partner of multiple demonstration projects pushing scientific thinking on RWE.