Standardized real-world rare-disease data for FDA compliance

Certara is a biosimulation software company (Simcyp, Phoenix) whose PK/PD and QSP models predict drug behavior in the body; the FDA itself licenses Certara's software to review sponsor submissions.

This sits in the Build stage of the AI use-case lifecycle: Named examples from the foundation-model labs and platforms pharma teams use to actually construct, train and generate the model or application.