Astraea

Clinical development teams working on biotech and pharma trials must produce SDTM, ADaM, and TLF outputs while keeping protocols, statistical analysis plans (SAPs), and study evidence connected and traceable for regulators. Today this traceability and QC work is manual, slow, and prone to disconnecting documents from the evidence that supports them, creating what Astraea's own blog content calls an 'evidence continuity' bottleneck. The company states that potential trial errors and cost overruns result from these bottlenecks, citing figures like 1500 potential trial errors avoided and $10M in potential cost savings identified through its approach.

Astraea offers an AI platform that automates SDTM and ADaM dataset generation along with TLFs, claiming full automation in as little as 7 days. The platform lets study teams explore study data, compare treatment arms, connect protocols and SAPs to study evidence, and inspect the code and data behind every analytical output, positioning itself as 'governed AI for every critical clinical decision.' It is offered both as a software platform and as an AI-augmented FSP (functional service provider) model, with solutions tailored to biotech, enterprise pharma, standards automation, and end-to-end biometrics use cases.