Getting FDA readiness right is crucial; it saves not only time but also the sunk costs of repeated revisions.

Astraea is an AI-native platform designed to automate the biostatistics processes of clinical trials. By inputting raw data, trial protocols, and metadata, it automatically generates SDTM, ADaM datasets, TFLs, and FDA-ready outputs that comply with CDISC standards. Traditional processes typically take 9 months and involve a team of 5-10 people, whereas this platform can complete the task within days. Currently focused on oncology and rare diseases, it is led by co-founders Joshua Wang (CEO) and Sanmay Sarada (CTO), both with backgrounds from Stanford, and has received support from YC.