Tagged: adam
2 results
Astraea
Astraea is a San Francisco startup building an AI-native operating system for clinical trial biometrics. Its agentic platform turns raw study data and a protocol into FDA-ready outputs - SDTM and ADaM datasets, TFLs, and submission packages - compressing work that normally takes months into days while keeping humans in the loop for review and regulatory sign-off. Founded in 2026 by Stanford's Joshua Wang and Sanmay Sarada, the company is part of Y Combinator's Spring 2026 (P26) batch.
PointCross Life Sciences
PointCross Life Sciences is a Foster City, California software and services company that turns the messy data of drug development into FDA-ready submissions. Through its XBIOM platform and eDataValidator, it standardizes nonclinical and clinical study data to CDISC SEND, SDTM and ADaM formats, runs a Hadoop-based data repository for sponsors, and supplies the U.S. FDA itself with the software reviewers use to read nonclinical submissions. The company quietly powers roughly a quarter of all FDA SEND submissions.