- Overview
- Frequently Asked Questions
Overview
Frequently Asked Questions
Common questions about Astraea and how it supports clinical development workflows.
Does Astraea replace biostatisticians or statistical programmers?
No. Astraea is designed to support these roles rather than replace them. The platform provides an AI‑assisted execution layer that automates parts of the biometrics workflow while keeping humans responsible for review and approval.
What stages of clinical development does Astraea support?
Astraea is designed to assist across the clinical trial lifecycle, from protocol design through regulatory submission preparation.
What standards does Astraea work with?
The platform supports workflows aligned with CDISC standards, including SDTM, ADaM, and Define‑XML.
What types of outputs can Astraea generate?
Astraea workflows can produce standards‑aligned deliverables such as SDTM datasets, ADaM datasets, Define‑XML files, annotated CRFs, and tables, listings, and figures used in clinical reporting.
How does Astraea maintain traceability?
Workflow steps are logged and reviewable. This allows teams to understand how outputs were produced and supports audit readiness during internal review or regulatory inspection.
Does Astraea support regulatory submission preparation?
Yes. The platform is designed to generate assets and reports aligned with regulatory submission conventions, including validation outputs and reviewer documentation.