Astraea / FAQ
Clear answers before you begin.
Practical answers about Astraea’s clinical biometrics software, deployment, review responsibilities, and evaluation.
What is Astraea?
Astraea is clinical biometrics software for connecting study data, standards, analysis, and review. It supports workflows from SDTM mapping and ADaM derivations through tables, listings, figures, and submission preparation, with qualified reviewers retaining approval responsibility.
Is Astraea a CRO or a CTMS?
Astraea provides software that a sponsor’s team can operate in its own environment. It does not replace a clinical trial management system or assume the responsibilities of an outsourced CRO. Teams can use it alongside existing services and study systems.
Where does Astraea run?
Astraea is installed in the client environment. Network boundaries, access permissions, retention, and operational controls are agreed during technical evaluation. An air-gapped deployment is an architecture choice to evaluate with the client’s security team.
Does Astraea replace statisticians and programmers?
No. Qualified statisticians and programmers review study definitions, statistical methods, mappings, quality checks, and deliverables. Astraea supports execution and keeps evidence available for those decisions.
How does Astraea support SDTM and ADaM?
Astraea proposes SDTM mappings from collected data and connects ADaM derivations to SDTM inputs and analysis definitions. Reviewers check study-specific interpretation, terminology, derivation logic, and validation findings before approving outputs.
Can reviewers inspect how an output was produced?
Astraea connects outputs with the underlying code, data, and analysis context. Reviewers can investigate the path from source records to a result rather than treating a generated table or figure as a standalone answer.
Is clinical data used to train shared models?
Clinical data remains in the client environment and is not used to train shared models. Any external service or model configuration must be evaluated against the agreed deployment and data-handling controls.
Is Astraea SOC 2 certified?
SOC 2 work is in progress. Astraea does not present that work as a completed audit or certification. Discuss deployment-specific security requirements and available evidence with the team.
How should a team evaluate Astraea?
Start with a representative workflow and agreed acceptance criteria: source data, study definitions, expected outputs, review responsibilities, and quality checks. Evaluate the proposed mappings, derivations, and supporting evidence before expanding scope.