Astraea / Clinical trial automation
What is clinical trial automation?
A practical definition of clinical trial automation and its role in clinical data standards, analysis, and review.
A practical definition
Clinical trial automation uses software to execute repeatable trial workflows while preserving the evidence and controls needed for human review. In clinical biometrics, that can include data checks, SDTM mapping, ADaM derivations, statistical programming, validation, and assembly of submission deliverables. It is a way to support execution, not to remove accountability.
Astraea’s place in the workflow
Astraea focuses on connected clinical data and biometrics workflows operated in the client environment. It supports the path from study definitions and source data through standardized datasets and statistical outputs, with inspectable code, data, and review context. It works alongside existing study systems and qualified teams.
An illustrative review path
Consider a planned age-by-treatment summary. The team first agrees the population and source age variable, reviews the SDTM mapping and ADaM derivation, checks missing-value and denominator rules, then inspects the program and resulting table. If a value looks unexpected, source-to-result lineage helps the reviewer return to the contributing records. This example illustrates a review process; it is not a customer outcome claim.
What automation should preserve
A useful workflow preserves the study question, source inputs, derivation logic, execution context, validation findings, and approval decisions. Reviewers should be able to explain why an output is suitable for its intended use. Standards and regulatory requirements remain specific to the study and submission context.