Standards and Submission Automation

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Overview

Clinical submissions require a large set of standardized data structures, documentation, and reports. Astraea automates much of this preparation by generating key assets used in regulatory submissions.

The platform focuses on producing outputs that are aligned with submission conventions and ready for regulatory review.

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Key Deliverables

Astraea workflows can generate several types of assets commonly required during submission preparation, including:

• SDTM datasets
• ADaM datasets
• Define‑XML documentation
• Annotated electronic case report forms (aCRF)
• Tables, listings, and figures (TLFs)

These assets are validated against submission conventions to help ensure consistency and regulatory readiness.

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Validation and Reporting

The platform integrates validation steps into the automation process. Generated assets can be checked using industry validation tools such as Pinnacle 21.

Reporting artifacts may include submission documentation such as:

• Pinnacle 21 validation reports
• Study Data Reviewer’s Guides (SDRG)
• Analysis Data Reviewer’s Guides (ADRG)

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From SAP to Submission Package

Astraea connects statistical analysis planning with reporting outputs. By linking workflows to the Statistical Analysis Plan, the platform helps generate TLFs and related submission artifacts within a structured pipeline.

The goal is to move from analysis planning to a submission‑ready package with fewer manual handoffs.

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Traceability Across Deliverables

All generated outputs remain connected to the underlying workflow steps. This traceability supports internal review processes and regulatory inspection readiness.