Scaling submission automation with SAS Clinical Acceleration on Viya

Clinical programming teams are under pressure to deliver submission-ready data faster, with fewer handoffs and less rework. SAS Clinical Acceleration on Viya is designed to help life sciences organizations modernize that path by combining controlled clinical data management, validation, analytics, and submission output generation in one governed environment.

A new model for submissions

For years, submission delivery has depended on a patchwork of code, spreadsheets, manual checks, and document assembly. That approach can work for a single study, but it becomes fragile when scaled across programs, therapeutic areas, vendors, and global regulatory timelines. SAS Clinical Acceleration on Viya addresses that problem by centralizing data, automating lineage tracking, and supporting collaborative analysis in a validated platform.

What makes this approach different is that it is not just a compute environment. It combines a secure clinical data repository with a statistical computing layer, built for regulated work and aligned to submission needs. The result is a more repeatable process for moving from raw clinical data to SDTM, ADaM, review-ready outputs, and regulatory packages.

Automated derivations at scale

One of the biggest gains comes from reducing repetitive derivation work. In a traditional setup, SAS programmers often rebuild similar SDTM and ADaM logic study after study, with variation introduced by local conventions, vendor differences, or late changes to specifications. SAS Clinical Acceleration supports reusable, standardized workflows so derivations can be applied consistently across studies and batches.

That matters for programming directors and study teams because it shifts effort from manual construction to controlled reuse. Instead of maintaining multiple isolated code streams, teams can run chained programs in batch, preserve traceability, and keep execution in one qualified environment. SAS Viya supports SAS, R, and Python in a governed setting, which helps open-source programmers contribute where appropriate without fragmenting compliance controls.

Validation built into workflow

Validation is often treated as a separate checkpoint, but in a scaled submission model it needs to be part of the workflow itself. SAS Clinical Acceleration includes validation capabilities, audit trails, electronic signatures, versioning, and role-based privileges to support compliance with 21 CFR Part 11 and CDISC-related standards.

That embedded control structure helps teams avoid late-stage surprises. Conformance checks, traceability reviews, and reproducibility controls can be applied as part of routine execution rather than as a manual end-of-line exercise. For compliance leaders, that means stronger inspection readiness; for programmers, it means fewer downstream reruns caused by missing checks or undocumented changes.

Submission-ready output generation

A major bottleneck in clinical development is not only analysis, but assembly. Final submissions require datasets, metadata, define.xml, documentation, and reviewer support materials to line up cleanly and consistently. SAS Clinical Acceleration is positioned to support that end-to-end flow by integrating analysis, validation, and submission preparation in the same environment.

That integrated model reduces the risk of version mismatch between outputs, metadata, and supporting documents. It also helps teams move faster because the final package is produced from the same governed source of truth used for derivations and review. In practice, this can shorten the path from database lock to submission-ready package while improving confidence in the final deliverables.

Why leadership should care

For directors of programming and IT, the business case is straightforward: less manual effort, fewer defects, faster cycle times, and more predictable delivery. SAS positions Clinical Acceleration as a cloud-native platform that helps manage, validate, analyze, and submit clinical research data more efficiently, with scalable analytics and collaborative workflows on Viya.

For compliance teams, the value is governance and traceability. For SAS programmers, it is reusable logic and a controlled execution framework. For open-source contributors, it is the ability to bring Python or R into a regulated workflow without losing oversight. That combination is important because modern clinical development increasingly depends on hybrid teams and hybrid methods.

Operating at enterprise scale

The real promise of Viya is scalability across studies and portfolios. Containerized, cloud-native execution supports broader deployment models, whether on-premises or in the cloud, while still preserving controlled access and auditability. SAS also highlights integrations with EDC, validation tools, and metadata repositories, which are essential for enterprise-scale clinical operations.

This matters when organizations need to run many studies in parallel, support external partners, and standardize submission practices across regions. Instead of treating automation as a point solution for one protocol, leaders can use Clinical Acceleration to establish a submission factory model: standardized inputs, governed derivations, automated checks, and packaged outputs ready for regulatory review.

Closing perspective

Scaling submission automation is no longer just an efficiency initiative; it is a strategic capability for modern clinical development. SAS Clinical Acceleration on Viya gives life sciences organizations a practical path to automate derivations, embed validation, and generate submission-ready output in a governed, reproducible way.

For leadership teams, the payoff is clearer timelines, better inspection readiness, and a stronger foundation for future innovation. In a landscape where speed and compliance must coexist, that combination is especially valuable.

Learn more

The SAS Clinical Acceleration Repository: A Game Changer for Clinical Research

Accelerating Clinical Analytics: Your Path from SAS LSAF or SAS 9 to SAS Clinical Acceleration

Transforming Clinical Programming With SAS Clinical Acceleration

Accelerating Clinical Trial Innovations With SAS Viya and Generative AI