SAS Clinical Acceleration

SAS Clinical Acceleration is a cloud-native platform that combines a secure clinical data repository with a statistical computing environment (SCE) built on SAS Viya. It is designed for life sciences organizations that need to integrate, manage, validate, analyze and submit clinical research data in a compliant and auditable way. The platform is available either as a full solution — repository plus SCE — or as a standalone repository (SAS Clinical Acceleration Repository) for organizations that require only the data management component.

The platform targets clinical research teams, regulatory affairs groups and data scientists who work with diverse data sources such as electronic data capture (EDC) systems, clinical data management systems (CDMSs), laboratory systems and contract research organizations (CROs). It consolidates these sources, including real-world data, into a single, centralized hub to reduce manual effort and accelerate time to regulatory submission.

Key Benefits

• SAS Viya functionality in a controlled environment: Teams can use visualizations, collaborative workflows, access modules, and jobs and flows within a governed clinical research environment.
• Multilanguage support: Users can perform analyses using SAS, R or Python within a single, validated and governed platform, supporting diverse programming needs.
• Regulatory risk reduction: Auditable actions, data traceability and repeatable analyses help organizations avoid compliance delays and accelerate regulatory submissions.
• Data integrity and compliance: The platform supports roles, permissions, electronic signatures, version control and audit trails to maintain data integrity throughout the clinical data life cycle.
• Integration of large and diverse data sets: Data from EDC systems, CDMSs, labs and CROs can be consolidated into a single repository, enabling faster preparation, validation and analysis.

Core Features

• Centralized global repository: Consolidates clinical information into a single, secure hub with full traceability back to source data. Available as a standalone solution or as part of the full SAS Clinical Acceleration platform.
• Single, open, cloud-native SCE: Provides an end-to-end environment for clinical analysis and submission on SAS Viya, including everything needed for validation.
• Regulatory compliance and data security: Supports FDA Title 21 CFR Part 11 requirements through audit trails, electronic signatures, versioning and role-based privileges. Also complies with CDISC standards, including dataset-JSON and CDISC CORE.
• Maximum flexibility: Supports open source integration, open data formats, accessibility for all user types and the ability to host in any environment.
• Shared, scalable platform: Enables collaboration across geographies and with outsourced partners through a shared SAS Viya environment where all user types can work together.
• Embedded AI: Supports the use of generative AI, AI agents, large language models (LLMs), digital twins and synthetic data in a transparent and explainable manner to improve clinical trial efficiency over time.
• Seamless integrations: Supports integration with EDC systems, validation tools and the metadata repository.

How SAS Clinical Acceleration Supports Regulatory Submissions

1. Centralizes clinical data from multiple sources into a single, secure repository.
2. Automatically tracks data lineage and maintains full traceability to source data.
3. Ensures reproducible and auditable analyses through version control and electronic signatures.
4. Enables collaborative analysis across teams and geographies.
5. Prepares submission-ready data packages that comply with FDA 21 CFR Part 11 and CDISC standards.

Supported Data Types and Sources

• Programs, documents and PDFs from EDC systems, CDMSs, lab systems and CROs.
• Real-world data integrated alongside traditional clinical trial data.
• Any data type required for clinical analysis and regulatory submission.

SAS Clinical Acceleration is related to other SAS life sciences offerings, including SAS Health Solutions and SAS Life Science Analytics Framework. The platform is cloud-native and can be hosted in various environments, supporting organizations that need flexibility in deployment while maintaining the validation and compliance requirements of clinical research.