Pharmaceutical and biotechnology companies face mounting pressure to accelerate drug development while maintaining rigorous compliance with global regulatory standards. SAS, a global leader in clinical research analytics, announced the general availability of SAS Clinical Acceleration, a comprehensive platform designed to modernize clinical trial data management and streamline regulatory submissions for life sciences organizations.
The new solution addresses critical industry challenges stemming from the influx of real-world data, biomarker information, and digital protocol data, alongside the growing complexity of hybrid and decentralized trial designs. Legacy systems have struggled to manage these evolving requirements efficiently, creating bottlenecks in the drug development process.
Comprehensive Clinical Data Management Solution
SAS Clinical Acceleration operates as a modular, open, cloud-native content repository and statistical computing environment built on the SAS Viya platform. The system enables clinical development teams to manage, analyze, report and review clinical research and medical data within a validated environment that ensures auditable actions, data traceability and repeatable analyses.
"As life sciences organizations face increasing complexity in clinical trial design and data management, solutions like SAS Clinical Acceleration are helping to modernize analytics environments, streamline regulatory submissions and enable faster delivery of therapies to patients," said Dr. Nimita Limaye, Research Vice President, Life Sciences R&D Strategy and Technology at IDC.
The platform provides a single source of truth for regulated clinical trial operations, facilitating seamless collaboration among sponsors, clinical research organizations and regulatory bodies through no-code/low-code interfaces, open source integration, and flexible hosting capabilities.
Key Platform Capabilities
The solution consolidates clinical information into a centralized global repository that serves as a secure hub for improved data management and analytical data preparation, with full tracing back to source data. This centralized approach addresses one of the most persistent challenges in clinical research: data fragmentation across multiple systems and stakeholders.
For regulatory compliance, SAS Clinical Acceleration supports FDA Title 21 CFR Part 11 requirements through comprehensive audit trails, electronic signatures, versioning and role-based privileges. The platform also supports Clinical Data Interchange Standards Consortium (CDISC) initiatives, including dataset-JSON and CDISC CORE standards.
The system incorporates embedded AI capabilities, supporting generative AI and AI agents, including large language models, digital twins and synthetic data generation in a transparent and explainable manner. These AI features represent a significant advancement in clinical trial analytics, potentially reducing the time required for data analysis and interpretation.
Industry Impact and Future Development
"Every day of delay in bringing a therapy to market can cost millions and impact patient outcomes," said Dr. Mark Lambrecht, Global Head of Health Care and Life Sciences at SAS. "With SAS Clinical Acceleration, we're empowering life sciences organizations to modernize their clinical analytics infrastructure, reduce submission timelines and collaborate more effectively across trials, phases and therapeutic areas."
The platform supports integration with electronic data capture systems, validation tools and metadata repositories, creating a comprehensive ecosystem for clinical trial management. This integration capability addresses the industry's need for interoperability across diverse technology platforms used in modern clinical research.
Future enhancements planned for the solution include workflow automation and expanded analytics capabilities, with particular focus on integrating AI agents and copilots to further streamline clinical development processes. These developments signal SAS's commitment to continuously evolving the platform to meet emerging industry needs.
SAS presented the new solution at PHUSE EU Connect in Hamburg, Germany, demonstrating the platform's capabilities to clinical research professionals and highlighting its potential to transform how life sciences organizations approach clinical trial analytics and regulatory submissions.
