In today's rapidly evolving health care landscape, pharmaceutical and biotechnology companies face mounting pressure to accelerate drug development while maintaining rigorous compliance with global regulatory standards. And the influx of real-world, biomarker and digital protocol data; hybrid and decentralized trial designs; and increasing demand for patient centricity have introduced new complexities that legacy systems struggle to manage efficiently.

To address these challenges head-on, SAS - a global leader in clinical research analytics - today announced the general availability of SAS Clinical Acceleration. The cornerstone solution built on the SAS^® Viya^® platform modernizes and streamlines clinical trial data management, analysis and regulatory submission for life sciences organizations.

"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. "By supporting integration with open source technologies and providing robust compliance features, SAS is addressing key industry challenges and empowering teams to collaborate more effectively across the clinical development life cycle."

SAS will be presenting the new solution at PHUSE EU Connect, Nov. 16-19 in Hamburg, Germany. Conference attendees are invited to join live demo sessions in the SAS booth , meet SAS experts and hear the latest news about AI, analytics and automation in life sciences.

Engineering modern clinical trial analytics

SAS Clinical Acceleration is a modular, open, cloud-native content repository and statistical computing environment that enables clinical development teams to manage, analyze, report and review clinical research and medical data in a validated environment. Through auditable actions, data traceability and repeatable analyses, users can avoid costly delays in regulatory submission, reduce the risk of noncompliance and improve processes that streamline the path to submission.

The solution supports accessibility for all user types, featuring no-code/low-code interfaces, open source integration, open data formats and the ability to host anywhere. It provides a single source of truth for regulated clinical trial operations, enabling seamless collaboration among sponsors, clinical research organizations and regulatory bodies.

The unique benefits of SAS Clinical Acceleration include:

• Centralized global repository: The solution consolidates clinical information into a single, secure, centralized hub for improved data management and analytical data preparation, providing full tracing back to source data. SAS Clinical Acceleration Repository is available as a standalone repository solution or with the statistical computing environment as part of SAS Clinical Acceleration.
• Regulatory compliance & data security: SAS Clinical Acceleration supports compliance with the FDA's Title 21 CFR Part 11 requirements via audit trails, electronic signatures, versioning and role-based privileges. It also supports CDISC and its initiatives - dataset-JSON and CDISC CORE.
• Embedded AI: The platform supports modernization and leveraging generative AI and AI agents, including LLMs, digital twins and synthetic data, in a transparent and explainable manner.
• SAS Viya benefits: Through SAS Clinical Acceleration, organizations can leverage the benefits of SAS Viya - an end-to-end platform across the entire data and AI life cycle - including industry-leading visualizations, access modules, and jobs and flows in a controlled environment.
• Seamless integrations: The platform supports integration with electronic data capture (EDC), validation tools and metadata repositories.

Accelerating the path from data capture to submission

"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."

Future enhancements for the solution include workflow automation and expanded analytics capabilities, including integration of AI agents and copilots.

Learn more about how SAS delivers the most productive AI platform to transform data into life-changing insights and accelerate breakthroughs in life sciences here.