Solution Brief
Clinical Trial Data Analysis and Submission
Get therapies to patients faster with more productive, regulatory-compliant clinical trial analytics
The issue
Getting therapies to patients faster goes hand in hand with maximizing returns from R&D investments. Both require that clinical development teams gain rapid regulatory submission and approval of new products. To achieve their goals, teams must modernize clinical trials while maintaining data standards and regulatory compliance, integrating novel data sources and investigating emerging issues.
Getting therapies to market faster requires a clinical trial analytics ecosystem that outperforms legacy tools and methods while maximizing efficiency in the collection, analysis and submission of clinical trial data to regulators. Clinical development teams need tools to integrate validation, version controls, audit trails and documentation to avoid delays and rework. Streamlining submissions also requires automated workflows, integration support and data standards management. Ultimately, teams will need to pursue analytical rigor and compliance while addressing new complexities such as the growing level of patient centricity and the explosion of real-world data. And, they’ll need to use the latest AI and advanced analytics tools, including GenAI, to drive speed to market and clinical innovation.
The challenge
Accelerate submission and time to market while ensuring regulatory compliance
Study start-up and clinical development timelines must be compressed to get therapies to market faster. At the same time, clinical development teams need to uphold data standards and regulatory guidelines to avoid rework and reduce the risk of noncompliance.
Manage and analyze new data sources
Modern trial designs, decentralized trial methodologies and greater use of real-world data create an influx of data and new complexities.
Improve patient centricity
Clinical trials must be accessible and convenient to representative and diverse patient populations.
Balance collaboration and governance
Clinical trial stakeholders must collaborate across global clinical trials, and among sponsors and clinical research organizations, without compromising traceability and data governance.
(A single, open and cloud-native platform.; A secure, centralized repository for data and analytics.; Seamless integration for all stakeholders across geographies.; Transparent insights and trustworthy AI.)
Our approach
As a market leader in clinical trial analytics, SAS provides a secure analytics foundation and scalable framework for clinical trial data analysis and submission.
We approach the problem with clinical data analysis software and services to help you:
Accelerate speed to market
Submit new therapies faster and more efficiently.
Attain results you can trust
Avoid delays in regulatory submissions and reduce the risk of noncompliance while providing reliable, transparent and valid insights.
Increase operational efficiency
Improve processes and performance to boost ROI and gain better outcomes for patients.
Modernize clinical research
Increase the organization’s analytical maturity and foster innovation in clinical development. Enable trustworthy AI with embedded model interpretability, fairness and bias monitoring.
Using robust analytics tools and techniques – including AI and analytics for IoT – SAS® helps your organization accelerate R&D innovation in a heavily regulated world. Our customers gain efficiencies in getting trials up and running, modernizing trial designs and delivering life-changing therapies to patients.
SAS difference
The proven SAS statistical computing environment provides a universal approach to collecting raw data from clinical trials, managing and analyzing it, and presenting final data in easy-to-understand visuals for regulatory submissions. SAS has a long history of providing these capabilities to life sciences organizations of all sizes.
SAS delivers faster insights through:
- A single, open and integrated end-to-end platform.
- Seamless, secure integration across users, geographies and external partners.
- Near-real-time access to all data.
- Rapid GxP-qualified deployment by SAS managed services.
SAS reduces risk with:
- A secure, centralized repository that meets regulatory requirements.
- Auditable actions, data tracing and repeatable analysis.
- More than 20 years of standards-compliant implementations.
SAS improves operational efficiency by:
- Accelerating study start-up and optimizing study enrollment.
- Running simulations to keep studies on track and inform site supply.
- Using real-world data to guide operational decisions.
SAS helps modernize clinical trials by:
- Looking beyond compliance to collaboration and new data insights.
- Supporting modern, decentralized clinical trial designs.
- Empowering the use of large language models, digital twins and synthetic data in a transparent and explainable manner.
- Fully integrating with open source software.
- Scaling seamlessly from pilot to enterprisewide implementation.
SAS in life sciences
1
45
countries with customers in life sciences
0
2350
life sciences customers worldwide
-30
100
life sciences companies in the Fortune 500 use SAS