Statistical Computing Environment

The Statistical Computing Environment (SCE) is designed to accelerate clinical research through powerful statistical programming. It centralizes clinical data analysis in a cloud-based environment, reducing the risk of errors and enhancing collaboration.

SCE supports advanced data analytics and real-time collaboration, accommodating most programming languages such as SAS, R, and Python. This environment is optimized for secure, high-quality data management, facilitating the creation of submission-ready reports.

Benefits

• Comprehensive Documentation: Enables the generation of complete study documentation packages.
• Collaborative Process Management: Enhances collaboration among stakeholders with notifications and process management tools.
• Performance Metrics Generation: Allows for the generation of performance metrics from transactional data and metadata.
• Efficient Versioning and Change Management: Manages versioning and changes effectively through an integrated repository.
• Enhanced Report Quality: Improves report quality and reduces errors with active data and metadata management.
• Secure Data Access: Provides secure access to system parts and allows for the secure deposit of new data, programs, and documents.
• Submission-ready Statistical Reporting: Facilitates the development of submission-ready statistical reports and exploratory analysis.

SCE is compliant with 21CFR11 and GxP standards, ensuring full traceability, transparency, and auditability. It integrates seamlessly with SAS, R, and Python applications and supports vendor-agnostic data storage, adhering to CDISC standards for metadata and data management.

The cloud-based architecture of SCE is scalable, capable of handling large and diverse datasets. Its intuitive user interface, featuring a modular design, streamlines workflows, standardizes templates, and promotes code reuse through automation.

Enhanced security measures reduce intellectual property and compliance risks with role-based data access and privileges, ensuring rapid responses to regulatory inquiries. The environment also supports rapid web-based statistical programming and development for quicker review and execution.