Waban SCE

Waban SCE for Clinical Biostatistics provides a secure, 21 CFR Part 11 compliant, controlled statistical computing environment (SCE) where routine and repetitious statistical programming and analysis jobs can be automated and tracked. It also supports exploratory data analysis where users can browse and explore data and create analytical datasets in a variety of formats with ease.

Manage Your Clinical Data, Analysis & Reporting
Waban SCE lets users examine, analyze, and annotate that data while maintaining complete audit trail of analyses and reports. A programming environment ensures that the source code for statistical data analysis and the data and the analysis itself are maintained in a version-controlled environment.

All objects are versioned and the job control component ensures that standard reports such as the creation of a binder can be automated and tracked. Further, complete traceability from the source datasets through the analysis programs to the output is maintained by managing inputs and outputs. The system supports the direct publication of reports from the statistical computing environment to the document management systems for submission by regulatory affairs.

Waban SCE key features include:

• A Secure Repository for Data, Programs & Reports
• Data Transformation to SDTM Standard
• Extract Data from Clinical Data Management, an EDC System (e.g., InForm®, Oracle® Clinical® and Clintrial®), or from Your Local Directory
• Integration with SAS®, S+®, WinNonlin® and R)
• Check-in, Check-out, Version Control and Audit Trails
• Object Status Management
• Integrated Programming and Execution Enviornment
• End-to-End Traceability of Dependencies
• Project Metrics and Management Dashboard
• Comprehensive Metadata Management
• Ability to Create Define.pdf and Define.xml
• 21 CFR Part 11 Compliance
• CDISC (SDTM and ADaM) Compliance
• Link Analyses and Reports to Data for Complete Traceability
• End to End Traceability of the Data