SAS^® Life Science Analytics Framework Features

Information management

• Consolidation of clinical information into a single, secure, centralized global repository.
• Review of specific data set versions used, log files created, SAS programs executed and results generated.
• Rapid result reproduction.
• Tracing of data pedigree back to source data.
• Rapid answering of regulatory inquiries concerning data pedigree, transformations or analytical results.
• Ability to readily determine what audit changes were made, when and by whom, for all content stored in the repository.
• Executed program manifests that document all inputs, programs and results that are associated with an execution run for retention of all data and metadata necessary to analyzing results.

Statistical analysis & regulatory controls

• Seamless integration with SAS programming and program execution environments.
• Full control over SAS job execution.
• Ability to easily load and utilize standard analytic programs.
• Check in/out, audit trails, electronic signatures, versioning and role-based privileges.
• Quick reproduction of results using a job manifest (complete hyperlinked documentation package for each job that includes programs, data, logs and results).
• Control of all information via secure logins, audit trails, versioning and role-based privileges and policies.
• Ability to integrate with CTMS and document management systems..
  

Analytical data preparation

• Full mapping of data source, data manipulations and final destination for data.
• Impact analysis, reporting on (and helping to plan for) impact of any change to the process, including changes to incoming data formats and data standards or additional data requirements for analysis data sets.
• Automated data loads for clinical data on a more frequent schedule.
• Data extraction from Medidata Rave and other leading EDC systems.
• Connectable with EHRs and wearables and sensor data.
• Ability to integrate with third-party coding systems.

CDISC data standards support (model-driven)

• Standards governance.
• Study metadata management.
• Cell-based editing for adding and modifying metadata.
• User interface provides validation against model.
• Integration with Pinnacle21 (community and enterprise versions).
• Import Define-XML 2.0.
• Create Define-XML 2.0 (complete with style sheet).
• Data standards comparison reports.

Workflow optimization

• Assignment of tasks and progress tracking for each analysis activity and each deliverable.
• Support for workflow on multiple analyses, including interim and final analyses.
• Flexible access rights and privileges by project.

Integration of pharma analytics applications

• Integrate analytics applications – either user-developed or purchased from SAS – for a variety of business needs, including:
  • Risk-based scoring and monitoring.
  • Selection of the best investigator sites.
  • Recruiting clinical trial participants.
  • Improving safety surveillance and post-marketing activities.
  • Supporting medical monitoring programs.