Presentation: SAS Drug Development Project Background - GAP analysis: needs vs. existing systems - Solution identified Experience insofar – next steps

Biometrics Clinical DB System Needs: Ensure regulatory compliance (21 CFR Part 11) Global Clinical Database Global standards Support electronic submissions Support medical monitoring

Biometrics Clinical DB System Existing systems: Not 21 CFR Part 11 compliant No global access Accessibility is controlled in an inefficient way No tools for ensuring global standards No data exploration / browsing capabilities Security aspects: data sent by e-mails No support to electronic submissions

Biometrics Clinical DB System Solution: SAS Drug Development: technically supports Part 11 is accessible through a web browser built in system for access control (enables and encourages standards e.g. CDISC)

Biometrics Clinical DB System Solution: SAS Drug Development cont.: supports data exploration capabilities all information and data will be accessed / analysed through a firewall supports electronic submissions

Functional Departments SDD Platform Application Information Management SAS Drug Development Pharma Functional Departments SDD Platform Application Data Sources EDC / Clinical Sites Genomic Data LIMS MS Access MS Word Flat File MS Excel AE Coding System Clinical Data Exploration Analysis and Reporting Firewall Internet T1 56K DSL Clinical Data Warehouse Web Hosting Server(s) Repository Biometrics Information Management Partners and Agencies Firewall Internet T1 56K DSL Clinical Develop. Partners Global Offices CROs FDA

SAS Drug Development Users of the system: Biometrics Clinical

SAS Drug Development Data Exploration Capabilities Sorting Data can be sorted in ascending or descending order and by multiple columns Filtering e.g. males < 65 yrs old

SAS Drug Development Exclusion Data can be excluded from further exploration Analysis Basis univariate and categorical summaries can be produced

SAS Drug Development

SAS Drug Development Derivation New variables can be derived from existent Contributing data Contributing data for a single patient can be accessed.

SAS Drug Development

Project Implementation SDD Project Project Implementation

SDD Project Project Start: QIV 2004 SDD: not faster than its shadow but bringing law and order into clinical data making it safe for anyone (granted access) to explore data.

SDD Project Project Start: QIV 2004 Go Live: 31/Dec/2006

SDD Project

SDD Project Main issues: Performance Change in internal procedures Lack of internal resources Data migration

SDD Project Next steps: - better performance - rollout of access for clinical - extended use of SDD functionality - non-clinical data - clinical data from affiliates