SAS Drug Development Presentation Project Background GAP analysis

SAS Drug Development Presentation: 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

SAS Drug Development Data Sources LIMS Data Clinical Data Warehouse Analysis and Reporting Web Hosting Server(s) Repository Firewall Data Exploration Internet Clinical Genomic Data AE Coding System Pharma Functional Departments SDD Platform Application T 1 56 K DSL EDC / Clinical Sites Information Management MS Word MS Excel Flat File Firewall MS Access Internet Partners and Agencies Clinical Develop. Partners Global Offices CROs T 1 56 K DSL FDA Biometrics

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 for a single patient can be accessed.

SAS Drug Development

SDD Project Implementation

SDD 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 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