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

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

3. 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 s
No support to electronic submissions

4. 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)

5. 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

6. 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

7. SAS Drug Development
Users of the system:
Biometrics
Clinical

8. 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

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

10. SAS Drug Development

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

12. SAS Drug Development

13. Project Implementation
SDD Project
Project Implementation

14. 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.

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

16. SDD Project

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

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