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
Pharma
Functional Departments
SDD Platform
Application
Data Sources
Clinical
AE Coding
System
LIMS
Data
Clinical
Data
Warehouse
Analysis and
Reporting
Web
Hosting
Server(s)
Repository
Firewall
Data
Exploration
Internet
Genomic
Data
T1
56K
DSL
EDC /
Clinical Sites
Information Management
MS Word
MS Excel
Flat File
Firewall
MS Access
Internet
Partners and Agencies
T1
56K
DSL
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
Contributing data for a single patient
can be accessed.
SAS Drug Development
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