d-Wise offers an ability to reduce data integration efforts within Pharmaceutical clinical operations significantly with the implementation of SAS's Clinical Data Integration software. Discussion of the Opportunity, the Challenges, Data Quality Challenges, Integration Features, Benefits SDTM Implementation

1. Copyright © 2006, SAS Institute Inc. All rights reserved.
SAS Clinical
Data Integration
d-Wise

2. Copyright © 2006, SAS Institute Inc. All rights reserved.
Agenda
 d-Wise and SAS
 Industry Challenges
 CDISC Solution: SAS
 Value: Qualitative / Quantitative
 Package Profile
 Q&A

3. Copyright © 2006, SAS Institute Inc. All rights reserved.
d-Wise Technologies, Inc.
SAS Professional Services Partner and SAS Reseller
• Consulting
• SAS solutions
• SAS technology
• Custom system design and development
• #1 SAS partner for SAS Clinical Data Integration
• Industry Experience
• Pharmaceutical and Clinical Research
• Health Insurance and Medical Device Manufacturing
• Banking
• Commodities Trading and Portfolio Risk

4. Copyright © 2006, SAS Institute Inc. All rights reserved.
d-Wise Technologies, Inc.
Company Founders
• Chris Olinger
• Technical lead, SAS R&D – SAS Output Delivery
System (ODS)
• 20 years of SAS experience
• John Leveille
• Technical lead, SAS R&D – SAS/IntrNet product
• 15 years of SAS experience
• SAS Drug Development Team Members
• Technical Consulting Staff
• SAS BI and DI specialists
• Certified SAS developers
• Full life cycle, cross-industry experience

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SAS Clinical Data Integration Experience
 Registered CDISC provider
 Project Management methodology
 PMI Certified Project Managers
 Follow consulting best practices
 Experienced technical architects and domain
expertise
 Customer implementations for global
pharmaceutical companies and CROs"

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Pharma: Opportunity For Process Improvement
 $49.3 Billion R & D Spending - PhRMA 2004
 39-45% R & D Allocated: Clinical Trials
 30-50% Improvement by automating clinical trials
process: including use of data exchange
standards - Gartner
 Industry savings from automation & standards
$5.8-$6.6 Billion annually-30%
 35% of Trial Costs: Data Management &
Reporting $7.8 Billion
 50% of Phase III Trials Fail

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Clinical DI Landscape: Technology Challenges
 Inconsistent enterprise and application
architecture for integration
 Lack of standards / too many standards =
time & effort in IT and data management
 >30% of IT budgets typically spent on integration
 Fragile “spaghetti” integration maintenance
 Validation
 Manageability
 Performance
 Security
 Data Governance – what are the important systems

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Clinical DI Landscape: Data Quality Challenges
 Poor data quality costs U.S. businesses $600B 1
 Cost to the US economy >$1.5T 2
 Most data warehouse projects fail to achieve their
desired results due to data quality problems 3
 The number of organizations with a data quality plan
doubled between 2001 and 2005 4
1 “Data Quality and the Bottom Line: Achieving Business Success through a Commitment to High Quality Data.” The Data Warehousing Institute. Report Series 2002.
2 L. English, “Reversing the High Cost of Low Quality Information”, Proceedings of The 13th Information Quality Conference, San Diego, CA, 2003, p. 18.
3 Gartmer and META published research
4 http://www.tdwi.org/

9. Copyright © 2006, SAS Institute Inc. All rights reserved.
The SAS Clinical Data Integration Solution
Internal
Clinical
Data Mgmt
CRO
Data
Offshore
Lab
Data
EDC
Data Store
ODM
SDTM
CRT-DDS
(define.xml)
Clinical
Reporting
Data
Warehouse

10. Copyright © 2006, SAS Institute Inc. All rights reserved.
Clinical Data Integration Features
 Centralized management of Metadata
 Support for CDISC standards
 Flexible implementation options
 Incorporates data quality management
 Easily extensible
 Integrates with analytical environment
 Leverage existing IT investments

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SDTM Implementation Guide
 Centrally Accessible
 Contains All Domains
 General Purpose
 Special-Purpose
 Special-Purpose Relationship
 Trial Design
 Each Domain Contains
 Table Structure
 CDISC Table Level Metadata
 CDISC Column Level Metadata
 Allows For Custom Domain Expansion

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Domain Level Metadata
SDTM Implementation Guide
Column Level Metadata (all columns)

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SAS Data Integration Server
 Visual Standardization
Process
 Drives relationships and
associations
 End up with standardized
data AND specific
metadata about how data
was created

14. Copyright © 2006, SAS Institute Inc. All rights reserved.
SAS Clinical Data Integration Benefits
 Encourages you to build reusable data
management, analysis and reporting processes
for clinical studies
 Follows the CDISC STDM Implementation Guide
v3.1.1 (and will support v3.1.2 when it is
finalized). SDTM Model Verification.
 Allows for flexibility and customizations necessary
to implement SDTM+/-
 Enables control and security using SAS
Management Console
 CDISC Metadata Reporting is Domain Driven
 Change Management Auditing

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CDISC Metadata Reporting is Domain Driven

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Publish SDTM Library

17. Copyright © 2006, SAS Institute Inc. All rights reserved. Company confidential - for internal use only

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Change Management Audit Study
Change Management

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SDTM Model Verification
Foundation
Standards
Study
Study
Study
Do I have all my required variables?
Do column names, descriptions, types, match?
Do all required variables have data?

20. Copyright © 2006, SAS Institute Inc. All rights reserved.
Verification Report

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SAS Clinical Data Integration Package
 Requires licensing of SAS 9 and Data Integration
Server
 Deliverables include:
 Architecture Design
 Review of hardware configuration
 Installation of STDM model following the CDISC
Implementation Guide v3.1.1
 Initialization of study repository

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SAS Clinical Data Integration Package
Onsite
Days
Deliverable Description
NA •SAS Software Licenses (is this normally included in
document or as an attachment?)
5 ♦High level results document
−Data source details, analysis, and architecture
−Infrastructure Recommendation
−Implementation Plan
♦Detailed roadmap and architecture
4 weeks ♦Startup Services
♦Detailed hardware specification
♦Detailed architecture plan
♦Documented installation and configuration (IQ/OQ)
of SAS software (including Metadata Server and
Metadata Framework)
♦Administrative procedures
♦Configuration management guidelines
♦Knowledge transfer
TBD ♦Un-bundled Services Available
♦Completion of data transformation case study
♦Report of case study and design document
♦Stored processes (code) that convert company
standard data formats to SDTM
♦Conversion of company program libraries to metadata
objects
♦Integration of CDISC processes with SAS Drug
Development
♦User Acceptance Testing/ System Validation

23. Copyright © 2006, SAS Institute Inc. All rights reserved.
SAS Clinical Data Integration
 Questions?