More Related Content Similar to d-Wise | SAS Clinical Data Integration (20) d-Wise | SAS Clinical Data Integration 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
5. Copyright © 2006, SAS Institute Inc. All rights reserved.
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"
6. Copyright © 2006, SAS Institute Inc. All rights reserved.
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
7. Copyright © 2006, SAS Institute Inc. All rights reserved.
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
8. Copyright © 2006, SAS Institute Inc. All rights reserved.
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
11. Copyright © 2006, SAS Institute Inc. All rights reserved.
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
12. Copyright © 2006, SAS Institute Inc. All rights reserved.
Domain Level Metadata
SDTM Implementation Guide
Column Level Metadata (all columns)
13. Copyright © 2006, SAS Institute Inc. All rights reserved.
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
15. Copyright © 2006, SAS Institute Inc. All rights reserved.
CDISC Metadata Reporting is Domain Driven
17. Copyright © 2006, SAS Institute Inc. All rights reserved. Company confidential - for internal use only
18. Copyright © 2006, SAS Institute Inc. All rights reserved.
Change Management Audit Study
Change Management
19. Copyright © 2006, SAS Institute Inc. All rights reserved.
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?
21. Copyright © 2006, SAS Institute Inc. All rights reserved.
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
22. Copyright © 2006, SAS Institute Inc. All rights reserved.
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?
Editor's Notes Carl leads
John leads
John leads
Michael leads
These domains are managed in the metadata- there is no use of table shells or databases to represent these data.
Michael leads
SAS Data Integration Studio is a visual metadata driven application that focuses on data processes.
The visual nature of the interface adds data relationships and associations to the metadata
Carl leads
Carl leads