d-wise | sas clinical data integration
DESCRIPTION
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 ImplementationTRANSCRIPT
Copyright © 2006, SAS Institute Inc. All rights reserved.
SAS Clinical Data Integrationd-Wise
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
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
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
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"
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
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
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/
Copyright © 2006, SAS Institute Inc. All rights reserved.
The SAS Clinical Data Integration Solution
Internal Clinical
Data Mgmt
CROData
OffshoreLabData
EDCData Store
ClinicalReporting
DataWarehouse
ODM
SDTM
CRT-DDS(define.xml)
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
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
Copyright © 2006, SAS Institute Inc. All rights reserved.
Domain Level Metadata
SDTM Implementation Guide
Column Level Metadata (all columns)
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
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
Copyright © 2006, SAS Institute Inc. All rights reserved.
CDISC Metadata Reporting is Domain Driven
Copyright © 2006, SAS Institute Inc. All rights reserved.
Publish SDTM Library
Copyright © 2006, SAS Institute Inc. All rights reserved. Company confidential - for internal use only
Copyright © 2006, SAS Institute Inc. All rights reserved.
Change Management Audit Study
Change Management
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?
Copyright © 2006, SAS Institute Inc. All rights reserved.
Verification Report
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
Copyright © 2006, SAS Institute Inc. All rights reserved.
SAS Clinical Data Integration PackageOnsite Days
Deliverable Description
NA •SAS Software Licenses (is this normally included in document or as an attachment?)
5 High level results documentData source details, analysis, and architectureInfrastructure RecommendationImplementation PlanDetailed roadmap and architecture
4 weeks Startup ServicesDetailed hardware specificationDetailed architecture planDocumented installation and configuration (IQ/OQ) of SAS software (including Metadata Server and Metadata Framework)Administrative proceduresConfiguration management guidelinesKnowledge transfer
TBD Un-bundled Services AvailableCompletion of data transformation case studyReport of case study and design documentStored processes (code) that convert company standard data formats to SDTMConversion of company program libraries to metadata objectsIntegration of CDISC processes with SAS Drug DevelopmentUser Acceptance Testing/ System Validation
Copyright © 2006, SAS Institute Inc. All rights reserved.
SAS Clinical Data Integration
Questions?