Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

d-Wise | SAS Clinical Data Integration

1,977 views

Published on

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

Published in: Technology
  • Be the first to comment

d-Wise | SAS Clinical Data Integration

  1. 1. Copyright © 2006, SAS Institute Inc. All rights reserved. SAS Clinical Data Integration d-Wise
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 12. Copyright © 2006, SAS Institute Inc. All rights reserved. Domain Level Metadata SDTM Implementation Guide Column Level Metadata (all columns)
  13. 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. 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. 15. Copyright © 2006, SAS Institute Inc. All rights reserved. CDISC Metadata Reporting is Domain Driven
  16. 16. Copyright © 2006, SAS Institute Inc. All rights reserved. Publish SDTM Library
  17. 17. Copyright © 2006, SAS Institute Inc. All rights reserved. Company confidential - for internal use only
  18. 18. Copyright © 2006, SAS Institute Inc. All rights reserved. Change Management Audit Study Change Management
  19. 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?
  20. 20. Copyright © 2006, SAS Institute Inc. All rights reserved. Verification Report
  21. 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. 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. 23. Copyright © 2006, SAS Institute Inc. All rights reserved. SAS Clinical Data Integration  Questions?

×