d-Wise | SAS Clinical Data Integration

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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

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  • 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
  • d-Wise | SAS Clinical Data Integration

    1. 1. SAS Clinical Data Integration d-Wise Copyright © 2006, SAS Institute Inc. All rights reserved.
    2. 2. 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.
    3. 3. 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.
    4. 4. 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.
    5. 5. 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.
    6. 6. 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.
    7. 7. 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.
    8. 8. 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.
    9. 9. The SAS Clinical Data Integration Solution ODM EDC Data Store SDTM CRO Data Offshore Lab Data Internal Clinical Data Mgmt Copyright © 2006, SAS Institute Inc. All rights reserved. CRT-DDS (define.xml) Clinical Reporting Data Warehouse
    10. 10. 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.
    11. 11. 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.
    12. 12. SDTM Implementation Guide Domain Level Metadata Column Level Metadata (all columns) Copyright © 2006, SAS Institute Inc. All rights reserved.
    13. 13. SAS Data Integration Server    Copyright © 2006, SAS Institute Inc. All rights reserved. Visual Standardization Process Drives relationships and associations End up with standardized data AND specific metadata about how data was created
    14. 14. 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.
    15. 15. CDISC Metadata Reporting is Domain Driven Copyright © 2006, SAS Institute Inc. All rights reserved.
    16. 16. Publish SDTM Library Copyright © 2006, SAS Institute Inc. All rights reserved.
    17. 17. Copyright © 2006, SAS Institute Inc. All rights reserved. Company confidential - for internal use only
    18. 18. Change Management Audit Study Change Management Copyright © 2006, SAS Institute Inc. All rights reserved.
    19. 19. SDTM Model Verification Foundation Standards Do I have all my required variables? Do column names, descriptions, types, match? Do all required variables have data? Study Study Study Copyright © 2006, SAS Institute Inc. All rights reserved.
    20. 20. Verification Report Copyright © 2006, SAS Institute Inc. All rights reserved.
    21. 21. 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.
    22. 22. 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 Copyright © 2006, SAS Institute Inc. All rights reserved.
    23. 23. SAS Clinical Data Integration  Questions? Copyright © 2006, SAS Institute Inc. All rights reserved.
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