d-wise | sas clinical data integration

Copyright © 2006, SAS Institute Inc. All rights reserved.

SAS Clinical Data Integrationd-Wise


Agenda

d-Wise and SAS Industry Challenges CDISC Solution: SAS Value: Qualitative / Quantitative Package Profile Q&A


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


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


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"


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


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


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/


The SAS Clinical Data Integration Solution

Internal Clinical

Data Mgmt

CROData

OffshoreLabData

EDCData Store

ClinicalReporting

DataWarehouse

ODM

SDTM

CRT-DDS(define.xml)


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


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


Domain Level Metadata

SDTM Implementation Guide

Column Level Metadata (all columns)


SAS Data Integration Server

Visual Standardization Process

Drives relationships and associations

End up with standardized data AND specific metadata about how data was created


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


CDISC Metadata Reporting is Domain Driven


Publish SDTM Library


Change Management Audit Study

Change Management


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?


Verification Report


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


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


SAS Clinical Data Integration

Questions?