Deciding Where CDISC Standards Will Provide the Most Improvement to Clinical Trials

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ID Number: G00139602

This research is provided for historical perspective;
portions of this document may not reflect current conditions.

11 May 2006

Carol Rozwell Michael Smith

As life science manufacturers realize the transactional nature of clinical trials, the value of clinical data interchange standards increases. But with so many choices, CIOs must help their organizations decide where implementing standards will provide the most benefit.

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Table of Contents

Analysis

1.0

Introduction

2.0

Standards Adoption Builds Momentum

3.0

Metrics for Process Improvement

3.1

Government Initiatives Encourage the Use of Standards

4.0

Hurdles to Standards Adoption Remain

5.0

Recommendations for Developing a Successful Standards Adoption Plan

Recommended Reading

List of Figures

	Figure 1.	Cost and Benefits of Standards Adoption Based on Clinical Trials Stages

	Figure 2.	Data Flows Using the CDISC Standards

	Figure 3.	The Impact of Using CDISC Standards on Selected Performance Indicators

	Figure 4.	FDA Interactions During Drug Development

Clinical Trials Management
FDA Regulations
Enterprise Information Management

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Resource Id: 492367