Gartner Research

Best Practices for Risk-Based Monitoring in Clinical Studies

Published: 10 January 2013

ID: G00238147

Analyst(s): Steven Lefebure

Summary

Clinical monitoring is the largest single cost of a life science clinical study, and long-held operational paradigms preventing change are breaking apart. These technology-enabled best practices can help clinical development drive transformation of this critical business process.

Table Of Contents
  • Key Challenges

Introduction

Analysis

  • Establish a Productivity Foundation for Clinical Monitors That Leverages Mobility
  • Establish a Policy for Risk-Based Source Data Evaluation
  • Modernize the E-Clinical Application Environment
  • Invest in Clinical Analytics Technology to Identify Operational and Clinical Patterns That Require Action
  • Benefit/Cost Considerations

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