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Reportlinker Adds Outsourcing Preclinical Studies to China
Date:10/26/2009

vides a cost case study comparing preclinical study cost between the US and China. Chapter 4 provides a discussion of possible caveats and due diligence factors to be considered when considering placing a preclinical study in China. Chapter 5 provides profiles covering operations, facilities and services of the eleven most advanced CRO's in China.

About the Author: Eric A. Meyers, MBA, is a consultant to the drug development and medical device industries. His 20 years in the healthcare industry includes senior management positions with Fortune 50 companies and successful startups. Mr. Meyers is a recognized expert in drug development sectors in China and India, leading projects to assist both small and large pharmaceutical companies with their Asia drug development strategies. Mr. Meyers received both an MBA and a B.A. from Harvard University.

Chapter 1 - INTRODUCTION

1.1. Why China: The Current High Level Perspective

1.2 Why China: Motivation and Strategic Considerations for Assessing the China Opportunity

1.3. Why China: Emergence of the Preclinical CRO Sector

1.4. Why China: Trends in Safety Science Services and China's Role

1.5. Report Background and Content

Chapter 2 - THE STATE OF PRECLINICAL SAFETY SERVICES IN CHINA

2.1. Overview

Organizational History

High Profile Laboratories

SFDA Accreditation

SFDA vs. US/OECD GLP Standards

2.2. Industry Structure and Competitive Dynamics

SFDA Labs

Private Labs

Additional Observations

2.3. Industry Infrastructure

Language and Communication

Protection of Intellectual Property Rights and Confidential

Information

Facilities

Lab Space

Lab Automation Systems

Instrumentation

2.4. GLP Compliance

2.5. FDA Acceptance of Data,
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