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

scussions with executives and facility visits in China. A detailed cost comparison between China and US-based CRO's shows that study savings of between 35-50% are achievable and that these savings are likely to continue through 2012.

The cost savings associated with using CRO preclinical services in China are discussed in this report in the context of organizational and operational differences between CRO's based in the West and in China. A number of factors are presented that study sponsors must consider before committing to a Chinese CRO. Small- and medium-sized companies can make their preclinical studies budget go further by using China-based CRO's through appropriate due diligence and upfront project planning. FDA and EU regulators have accepted preclinical data generated by China-based CRO's as described in the report, and the FDA has begun to build a resident inspector network in China.

This report describes the impact that language skills and the shortages of key disciplines have on how best to structure preclinical studies in China. Also evaluated are the broad issues such as IP protection and CRO ownership as well as laboratory animal rights regulations. CRO's in China have access to large non-human primate breeding facilities and offer a clear advantage to those companies planning non-human primate studies. The report discusses the several Western laboratory mice, rat, and beagle dog vendors and well as feed providers operating in China.

Outsourcing Preclinical Studies to China: Benefits and Challenges presents an analysis of the current and near-term state of preclinical services available in China. The report begins with a short introduction to the evolution of preclinical services as well as a description of the three laboratory ownership categories. Chapter 2 presents the differences in organizational and operational structures, business practices, as well as personnel shortages and infrastructure issues. Chapter 3 pro
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