Reportlinker.com announces that a new market research report is available in its catalogue.
Reportlinker Adds Outsourcing Preclinical Studies to China
Within the past several years, a number of government labs as well as private and joint venture CRO's have or will soon offer preclinical GLP study services to Western clients. This report, built on discussions and facility visits to the most advanced labs, provides a detailed view of the current and evolving preclinical study capabilities in China, their structures and services, as well as an analysis of the comparative costs between US and China-based CRO's.
- Strategies being used by small, medium, and large pharmas in China
- FDA's willingness to accept preclinical data from Chinese labs
- Advantages of conducting non-human primate studies in China
- The importance of due diligence and project monitoring
- Options for managing China programs without an in-country presence
Outsourcing Preclinical Studies to China: Benefits and Challenges reviews the state of preclinical study services in China to identify the current level and near-term trends for compliance with Western GLP standards. Competition to supply CRO services is beginning to cause consolidation and attrition within China. A small number of key preclinical service providers, identified and profiled in this report, have emerged as strong CRO providers. Background material for this report was obtained through discussions 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.