CRO WuXi PharmaTech, with operations in China and the U.S., and CRO PRA have signed a joint venture agreement to offer a broad platform of phase I-IV clinical trial services in China, Hong Kong and Macau, including clinical trial monitoring, project management, regulatory strategy and submissions, data management, biostatistics, drug safety reporting and medical monitoring.
The clinical operations of WuXi and PRA in China will combine to operate as an independent CRO and will be jointly owned by their parent companies. WuXi will contribute clinical and regulatory experience from its China-based clinical organization, which covers all regions of the country and has employees in 16 Chinese cities, with offices in Shanghai, Beijing and Guangzhou. WuXi also will supply laboratory services through a preferred provider arrangement.
PRA brings its resources and experience reflected in more than 3,100 studies conducted over the last five years and contributions to 40 approved drugs in several therapeutic areas. PRA also will contribute its China-based staff and global technology capabilities, encompassing data capture, trial management and other IT systems. The companies will market the joint venture’s services to their respective customers.
"China’s pharmaceutical market today is the third largest in the world and growing very rapidly," said Dr. Ge Li, chairman and CEO of WuXi PharmaTech. “Biopharmaceutical companies increasingly need sophisticated clinical-trial management services to gather the highest-quality data in Chinese patients to complete Chinese and international regulatory filings as quickly and successfully as possible.”
"PRA’s global experience and technical expertise and WuXi’s operational experience and knowledge in China are a perfect fit," said Colin Shannon, president and CEO of PRA. "Clinical trials continue to expand in China, and this joint venture is another step we are taking to meet the needs of our clients by establishing a strong presence there."
WuXi PharmaTech provides a portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process, designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. It subsidiaries operated as WuXi AppTec.
PRA has provided personalized service customized to the requirements of each study, in 80-plus countries for more than 30 years.