WuXi PharmaTech and 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. The clinical operations of WuXi and PRA in China will combine to operate as an independent CRO and will be jointly owned by their respective parent companies.
WuXi will contribute clinical and regulatory experience to the JV from its China-based clinical organization. The organization covers all regions of the country and has employees working in 16 Chinese cities, with offices in Shanghai, Beijing, and Guangzhou. The agreement will provide services including clinical trial monitoring, project management, regulatory strategy and submissions, data management, biostatistics, drug safety reporting, and medical monitoring. WuXi will also supply laboratory services to the JV through a preferred provider arrangement.
PRA offers the venture global resources and clinical research expertise, reflected in more than 3,100 studies conducted over the last five years and contributions to 40 approved drugs in several therapeutic areas. PRA will also support the venture with 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.”
In August, PRA opened a second office in the central business district of Beijing to accommodate its expansion in China and the Asia Pacific region. PRA established its first China office in Shanghai in 2005.
WuXi PharmaTech, reportedly China’s largest contract research organization, invested $4.3 million as of December 31, 2011, in an undisclosed number of companies, to commercialize their new technologies.