JV will provide clinical trial monitoring, project management, regulatory strategy, data management and drug safety reporting
WuXi PharmaTech, a leading contract research organisation with operations in China and the US, has signed a joint venture agreement with PRA, a leading global clinical contract research organisation, to offer a broad platform of Phase I-IV clinical trial services in China, Hong Kong and Macau.
The joint venture will provide services 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 respective parent companies.
WuXi will contribute clinical and regulatory experience to the joint venture from its China-based clinical organisation. That organisation covers all regions of the country and has employees working in 16 Chinese cities, with offices in Shanghai, Beijing and Guangzhou. WuXi will also supply laboratory services to the joint venture through a preferred provider arrangement.
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 offers the venture a wealth of 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.
‘We are delighted to partner with PRA to build the leading clinical trial services operation in China,’ said Dr Ge Li, Chairman and CEO of WuXi PharmaTech. ‘China’s pharmaceutical market today is the third largest in the world and growing very rapidly. 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.
‘We aim to become the clinical trial service provider of choice in China with the highest quality standards and operational excellence.’
‘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,’ said Colin Shannon, President and CEO, PRA.
‘PRA’s global experience and technical expertise and WuXi’s operational experience and knowledge in China are a perfect fit. We look forward to working with WuXi to serve global life science companies conducting studies in China.’