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About China Preclinical Management Services

CPMS manages preclinical safety studies in China on behalf of Western biopharmaceutical companies. We reduce the risks and costs associated with conducting nonclinical safety studies across time zones. We combine on-the-ground, Chinese domestic expertise with Western compliance processes.  We oversee each stage of IND-enabling drug development and have been part of a number of successful INDs submitted to the FDA and EMEA. We have also co-authored a number of industry reports. 

History
Dr Bush began exploring questions regarding the GLP status of CROs in China with collaborative evaluations in 2006. During 2007 and 2008, more in-depth evaluations, including placement of GLP proof-of-concept studies took place, and the results of those studies indicated that a few of the top China labs had passed a tipping point on their abilities to meet Western GLP compliance expectations. CPMS was then launched to assist Western biopharma companies in leveraging the emerging opportunities in China. Over the past 4 years CPMS has evaluated over 15 facilities, monitored/audited over 20 GLP studies, and submitted data from these studies to support 4 US INDs. We believe that China will be an increasingly important source for GLP safety studies, and that resourceful managers in biopharma R&D can utilize Chinese CROs to gain significant advantages for their drug development programs.

 

CPMS was launched from within Cambridge Healthtech Associates (CHA), the leading facilitator of collaborations, consortia and communities within the life sciences industry. CHA reduces the costs of R&D by bringing companies together to cooperatively evaluate novel technologies, assess vendors in emerging markets and address areas of shared concern.  

 

 

Contact us for more information:


China Preclinical Management Services (CPMS)

Phone +1 781 972 1344

email

 

 

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