First CRO standard of our medicine industry is expected to come by the end of this year2011.08.16 08:48
On June 3rd,2009,the CROU of national medical technology market association (CFO) held the China contract research organizations clinical trial service management standard conference in Grand Gongda Jianguo Hotel.
The conference focuses on how to ensure,improve and perfect the quality of clinical research developing,as well as the promotion of quality management standards in the future in China, forming the normative standard files.In the conference,the participants around the first drafts formed in the prophase research,and spreading deep discussion according to quality management standard,quality management system,the frame of structure and standard content, and deeply discussed in issuing standard guidance technology documents aimed at CRO quality management systems.
What’s CRO? Contract research organization (Contract Research Organization),namely CRO is Pharmaceutical research and development outsourcing company rose in the United States in the late 70s.Accepting the entrustment of the pharmaceutical company, undertaking the most time-consuming and ardurous task of clinical trials are the company’s initial work.This helps to shorten the new product cycles of pharmaceutical enterprise,and speed up the process of appearing on the market.
CROU Secretary-general Gong Tinghua pointed out that China CRO industry has not been formed uniform industry system and macro management standards,the industry standard isn’t perfect, the discussion of the revising the contract research organizations clinical experiment service management standard,it will be the first industry standard in the CRO industry,and expected to be issued by the end of this year.This standard coming on the stage,will strengthen domestic CRO enterprise in clinical trials of the drugs on operation management and service management,so as to enhance China's drug clinical trials in the international organization of status and reputation.