Contract Research Organization (CRO).
Origined in the United States in the early 1980s, it provides contracts for pharmaceutical companies, medical institutions, small and medium-sized pharmaceutical and medical device R&D companies, and even various government funds in the basic and clinical medical research and development processes. An academic or commercial scientific institution that provides specialized services.
According to the nature of the work, CRO is roughly divided into pre-clinical research (Pre-Clinical) CRO and clinical research CRO. Clinical research CROs mainly accept commissioned clinical trials (Clinical Trial).
At first, CRO was introduced to China and was limited to clinical services. Later, it was expanded to the entire process of drug research and development, from compound screening to post-market promotion of drugs. The scope of services is wide and can meet the needs of drug research and development enterprises. Different needs.
CRO provides research services at a certain stage and a certain part based on its own advantages. Such as agency drug registration application and clinical trial approval, translation and preparation of application materials, drafting and improvement of trial protocols, selection of researchers and participating units, process optimization, preparation services, formulation of standard operating procedures (SOP), and regulatory services , data collection, product support, etc.
Now one-stop service has become a trend. For pharmaceutical companies, it is very efficient to obtain multiple services from one CRO company, and the overall cost will be reduced. Therefore, CRO companies are increasingly moving towards providing comprehensive drug research and development services.
Origin
This type of organization originated in the United States about 25 years ago. With the improvement of drug research and development management by the U.S. Food and Drug Administration, the new drug research and development process has become more complex. It is complex, time-consuming and costly, mainly reflected in the following aspects:
1. The success rate of new drug clinical trials is reduced, subsequent development costs increase, and investment risks increase.
2. The research and development time of new drugs is extended, and the patent protection period enjoyed after marketing is shortened, and the profits of the drugs are subsequently reduced.
3. The tightening of public health expenses suppresses the market price of new drugs.
4. The variety of cheap common drugs has increased, and the profits of the original drugs in the market have decreased.
In an environment with increasingly strict management and fierce competition, the pharmaceutical industry can use contract research organizations with clinical research experience to perform certain tasks in clinical trials, which can improve the success rate of new drug clinical trials and improve the success rate of clinical trials. Reduce new drug research and development costs and increase profits. Therefore, such institutions are also the product of social division of labor, specialization and risk equalization.
Reference for the above content? Baidu Encyclopedia-Contract Research Organization