The Contract Research Organization (CRO) originated in the United States in the early 1980s. It is an academic or commercial research institution that provides specialized services in basic medicine and clinical medicine research and development for pharmaceutical enterprises, medical institutions, small and medium-sized medical device research and development enterprises and even various government funds through contracts.
According to the nature of work, CRO can be roughly divided into Pre-Clinical)CRO and clinical CRO. The clinical research of CRO is mainly based on clinical trials.
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As a new industry, CRO originated in America in the early 1980s. At that time, with the FDA's strict and perfect regulations on the management of new drug research and development, the process of drug research and development became more complicated, time-consuming and expensive. Pharmaceutical enterprises are gradually facing various pressures from the following aspects.
1. According to statistics, a new drug needs about $350 million from laboratory discovery to market in the United States. The high failure rate of new compounds means that the investment risk in the subsequent development stage is greater. As far as a global phase III clinical trial is concerned, its cost is generally above $6,543,800+million.
2. From the time point of view, it takes an average of about 12 years for a new drug from discovery to marketing, and the extension of research and development period shortens the patent protection period after marketing. Especially for a drug with a large sales volume, every delay of 1 day means that the annual income is reduced by 1 10,000 USD.
3. At the same time, since 1980s, the biotechnology industry based on the discovery of new therapeutic drugs began to develop rapidly, and an innovative drug branch was formed.