What is a CRO in Life Sciences?
The full name is Contract Research Organization, which is a contract outsourcing service organization for new drug research and development. It primarily provides clinical research services for new drugs to pharmaceutical companies through contracts. A CRO has the ability to quickly assemble a highly specialized clinical research team with extensive experience and can reduce the overall management costs of the pharmaceutical company.
A CRO's work can cover all aspects of new drug research and development and trials. Depending on the different stages of drug development it covers, a CRO can be divided into preclinical CROs and clinical CROs.
A preclinical CRO primarily conducts laboratory studies and live animal studies on candidate drugs obtained from the compound research stage under laboratory conditions. This is done in order to observe the biological activity of the compound on the target disease and to conduct safety evaluations. The main services provided by a preclinical CRO include pharmacology studies, toxicology studies, and animal pharmacokinetic studies. In addition to these, preclinical drug research also includes the synthetic process of the drug, extraction methods, physical and chemical properties and purity, dosage form selection, prescription screening, preparation process, testing methods, quality indicators, stability, pharmacology, toxicology, and animal pharmacokinetic studies. In contrast, a clinical CRO provides outsourcing services for various stages of clinical trials for drugs.
A clinical CRO generally provides clinical trial technology services, on-site management, data management and statistical analysis, for drug clinical trials, including Phase I-IV clinical trials and BE trials. They also provide registration and declaration services.
