A Contract Research Organization (CRO) is a company that provides outsourced research services to the pharmaceutical, biotechnology, and medical device industries. These laboratories are specialized facilities that provide a range of services to support drug discovery and development, including preclinical testing, clinical trials, and analytical testing.
Here are some of the services that CRO laboratories typically provide:
- Preclinical Testing: they conduct a range of preclinical studies to assess the safety and efficacy of new drug candidates. This includes in vitro studies to assess the drug’s mechanism of action, as well as in vivo studies to assess the drug’s safety and efficacy in animal models.
- Clinical Trials: they provide a range of services to support clinical trials, including study design, participant recruitment, site monitoring, and data management. CRO laboratories also provide specialized services such as pharmacokinetic analysis and bioanalytical testing.
- Analytical Testing: they provide a range of analytical testing services to support drug development, including drug substance characterization, stability testing, and formulation development. CRO laboratories also provide specialized services such as impurity analysis and method development.
- Regulatory Support: CRO laboratories provide support to clients in navigating the regulatory process, including preparing regulatory submissions and interacting with regulatory agencies.
CRO laboratories are typically staffed by highly trained scientists with expertise in areas such as pharmacology, toxicology, chemistry, and clinical research. The use of CRO laboratories can help to accelerate drug development timelines and reduce costs by providing specialized services and expertise on an as-needed basis.