A company with whom a drug or device manufacturer or sponsor contracts to perform clinical trial related activities. CROs may contract to develop protocols, recruit patients, collect and analyze data, and prepare documents to submit marketing applications to FDA.
General term referring to a company under agreement with a pharmaceutical manufacturer to implement a specific component of the drug discovery/research (pre-clinical) or drug development (clinical trials phases I, II and III) process.
A commercial organization contracted by a client to perform one or more research-related functions
Helvetica an organization hired by a sponsor to perform some or all activities involved in a clinical trial
A company funded by the sponsor to manage the day-to-day aspects of the clinical trial.
A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor's study-related duties and functions.
A clinical services company involved with various steps in the clinical trial process from study design to trial execution and data management.
A company contracted by the sponsoring entity to manage specific parts of a clinical trial.
Controlled Release Formula Cooperative Research and Development Agreement (CRADA)
For a clinical trial, independent contractor to a sponsor who assumes some of the sponsor's obligations, e.g., protocol design. Go to definition 21 CFR 312; go to full 21 CFR 312.
A Contract Research Organization (CRO) is an organization that offers clients a wide range of pharmaceutical research services. In the Code of Federal Regulations (CFR), the U.S.