A contract research organisation (CRO) is a company that a drug company hires to run its clinical trials. The drug company that owns the medicine and pays for the trial is called the sponsor. Most sponsors do not have enough staff to run a large trial in many countries. So they hire a CRO, which has trained staff and working relationships with hospitals in many places.
A CRO does four main jobs. First, it recruits the hospitals that take part, and gets the approvals each one needs. Second, it monitors the trial. Its monitors, called clinical research associates, visit or call each hospital to check that patients are safe and that the trial plan is being followed. Third, it manages the trial's data. Fourth, it does the statistics and writes up the results for the regulator. The data and statistics work together is called biometrics.
Take, for example, a small vaccine company in Hyderabad that wants to test a new typhoid vaccine on 4,000 children at 25 hospitals in India. It hires a CRO. The CRO applies to CDSCO and to each hospital's ethics committee, and registers the trial on CTRI, the Clinical Trials Registry of India. It sets up the electronic data capture (EDC) forms. Its monitors visit each hospital every six weeks. Its data team reviews the trial's data on a clinical trial data platform. At the end, its statisticians analyse the results following the plan drawn up with clinical trial design software, and its medical writers prepare the report.
The sponsor still carries the legal responsibility for the trial. The CRO does the work under a contract, and the sponsor checks its work. Paying an outside company to run a whole function in this way is close to what other industries call a managed service.
India has a large share of the world's CRO work. Global CROs and drug companies run large centres in Bengaluru, Hyderabad, Mumbai and Pune. Teams there do data management, statistics, drug safety reporting and medical writing for trials run all over the world.
A CRO's main cost is people. So some CROs now build their own software and AI models, to do the same work with fewer people. This is described in AI in clinical research operations.