What is a CRO?
A CRO is a contract research organization. It runs research, testing, or clinical trial work for a drug developer under contract. The developer is usually called the sponsor. CROs let a sponsor run studies without building its own laboratories or trial teams.
What CROs do
The work falls into a few broad groups.
- Discovery and preclinical research: chemistry, biology, pharmacology, and the safety studies needed before a drug is first given to people.
- Bioanalysis: measuring a drug, its metabolites, or antibodies against it in blood, plasma, or other samples from studies.
- Clinical trials: choosing and managing trial sites, monitoring, data management, statistics, safety reporting, and regulatory submissions.
- Testing for manufacturing: analytical and release testing of batches made by the sponsor or a CDMO.
Full-service and specialist CROs
A full-service CRO offers most of these services and can run a program end to end. A specialist CRO focuses on one area, such as bioanalysis, toxicology, or a single therapeutic area. Some sponsors use one large partner. Others pick a specialist for each piece of work and manage the handoffs themselves.
Quality rules
Each kind of work has its own quality rules. Good laboratory practice applies to nonclinical safety studies that support a regulatory filing. Good clinical practice applies to trials in people. Good manufacturing practice applies to release testing of medicines. Ask which rules a CRO will follow for your work, and make sure they match what your filing needs.
What stays with you
Good clinical practice lets a sponsor transfer trial duties to a CRO, but the sponsor stays responsible for the quality and integrity of the trial data. The same idea runs through other work: the CRO does the study, and you decide whether its results support your program. A written agreement should say exactly which duties the CRO takes on.
CRO or CDMO
If you need a study run or a sample measured, you want a CRO. If you need material made, you want a CDMO. Use the research lists for the first and the manufacturing lists for the second.