Recently I had a viewer ask me what is the difference between a clinical trial Sponsor and a CRO? They also wanted to know who pays for the research study and whether anyone can contract the CRO for research as long as they can afford it. These questions are simple and short, but they’re important because a lot of people out there get confused by the terminology in this industry.
For starters, a Sponsor is exactly what it sounds like — they sponsor the clinical research study. A Sponsor may or may not choose to use a CRO, which is a clinical research organization or contract research organization. Basically, a CRO is the “middle man” between the Sponsor and the research sites. While there are some Sponsors that don’t use CRO’s and choose to do the monitoring of sites and data themselves, most Sponsors do end up utilizing the services of a CRO. I’d say about 90% of Sponsors use CROs because the Sponsor’s specialty is creating the drug and developing new products as well as better treatments. Their expertise is not necessarily in managing clinical trials and submitting studies to the FDA for review. That’s where a CRO comes in. A CRO helps the Sponsor write the protocol, submit the data to the FDA, and monitor the sites throughout the study. CROs usually also have a medical monitor, which is typically a physician that the research sites can call when they have a question about a particular study participant, or need to request for a waiver to allow a particular study participant to get into the study. Usually if the Sponsor has a CRO they will have the CRO handle all communication with the sites. They will occasionally get involved, but usually they let the CRO do that.
The CROs also hire their own CRAs (clinical research associates) who go out and monitor the sites. CRAs basically go out and make sure the sites are exhibiting good clinical practice (GCP) and are following the protocol.
To summarize, that’s essentially the difference between a Sponsor and a CRO. Who can pay for a CRO? Basically, anybody who has a clinical trial. Typically a lot of biotechs have been using CROs recently because they don’t have much expertise in managing studies or submitting studies to the FDA for review. As such, they need the expertise and the help of a CRO to hopefully bring their product to market.