For me, CRO, because CRO is like the “middle man” between the Sponsor and the research sites.
CRO get hired by sponsor, 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. 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. 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.