CAUGHT IN THE MIDDLE: HOW SPONSORS, SITES AND CROS CAN WORK TOGETHER EFFECTIVELY

Pharmaceutical, biotechnology and medical device companies hire contract research organizations (CROs) to assist them in conducting clinical trials. Since the first CROs were founded in the 1970s, they have grown into a $10 billion industry with over 130,000 employees.1,2 There are many specialized CROs, but the bread-and-butter functions of most CROs are recruiting and monitoring investigative sites. Only 29% of U.S. sites rate their CROs as excellent, so 71 % have at least some complaints.3 46 % say the involvement of a CRO makes studies less profitable. 4 Despite being considered by many sponsors and sites as a necessary evil, CROs play a role in over 60 % of all clinical studies.5 If all the CROs were to disappear tonight from the face of the earth, any celebration would end before noon tomorrow. Despite their ubiquity, CROs are often misunderstood. Many sponsors and sites do not know how to work with them effectively. Sites and sponsors often blame CROs for problems that are not the CRO’s fault, even problems that the CRO warned them about. When sponsors and sites have an issue, they often first agree to blame the CRO. In fact, “Scapegoating Services ” should be part of every CRO request fo