Experiences with Contract Research Organizations

Over a period of 10 years, Schering has worked with at least 15 contract research organizations (CROs), including everything from IRB review to Phase III long-term safety studies. Perhaps 90% to 95 % of the studies have been “short-term” protocols, ie, Phase I, biopharmaceutical/bioequivalence, dermal irritation or sensitivity studies, etc. These have been the most successful. This article outlines some of the advantages-disadvantages of doing different types of studies and gives some recommendations for increasing the chances of a successful venture for both parties.