Functions and Types of CROs

Abstract

The entire contract research/development and production industry has evolved into a major industry in its own right. The critical shortage of new drugs in the pipeline has forced a number of major pharmaceutical companies to form strategic partnerships with companies capable of bringing in resources not currently available in their own organizations, especially due to a lack of investment or downsizing. The dearth of new chemical entities and the pricing pressure from the managed care organizations and the state and federal governments has made every pharmaceutical company evaluate the costs of developing a new drug and its commercial manufacturing. Additionally, most new drugs arise from small organizations which have very limited (if any) internal development capabilities. At the same time, the limits of internal resources and increased regulatory requirements for bringing new products to market power the same needs for the medical device industry.