The aging of the population, high prevalence of chronic diseases, and increased need for evidence‐based practice are factors that have boosted a high demand for clinical trials in the United States. In recent years, an increasing number of clinical trials have shifted from academic medical centers, to community‐based practices, to global sites in different countries. Contract research organizations (CROs) are service organizations that provide research and support services to pharmaceutical, biotechnological, and health companies. This paper aims to explore the evolution of the CRO industry in the United States and worldwide, and to discuss the benefits and pitfalls of the globalization of CROs.
The organizational ecology framework is used to analyze the lifecycle of CROs in response to their environment including their emergence, growth, and evolution to date.
The authors discuss the drug development process, the role of CROs and outsourcing in clinical research. Pharmaceutical companies began outsourcing research activities to increase their profit margins and better position themselves in the rapidly‐changing healthcare environment. The paper analyzes the evolution of the CROs over time and the factor that affected it, including the current globalization stage with special emphasis in India, China and Central and Eastern Europe. Consequences of globalization include the stimulation of research collaboration, policy and issues related to quality.
The evolution of CROs over time points to transformation/evolution of these organizations, with challenges as they become an integral part of the drug development process in the USA and other countries.
