Outsourcing

Contract research organizations (CROs) play a vital role in the development and safety testing of drugs, biologics (e.g. vaccines), and medical devices.

While CROs are not developing these products themselves, other companies (the "sponsors") contract specific development and safety studies to be performed at CROs.

The choice of which development and safety studies to undertake is not made by whimsy. In order to gain approval for marketing a new drug, biologic, or device, the sponsor must gain approval from the Food and Drug Administration (FDA). Studies contracted to CROs are usually conducted to support various stages of a product's approval with the FDA. For drugs in particular, the whole process of bringing a new drug to market is often termed the "drug development life cycle." While there are parallels to the drug development life cycle, the approval process for biologics and medical devices is different. For the purposes of this article and our on-going examination of CROs, however, we will focus on the drug development life cycle.

Food and Drug Administration
In 1938, landmark legislation known as the "Food, Drug, and Cosmetics Act," also known as the FD&C Act, was passed and became law. While other legislation focusing on the safety of vaccines and the misbranding of food and drugs, such as the Biologies Control Act of 1902 and Food and Drugs Act of 1906, pre-dates the FD&C, it was the FD&C Act that established the requirement that new drugs be proven safe before they can be marketed to the public.¹ The FDA has its roots in the United Stats Department of Agriculture's (USDA's) Bureau of Chemistry, which became a standalone entity in 1901, and has grown to become a large government agency with thousands of employees.² It enforces the FD&C Act along with other health-related laws, thereby regulating the approval of drugs, medical devices, veterinary drugs, animal food additives, biologics for human use, and other products. Drug development scientists, drug/biotechnology companies, regulatory affairs professionals, toxicologists, and laboratory animal staff follow FDA actions, new legislation, and new regulations closely to see what activities and requirements will impact the conduct of drug development/safety studies and ultimately the approval of such drugs.

From 1993 to 2006, the FDA averaged just over 115 New Drug Applications (NDAs) a year.³ Eighty-eight new drugs per year, on average, were approved by the FDA for that same time period.³ The time to review a new drug application can range anywhere from six months for drugs receiving certain special statuses, to over a year.³ By the time an NDA is submitted to the FDA, after the completion of human clinical trials, many years of research and hundreds of millions of dollars have been expended to prove that the drug is safe and will work.^4,6 This work is usually divided up into pre-clinical and clinical phases. Pre-clinical work generally refers to work done in animals to investigate the drug's attributes and safety while clinical work generally refers to studies in humans.