CRO’s, or contract research organizations, are a $40 billion industry, growing at close to 12% per year. They provide contract services to the pharmaceutical industry, including statistical design and analysis, laboratory services, administration of clinical trials, and monitoring of drugs once they are on the market.
Developing a new drug and bringing it to market is an extremely complex process – involving scientific innovation, randomized clinical trials with hundreds or thousands of patients, and the navigation of a daunting regulatory approval process. As a result, it is also very expensive – over $2 billion per approved drug, according to some estimates. CRO’s bring expertise and experience to the process so that a drug development company need not reinvent the wheel for each phase of the process.
Statistical services are a common outside service to seek help with. This is particularly for new companies built around a drug innovation – they may have deep expertise in the science associated with their innovation, but be relative neophytes when it comes to the detailed statistical protocols associated with the different phases of drug testing.
Innovations on the statistical front are more quickly promulgated via CRO than by one drug company learning from another. Cytel Software, a specialist CRO with deep statistical expertise, has been a pioneer in flexible clinical trial planning (e.g. allowing for sample size adjustments, or early termination of trials) that can bring drugs to market sooner and at lower cost. Close communication and collaboration with the U.S. Food and Drug Administration contributed both to the acceptance of flexible clinical trial designs by regulators, and to Cytel’s leading position in this market.