What is a Clinical Research Organization?

A clinical research organization (CRO), also called a contract research organization is a company that works in the pharmaceutical industry in most cases. The clinical research organization may be involved in all processes of developing new pharmaceuticals. Others merely administer tests on newly developed drugs.

Some large drug manufacturing companies have a clinical research organization within the company. Others prefer to outsource testing and drug development to other organizations specifically designed for this purpose. By hiring an independent clinical research organization to administer testing, results of testing are less questioned, since the independent organization has no self-interest in promoting a bad drug. Increasingly as some medications, which were tested by their makers, have proven not to do what they promise, the independent clinical research organization has been shown to be invaluable to pharmaceutical companies.

In addition to clinical trials on a variety of pharmaceuticals and different chemicals, a US clinical research organization may prepare the way for successful chemicals to be approved by the Food and Drug Administration (FDA). FDA requirements are significant, and amassing a large amount of positive data about a chemical helps to quickly move the drug into the approved category. The clinical research organization may help prepare all FDA paperwork and supporting documents needed to gain approval.

Some concern exists about where and when new chemicals and drugs are outsourced to a clinical research organization. These concerns may be purely from an economic standpoint. For instance, outsourcing to a clinical research organization outside of one’s own country can mean fewer jobs for scientists in a country.

Some people also express concern about outsourcing to facilities where the purity of research is questionable. There are numerous new clinical trials taking place in third world countries. While these results must be duplicated in the US in most cases prior to a drug gaining FDA approval, questions about the methods employed and occasionally lack of resources at a clinical research organization continue to arise. This is not to suggest that there aren’t many fine CROs in many different parts of the world.

Outsourcing of development and research to a clinical research organization tends to save money for chemical and pharmaceutical companies. They don’t have to maintain an “in-house” clinical department, and they only have to pay a clinical research organization for so long as a chemical needs to be tested. This means they don’t have to hire and then fire people after all research is done on a medication. It reduces stress on the human resources department of the company and can add greater job security to the employees of a company.