Clinical research organizations (CROs) are businesses that conduct drug testing and development for pharmaceutical companies. Some companies have an in-house CRO, while others outsource to independent organizations. CROs can help with FDA approval and save companies money, but concerns exist about outsourcing to questionable facilities and the impact on job security.
A clinical research organization (CRO), also called a contract research organization, is a business that works in the pharmaceutical industry in most cases. The clinical research organization may be involved in all new drug development processes. Others just administer tests on newly developed drugs.
Some large drug companies have a clinical research organization within the company. Others prefer to outsource drug testing and development to other organizations specifically designed for this purpose. By hiring an independent clinical research organization to administer the tests, the test results are less questioned, since the independent organization has no interest in promoting a bad drug. As some drugs, which have been tested by their manufacturers, have been shown not to do what they promise, the independent clinical research organization has proven to be invaluable to pharmaceutical companies.
In addition to clinical trials on a variety of pharmaceuticals and different chemicals, a US clinical research organization can pave the way for successful Food and Drug Administration (FDA) approval of chemicals. FDA requirements are significant, and the accumulation of a large amount of positive data on a chemical helps move the drug quickly into the approved category. The clinical research organization can help prepare all FDA filings and supporting documents needed to obtain approval.
There is some concern about where and when new chemicals and drugs are outsourced to a clinical research organization. These concerns may be purely from an economic point of view. For example, outsourcing to a clinical research organization outside your country can mean fewer jobs for scientists in one country.
Some people also express concern about outsourcing to facilities where the purity of the research is questionable. There are numerous new clinical trials underway in third world countries. While these findings must be duplicated in most cases in the United States before a drug gets FDA approval, questions still arise about the methods employed and occasionally about the lack of resources at a clinical research organization. That’s not to say there aren’t plenty of great CROs in many different parts of the world.
Outsourcing 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 only have to pay a clinical research organization for the time it takes to test a chemical. This means they don’t have to hire and then fire people after all the research on a drug has been done. It reduces the stress on the HR department of the company and can add more job security to the employees of a company.
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