How Do Contract Research Organizations Function

CROs are involved in all drug or device production stages, from discovery to launch, but they specialize in Phase I–III clinical trials.

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A Contract Research Organization (CRO) is an independent contractor hired by a funding corporation to conduct clinical trials and provide other research support services on its behalf. CROs primarily work with pharmaceutical, biotechnology, and medical device firms, but they also work with governmental organizations, foundations, and universities. These companies hire CROs to get the specialized knowledge they need to conduct trials safely and effectively without having to hire permanent staff.

How Contract Research Organizations Work

Pharmaceutical companies are gradually outsourcing vital functions such as production and testing due to the difficulty of drug and device creation and the need to bring drugs to market quickly to beat the competition and meet patient needs. As a result, there has been a surge in the recruiting of CROs.

CROs are involved in all drug or device production stages, from discovery to launch, but they specialize in Phase I–III clinical trials. 

Trials necessitate a slew of complicated tasks, from protocol creation to content planning for submission to the Food and Drug Administration (FDA).Trial sponsors, such as pharmaceutical firms, can outsource these tasks to a CRO by officially assigning their obligations to the CRO in writing, rather than hiring permanent staff with the advanced skills required to execute these tasks in-house. As an independent contractor with advanced expertise, the CRO may help the sponsor bring new products or devices to market quicker, more effectively, and at a lower cost by performing various tasks on their behalf.

The CRO's services vary; a few include:

• Biological and chemistry expertise.


• Formulation assistance.


• Database design and build.


• Project management.


• Validation and data entry.


• Clinical trial patient recruitment.

Some CROs provide specialized services in one or all of the above fields and for a wide range of medical industry clients. Niche CROs, on the other hand, focus on particular areas or groups of clients. A biometric CRO, for example, might focus on statistical analysis and data processing for medical device companies.