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Revision as of 07:56, 17 March 2025
Contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets. They aim to simplify entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant.
History
The concept of a contract research organization began in the early 1980s. The first CROs were small, specialized firms designed to provide niche services to pharmaceutical companies. Over time, CROs have grown and expanded their services to include all phases of drug development, from preclinical research to post-market surveillance.
Services
CROs offer a variety of services to the pharmaceutical, biotechnology, and medical device industries. These services can range from early stage discovery and development to post-market surveillance. Some of the key services provided by CROs include:
- Biopharmaceutical development
- Biologic assay development
- Commercialization
- Preclinical research
- Clinical research
- Clinical trials management
- Pharmacovigilance
Benefits
The main benefits of using a CRO include cost savings, access to specialized expertise, and the ability to focus on core competencies. By outsourcing research activities, companies can reduce their fixed costs and increase their flexibility. Additionally, CROs often have specialized knowledge and experience that can help to accelerate the drug development process.
Challenges
Despite the benefits, there are also challenges associated with using a CRO. These include potential issues with quality control, communication, and coordination. It is important for companies to carefully select and manage their CRO partners to ensure that they receive the best possible service.
