A Contract Research Organization (CRO) is an important player in the development of new products for biopharmaceutical companies. CROs provide broad support to the pharmaceutical industry with pre-clinical to post-marketing activities. This can include anything from market surveillance all the way up through management of Phase III trials and approval processes, if applicable. Sometimes confused with Clinical Research Organizations or Clinical Research Companies, CROs provide a wider range of services to the companies they support.
What is a Contract Research Organization?
Located the world over, a Contract Research Organization (CRO) is an independent contractor with a sponsor who designs, selects, and evaluates the research materials that need to be submitted for approval to the Federal Drug Administration (FDA) or other government regulated authorities. CROs can help reduce costs for companies developing new drugs and medicines by performing targeted market research. In some cases, they aim specifically at reducing time spent on entry-level markets – where competition can be fierce, but also profitable. By outsourcing this demanding work, CROs free up time for pharmaceutical companies to focus on their own research and design work and continue to innovate—a key to success in such a demanding and ever-changing industry.
An example of work that CROs complete includes management of clinical trials and study support, ranging from small, niche groups to large international corporations with highly specialized technologies. This includes, for example, academic institutions that need routine histology processing before use by clients.
What to Consider When Looking For a CRO
A Contract Research Organization is a reliable partner for any company’s scientific or regulatory needs. They typically offer contracts that combine the core business of toxicological pathology with other services such as histology, image analysis, microscopy technologies, and histotechnology, to name a few.
When considering employing the services of a CRO, there are a number of factors that organizations must weigh. They range from the basic alignment of services provided with services needed, to deeper considerations of values and overall innovation. Factors to consider include:
- Application of medical and scientific knowledge
- Collaboration with other professionals and businesses
- Conduction of physical assessments
- Focus of expertise
- Handling multiple tasks simultaneously
- Innovation in thinking
- Laboratory values
- Patient interaction
- Problem-solving abilities
- State-of-the-art infrastructure
Services Offered by Contract Research Organizations
Contract research organizations maintain teams that can provide a wide range of comprehensive services according to the needs of the companies they support. These services may include:
- Collaboration with other businesses/professionals
- Data entry and validation
- Presentations
- Professional training and education
- Project management
- Publications
- Quality assurance certification
- Reporting of metrics
- Safety Alliance
- Statistical analysis reports and plans
A well-functioning support team can assist pharmaceutical companies and other organizations by providing services such as monitoring safety profiles/adverse events data from various sources, coordinating international regulatory submissions, and managing manufacturing capacity planning, including scaling options according to different scenarios.
The wide array of services that CROs provide and their worldwide accessibility make them an important contributor in the pharmaceutical industry.