What is CRO?
Contract Research Organization (CRO) is an organization that provides services to the sponsor or sponsor-investigator.
From FDA 21 CFR 312.3 under Definitions and Interpretations: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.3
Contract research organization means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration.
CROs can perform all the work involved in clinical trial, from pre-clinical R&D studies through all phases (Phase I to IV) of clinical trial. Some examples of services include:
- Protocol development
- Clinical trial management
- Site monitoring
- Quality assurance
- Data analysis
- Medical writing
- Regulatory filings and liaison
Services are done through contractual agreement called Transfer of Obligations. Although the services are outsourced, the sponsor is still the responsible party and need to oversee the quality of the work done by the CRO.
Benefits and Risks in Using a CRO
Potential benefits of outsourcing to CROs include:
- Reduction of time and resources needed to develop new product.
- Lower initial investment and on-going costs in hiring personnel, equipment, and facilities needed.
- Expand greater access to expertise.
- Get access to standardized process of clinical trial conduct.
Potential risks of outsourcing to CROs include:
- Reduced control in direct management of clinical trial conduct
- Potential cost overrun due to unexpected delays
- Consistency from project to project may vary depending on personnel turnover at CROs
Growing Trend in Outsourcing Work to CROs
Some of the largest CROs include Quintiles, Parexel, Covance, Pharmaceutical Product Development (PPD), Icon Clinical, INC Research, inVentiv Health Clinical, Charles River Laboratories (CRL), etc.
As clinical trial are conducted more and more globally, the industry trend is heading toward the outsourcing model where sponsors are outsourcing more and more of the work out to CROs. Large CROs with global reach are dominating the market with full service offering. Yet there is room to grow for smaller CROs in different regions of the world. The trend for outsourcing of clinical trial related work remains strong for the foreseeable future.
Wondering what it’s like to work as a CRA at a CRO? Click here to read more.
- Clinical Trial Site
- Institutional Review Board (IRB) or Ethics Review Committee (ERC)
- Regulatory Body
- Site Management Organization (SMO)