Frequently Asked Questions
About Contract Research Organizations
What is a CRO?
A CRO is an independent business that performs specified research services for the business' clients. In th pharmaceutical industry, CROs are hired to carry out a broad spectrum of research services, from the preliminary conceptual phases of drug discovery through post-marketing surveillance.
Who hires CRO's?
CRO's are hired by businesses requiring specialized research services. A CRO can often provide the required service at a reduced risk, faster pace, and lower cost than the client business could accomplish using its own internal staff and equipment.
Why might I need a CRO?
You might consider hiring the services of a CRO whenever you are planning a research project requiring staff, skills, or capital resources that are scarce or unavailable within your own organization. For instance, you may need to synthesize drug discovery lead compounds according to a predictable schedule. If your own organization does not have a chemistry services group with deep experience developing synthetic routes, you would seek a CRO with a proven track record in custom synthesis of drug compounds...
What kinds of CRO's are there?
CRO's are best categorized according to the services they can provide directly, or through complementary partnerships with other CRO's. One can make a useful distinction between CRO's that provide pre-clinical research services, such as medicinal chemistry and ADME-Tox testing, and those that provide clinical research services, such as clinical trials management and regulatory submissions.
How much does it cost to hire a CRO?
CRO costs vary according to the types of services provided, the amount of directly relevant experience a CRO can apply to a specific project, and the CRO's internal cost structure. A CRO may be able to cite a full-time equivalent (FTE) rate, which is the fee the CRO would charge to assign full-time staff to a specific project. While the FTE rate can be helpful when making initial cost estimates, a detailed project proposal from the CRO is required for more accurate cost visibility.
How does a CRO help manage risk?
A CRO can help manage project risk in two ways: first, a CRO can provide specialist knowledge and experience that is specifically relevant to the project, increasing the likelihood of project success. Second, a CRO with such specific experience may offer a risk-sharing agreement that makes part of the CRO's fee contingent upon defined project outcomes. This form of risk sharing effectively reduces the level of financial risk associated with the client's project.