Contract Research Organization (CRO)

What is CRO?

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.

CRO Services

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.

Type of CRA

In-House CRAs

CRAs who work for a sponsor company are called in-house CRAs. An in-house CRA may be overseeing all aspect of clinical trial conduct, from planning to clinical study report (CSR) generation for submission to regulatory bodies. Below are some job functions of an in-house CRA.

• Designs study documents such as, study designs, synopsis, site specific protocols, informed consent forms, case report forms, site study procedure manuals and project tools, monitoring plans, and tracking tools, clinical study reports, budget and contract negotiation.
• Performs independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits.
• Maintain frequent contact with and work effectively with investigators and coordinators.
• Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.
• Review and resolve discrepancies in clinical data with clinical sites or through a contract research organization (CRO).
• Low amount of travel may be required (e.g. up to 25-30%).

Regional CRAs / Home-based CRAs

CRAs who work independently from home are called regional CRAs or home-based CRAs. Regional or home-based usually don’t handle planning and preparation of clinical trials. They generally handle the monitoring function and oversee trial conduct. Thus, they can work from home and they usually travel quite a bit more than their in-house CRA colleagues.

• Performs independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits.
• Maintain frequent contact with and work effectively with investigators and coordinators.
• Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.
• Review and resolve discrepancies in clinical data with clinical sites.
• High amount of travel may be required (e.g. up to 75-80%).

CRAs Who Work For a CRO

CRAs who work for a contract research organization (CRO) can be either in-house CRA or monitoring CRA. They usually work out of a CRO’s office. As the goal of the CRO is to provide full range clinical trial services to sponsor companies, CRAs who work for a CRO may be called upon to perform in-house or monitoring functions depending on the project and client’s needs. One note to mention is that CRO is sensitive to the economic cycles. When the economy is good, CROs may hire a lot of CRAs to meet the higher numbers of clinical trial demands. When the economy is bad, CROs may turn around and lay off CRAs as work demand reduces. In addition, CRAs who work for a CRO are expected to work hard. They may be assigned to oversee multiple studies with high number of sites (>10 sites). That being said, a CRA position at a CRO is usually a good way for a new CRA to gain experience. Another benefit in working at a CRO is getting exposure to a variety of therapeutic areas that may enhance a CRA’s credential and career progression.