Share thisContract Research Organizations (CROs) are companies with a base business of providing clients (known as Sponsors) with research services on a project or contractual basis.
In the world of outsourcing, CROs are dedicated to providing their clients with fast study startup times and quality data that meets all applicable regulatory guidelines. A large pharmaceutical company may elect to outsource pre-clinical safety assessment (oxicology) work and have a CRO perform the studies on a project-by-project basis. On the other hand, a small, start-up biotechnology company without life sciences and analytical resources may sign a contract with a CRO whereby they are allocated dedicated scientists and technicians who are able to routinely initiate projects with minimal notice. CROs do not participate in their own R&D research for the purposes of drug or medical device approval.
While this article is focusing exclusively on CROs that perform animal, or in vivo, studies, there are CROs who specialize in human clinical trials as well as program management and consulting work. CROs performing animal work are typically geared towards toxicology studies following Good Laboratory Practice (GLP) guidelines. The data from these studies are bundled with other information in formal applications for drug or medical device approval that are submitted to the Food and Drug Administration (FDA) in the United States or foreign regulatory agencies if the Sponsor is seeking product approval abroad. However, an emerging trend for both Sponsors and CROs is the outsourcing of R&D or discovery research.1 Many CROs are now able to handle a wide variety of study types spanning the drug and medical device development life cycle.
Benefits of Using CROs
Sponsors outsource because they temporarily lack resources, do not and never intend to have capacity, wish to focus on core competencies, or are following management mandates.2 The use of CROs in animal-based research has grown tremendously over the past few years, and that growth is poised to continue. The reason for CRO growth is simple; CROs offer multiple advantages to companies and institutions willing to outsource some or all of their animal-based research, advantages that lead to increased productivity to Sponsor organizations. These include the ability to quickly initiate studies as well as provide specialized scientific and regulatory expertise. CROs rely on efficient and expert resource management to ensure that animal rooms and technicians are utilized wisely and in the most productive manner. This means that when a study needs to be started, they can quickly plan for the space and labor needs and can allocate those resources efficiently. In many cases, CROs have also developed expeditious procedures for protocol review (Quality Assurance Unit [QAU], Institutional Animal Care and Use Committee [IACUC], and Institutional Biosafety Committee [IBC] or Health & Safety review). CROs have comprehensive processes and procedures in place for animal acclimation, dosing, animal observations, data recording, pathology, and report writing.