Contract Research Organizations (CROs) provide fast study start times, quality data that meet regulatory requirements, and access to large test populations that help pharmaceutical companies (or sponsors) reduce cost and time it takes to develop an asset. All of which are important factors in a competitive industry.
Work may be outsourced on a project-by-project basis, or a sponsor may choose to contract with a CRO whereby certain dedicated staff members with particular expertise are assigned to their projects. A CRO does not do its own research and development to get a compound approved, the ultimate responsibility always rests with the sponsor.
In animal or in vivo studies, CROs will be used primarily in a toxicology capacity, working with Good Laboratory Practice (GLP) benchmarks. CROs have been developed to take on the research and development (R&D) of a compound at various stages of the process.
Why outsource?
Pharmaceutical companies outsource because they have a temporary lack of capacity or resources, or if they realize it would be cheaper to use external resources rather than develop them in-house. There is tremendous growth in the use of CRO for animal-based research and that growth shows no signs of slowing down. The explanation for the growth boils down to the simple fact that CROs can significantly increase the productivity of a pharmaceutical company at a time when drug development companies are under enormous pressure to identify more leading compounds and market assets faster than never.
The benefits of using a CRO
Startup delays are the number one headache pharmaceutical companies face, and CROs are specialized in getting studies up and running quickly. Using one can greatly reduce the overall study completion time.
Good CROs are also specialized in keeping up with the latest regulatory requirements for approval submission, although the ultimate responsibility lies with the sponsor.
CROs also have a wealth of experience in certain areas, for example, ensuring that technicians and animal rooms are used efficiently and productively.
The effectiveness of studio planning is also increased by referring to a track record of optimizing space and labor.
In most cases, CROs will also have developed superior procedures for protocol review, for example, the Institutional Animal Care and Use Committee. [IACUC]
Directly relevant to animal-based research, CROs will also have developed detailed processes for animal dosing, observation, acclimatization, data recording, and reporting.
