Contract research organisations (CROs) provide fast study start up times, quality data that meets regulatory requirements and access to large testing populations that helps pharmaceutical firms (or sponsors) to reduce the costs and the time that it takes to development an asset. All of which are important factors in a competitive industry.
Work can be outsourced on a project by project basis or a sponsor may elect to sign a contract with a CRO through which certain dedicated members of staff with particular expertise are allocated to their projects. A CRO doesn’t carry out its own research and development in order to get a compound approved, the ultimate responsibility is always with the sponsor.
In animal or in vivo studies, CROs will mainly be used in a toxicology capacity, working to Good Laboratory Practice (GLP) benchmarks. CROs have developed to take on research and development (R&D) of a compound at various stages of the process.
Pharmaceutical companies outsource because they have a temporary lack of capacity or resources, or if they realise it would be cheaper to use external resource rather than develop it in-house. There is large growth in the use of CRO for animal-based research and that growth shows no signs of slowing down. Explanation for the growth comes down to the simple fact that CROs can significantly increase the productivity of a pharmaceutical company at a time when drug development firms are under an enormous amount of pressure to identify more compounds leads and get assets to market more quickly than ever.
The benefits of using a CRO
Start-up delays are the first headache that 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 to date with the latest regulatory requirements for approval submission, although ultimate responsibility lies with the sponsor.
CROs also have a wealth of experience pertaining to certain areas e.g. ensuring technicians and animal rooms are used efficiently and productively
The efficacy of study planning is also increased by referring to a history of optimizing space and labour.
In most cases, CROs will have also developed superior procedures for protocol review e.g. Institutional Animal Care and Use Committee [IACUC]