Contract research organizations method transfer

The globalization of pharmaceutical companies means that, within the same company, the same assay may be carried out at different sites, within the same country or in a different continent. Under these circumstances, it needs to be assured that the assay transferred to each of these sites continues to perform as originally developed and validated. In addition to within-company transfers, there is an increasing tendency to outsource methods to contract research organizations (CROs). The method is usually developed within the innovator company and subsequently transferred to the CRO. The reasons for using CROs vary with the philosophy of the company. 

Successful method transfer requires a good match of skills, experience, and team dynamics between the sending and receiving laboratories. If contract research organizations are involved, the initial selection step of a suitable contractor requires an evaluation of these compatibilities. However, if the transfer occurs within an organization or as part of already existing partnerships, the match between labs may be... 

In addition, outsourcing becomes more and more common to reduce the cost of drug development in the pharmaceutical industry. UHPLC methods developed in a company with UHPLC capability need to be transferred to contract research organizations (CROs), which may not have UHPLC capability. 

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