This post was originally published on Quora, answering the question: "How do drug manufacturers select the right contract research organization(CRO)?"
Selecting the right contract research organization (CRO ) obviously depends on what activity is outsourced and with which regulations the outsourced processes need to comply. However, the following criteria certainly apply to pharma companies.
Typically, we would request evidence on how often the CRO has performed the activity, i.e., what their relevant experience is from a technical operation point of view. However, it is also very important to understand how they deal with Quality Assurance, Training, Disasters, and if they have been inspected by health authorities before, if upon inspection there were any critical findings, and how they managed these findings.