For many companies, particularly the smaller ones engaged in clinical trials, outsourcing might not be so much a choice, but a necessity. As we know, clinical trials can be often very complex projects and it isn’t often feasible to conduct the whole process in-house, nor does it make sense from a financial perspective. Thus, it is critical to choose the right CRO. From my experience, it is important to choose partners that are not only capable of doing the work, but can work well as a team. The team responsible for evaluating and selecting (or “qualifying”) the CRO should be composed of team members with wide range of expertise and typically they would visit the facility as well as hold meetings with various levels of staff (management, scientist, QA, etc). It is very important to do due diligence and establish a predetermined set of criteria against which the service provider will be judged. The criteria would range from location, areas of capability, regulatory and compliance and the organizational and operational areas to be evaluated. Typically three CROs are evaluated and the best that meets predetermined criteria is selected.