Much of the common advice related to outsourcing of clinical research focuses on the obvious issues — the relative cost of performing research internally versus turning all or part of it over to a CRO, the impact of internal time and resource constraints on time-to-market, the relative experience of the CRO versus the CRO-hiring organization within the target country, and the strategic importance of the research. And while obvious, these are, in fact, important issues that are central to the in-house versus outsource decision.

But there are others that are not so obvious, yet no less critical. An objective evaluation of the costs and risks associated with using a CRO should include consideration of questions like…