One third of pharmaceutical clinical trials are outsourced, as referenced in a story in Pharma Times which quoted Kalorama Information's research on this topic.
This probably will not be news to employees of pharmaceutical company R&D departments, facing cost pressures and at the same time, a need to keep up with increasing demands for new products. But outside observers to pharma markets may not be aware that outsourcing is more and more common, and not just on Phase I. Phase III and post-approval phases are a growth area for outsourcing.
Internally from customers and from news media we have received the question: is outsourcing safe? Particularly where an offshore service is involved. Actually although it may appear that non-US trials are not safe for drugs entering the US market, one has to consider that nations such as Russia and India, patients are less exposed to pharmaceuticals in general and thus trial results can be more earnest and less subject to interference either from other drugs taken by the patient or by patient perception. We've also been asked: Is it only to save money? Not always. The outsourcing companies are actually getting better than branded pharmaceutical marketers in some cases at conducting a trial. Even where it's hard to measure comparative talent, there's no dispute that CROs and AMCs can handle more volume.
Kalorama's report on this topic contains more information on the the market size for contract research in clinical trials, what entities are conducting trials and what regions trials are being held.
