CRO worries grow as research business booms

By one estimate, CROs will see their contract research operations swell from $7 billion in 2006 to $19 billion in 2013 as more and more biotech companies turn to them to manage drug trials. But as the work of the CROs grows, so do concerns over the quality of the research work they manage. A number of experts tell the San Jose Mercury News that the CROs are working without any kind of significant government oversight. Arthur Caplan, a University of Pennsylvania bioethicist, tells the paper that a CRO-related disaster is just a matter of time. Aside from noting problems in clinical trials mounted for two Bay Area biotechs, though, there's little actual evidence presented of a problem. And with one out of every five R&D dollars going to an "outside expert," there has been plenty of opportunity.

Regardless of the ominous warnings, though, CROs are positioned to enjoy a major increase in business as developers of every stripe turn to outsourcing at least part of their R&D work.

"If you want to do that all by yourself, you need an unbelievable infrastructure that we've never had," says Norbert Bischofberger, Gilead's chief scientific officer. "It's just too expensive."

- read the story in the San Jose Mercury News