Perception And Reality At CROs

By Bruce N. Rehlaender, Ph.D., Director, Formulation Development, PharmaDirections, Inc.

It’s hard to avoid CROs these days. From two-person virtual companies to the largest multinationals, everyone is outsourcing, and like everything else, this trend has its pluses and minuses. For those new to the game, we thought we would address some perceptions and realities we have found in working with pharmaceutical CROs.

Every CRO brags about its project management abilities and claims it can take your project and run with it. In reality, this is very seldom the case. Without attention from outside, slippage of timelines and scientific misunderstandings tend to be the rule rather than the exception. CRO scientists and project managers are usually doing their best, but they have a lot of other things going on and may not understand your project as well as you thought they did.

Bigger money unquestionably generates more attention from the commission incentivized BD folks. You may never hear back about a $5,000 project, while a $5,000,000 request for proposal may earn you daily foot massages. Once the project makes it into the lab, however, you are dealing with salaried scientists who are primarily motivated by two things: desire to do a good job and nagging. Getting speed and quality out of the lab requires excellent oversight, both from the scientific and from the project management perspective. It also requires strong people skills and an appreciation for the fact that these guys are usually overworked and are usually doing their best.