By Bruce Rehlaender, Ph.D., principal of formulation development, PharmaDirections
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.
Perception: Once you sign the dotted line, the project is in the CRO’s court.
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.
Perception: The more money your project is worth, the better service you will get.
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 million 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 perspectives. It also requires strong people skills and an appreciation for the fact that these people are usually overworked and are usually doing their best.
Perception: Quality systems are a given.
GMP systems and levels of quality assurance are among the factors that vary most from one CRO to another. Many smaller CROs do not offer GMP services, while some larger ones cannot function except at the highest level of QA review and GMP adherence. At many CROs, the level of quality assurance can be tailored to meet the needs of the customer.
When contracting a CRO, it is critical to clearly delineate the quality level expected. Be prepared not only to pay more for better quality systems but to wait considerably longer for your data. As a sponsor, you have ultimate responsibility for quality, and you must stay involved both to assure the right quality level and to keep your data moving through the quality system.
Perception: The more a CRO can do, the better.
The appeal of the one-stop-shop CRO is undeniable. After all, who wants to keep up with multiple contracts and deal with technology transfers? Despite what your sales rep will tell you, the reality is that each CRO has its strengths and each has its weaknesses. The shop that is second to none analytically may be clueless when it comes to addressing your formulation problem.
The big CROs with the widest range of services tend also to be the most cumbersome. We can sometimes get well into a project at a small, agile shop before we even get a quote out of their one-stop competitor. So, although life always looks easier at the Walmarts and Targets of contract research, using smaller, more specialized shops may be well worth the extra effort.
Perception: That really smart Ph.D. I met at the site visit will take care of me.
All CROs understand the importance of solid credentials in attracting business, which is why you will always meet the best and the brightest when you are still shopping around. Unfortunately, you will not always get the same expert attention once your project is in the door.
Most CROs hire top-of-the-line scientists to fill their upper echelons, but we often see large scientific and experience gaps between that top layer and the scientists who are directly overseeing projects. Even if you get an exceptionally able project leader, they may be saddled with too many other projects and duties to put adequate scientific energy into your challenges.