Jeremy Minshull, Ph.D., CEO of DNA 2.0, compresses this continuum of service levels into a simple dichotomy.
“At one extreme, a CRO is more like the CMO. Instead of carrying out research, they’re really doing more manufacturing,” he explains. In that model, the CRO simply does exactly what the client tells them to do. That is a relatively low-value proposition for the CRO. And I think it’s less valuable for the clients because there is a sort of gap between data generation and data analysis.”
Dr. Minshull maintains that it’s critical to have people who know what they’re doing actually conducting the experiment. “Sometimes there will be things that may not seem important at first but are actually vital to the execution of the experiment,” he points out. “Unless you’re reasonably experienced you won’t necessarily know that.”
At the other end, continues Dr. Minshull, is where the CRO does all the thinking. “The client gives specifications, and the CRO provides them with exactly the functionality that they’ve asked for. This tends to be very expensive.”
Part of that cost is driven by the fact that the CRO is redeveloping capabilities that the client already possesses, he explains.
“DNA 2.0 takes the middle ground. We apply our expertise, and we know how to evaluate scientific experiments,” he says. “But we don’t want to replicate capabilities. We are more likely to succeed than the simple ‘follow my instructions’ model.”
Different CROs also can come in a variety of sizes, some filling small but crucial niches with a workforce of 10–20 employees and others operating with thousands of workers. What are the advantages and disadvantages of small versus large CROs?
“In general, small CROs are more willing and able to change with the market and can develop new technologies more rapidly,” claims Jack Vanden Heuvel, Ph.D., CSO of Indigo Biosciences. “However, large CROs have the distinct advantage of being able to offer an integrated set of services and products. This soup-to-nuts CRO is more likely to garner the larger projects as the biotech company can have the majority of its research performed with one provider.”
Dr. Vanden Heuvel’s sentiment is echoed by Florent Hediard, life science services marketing director at SGS Vitrology.
“Working with a small CRO has the advantage of having a real expert available with a dedicated and supportive team during the process at an affordable cost, but with a very limited service offer and geographic scope,” notes Hediard.
“A large CRO can bring the full-package service offer and the financial investment in its own infrastructure to support the operation under contract.”
Overall, companies looking to outsource work can find a variety of service levels and expectations. Certain CROs are willing to perform the majority of the footwork on experimentation, while others are more apt to provide technical assistance and expertise with respect to moving through regulatory challenges.
The key aspect, as told by almost every interviewed CRO, is to build relationships and trust on both ends of the contract to assure the highest-quality work.