By Kevin Davies
February 17, 2009 | The bitter weather that has been enveloping the north east won’t have bothered Andrew MacGarvey, the newly installed president of Quanticate’s American office in Cambridge, Mass. MacGarvey moved from the U.K., which has been paralyzed by a mere few inches of snow.
Quanticate was formed 18 monthss ago from the merger of two 15-year-old European biometric CROs—Oxford Pharmaceutical Sciences and Statwood. “The heritage is really statistics and programming,” says MacGarvey. The firm is a biometric CRO, with more than 200 personnel. “We are a niche specialist provider, but we have very large critical mass,” he says. His new mission is to expand Quanticate’s clinical trial service capabilities in North America, while continuing to manage global sales. “The move to establishing a U.S. headquarters is in response to the terrific reception of our products by companies here in the States,” says MacGarvey.
The firm has two major groups of customers. One group seeks Quanticate’s expertise with statistics, study design, programming expertise, and data management, which is married with a clinical partner. Quanticate is also picking up FSP (functional service provision) work for customers, providing up to 40 heads on a specific project, whether it be programming, statistics, or medical writing.
The company has offices in the U.K., Poland, and South Africa. The U.S. office began as a sales office, but MacGarvey’s charge is to build up U.S. operations, leading a small team that currently has three business development staff and a handful of programming talent. “I’ve come over to expand the operational capability,” he says. “We’ve already got U.S. customers working with us, but some of our U.S. customers were saying you need to have more operational people over here…. We’ve decided to take this as seriously as it needs to be taken.”
Quanticate’s best known clients include top-five pharma companies, but MacGarvey has his eye on mid-size companies and biotechs. “We want to keep a variety of work for our workforce, keep the retention rates high,” he says candidly. “If you restrict yourself to larger customers, the work can be a little repetitive. Also, from a strategic point of view, it helps to have these emerging companies and building relationships with them earlier. We hope to grow with them.”
Quanticate provides services in clinical data management, programming, statistics, and medical writing. It currently partners with clinical companies chosen based on the therapeutic area or regional considerations. But he wants to bring clinical services on board and become full service. Among the companies that MacGarvey comes up against are i3, ICON, and Kendall.
Virtual Reality
A lot of emerging prospective clients are almost virtual, MacGarvey observes. “They’re getting funding to get these studies kicked off, but they tend to have very few operational people.” Quanticate takes a very consultative approach to business development, he says. “We don’t go in with a slide deck necessarily. We’ll go in and have a conversation, talk to the person. They want to know right down to the study design what our advice would be, and which vendors to work with to help put the study together.”
MacGarvey’s been advising “a local company” about their data strategy, trial management systems, and EDC, to help them formulate a data strategy. “The larger companies tend to have more bodies on the ground… but they’ll be interested in talking to us about European [trials]… If they’re going to submit across the Atlantic, they’ll want to talk about expediting European submissions.”
Quanticate works with Phase I onwards. Typically, the client will have preclinical data. “Sometimes they’ll have Phase I studies run already, and we’ll come in to look at the Phase II trials. Because we are biometrics … we’re being used by lots of different groups.”
Easy EDC
Quanticate offers its own SAS-based EDC system called ClinNav, but MacGarvey says recommendations are determined by the needs of the customer. “The ClinNav system is very simple to use, without lots of bells and whistles… You capture the data, you can clean the data.” When one client wanted to launch a quick trail at various sites around the world, MacGarvey’s advice was: “Look, you’re going to want something that’s been used in a lot of the sites already, because you’re trying to go so quickly. So you’re probably better off using something like the Phase Forward product.” As simple as ClinNav might be, it still requires site training, which takes time. The company works with Oracle as well.
MacGarvey said his team is seeing “a great deal of take-up” in adaptive trials. “It’s becoming a very hot topic back in Europe, and I guess it’s the same here.” Quanticate’s statistical heritage presumably helps in that regard.
MacGarvey says Quanticate has been re-evaluating its strategic plan, but “we haven’t seen any sort of downturn in the number of studies coming through. That may be serendipity, I don’t know. It’s becoming more competitive. Off-shoring is picking up. I’ve definitely seen this commoditization of some of the tasks in the biometrics area.” A more pressing concern is the biotech funding, which MacGarvey reckons will affect the pipeline. “That issue will hit us in a couple of years,” he warns.
“We’re seeing a lot more interest in protocol design. When you throw EDC into the mix, you’re getting very accurate data.” Growth, he says, will be bolstered by FDA pressures on trial sponsors to provide more in-depth and complex data. “The market grew by 15% last year and this growth looks set to continue,” he says. “With our ability to deliver services across three continents and our flexibility to adapt to any technology environment, I believe that Quanticate is in a very positive competitive position.”