Quanticate is the most established biometrics-oriented contract research organization (CRO) you’ve never heard of. Quanticate is the new name for the marriage of two U.K.-based, heavyweight biostat-centric CROs that merged last year, Statwood and Oxford Pharmaceutical Sciences.

Things have really been moving fast for the new entity. The company announced its first official U.S. presence in July of last year, opening an office in Boston. And now, as of late January 2009, Quanticate has an ebullient new CEO who relocated from Hertfordshire, in the southeast of England, to Boston.

New; Old

He’s Andrew MacGarvey, formerly of PRA International, Datatrial and Omnicare. But he’s not exactly new to Quanticate or its forbears. MacGarvey was hired by Oxford Pharmaceutical Sciences in 2006, soon after it became clear there was going to be a deal with Statwood, a company for which MacGarvey had worked in the past.

MacGarvey says Quanticate is already strong in Europe, dominating the biostats and data management segments of the market even when drug makers can choose large firms like Kendle or Parexel. Coming to the U.S. quickly was a crucial piece of the strategy, MacGarvey says. So is close attention to customer service. “The next battleground is customer service,” he says. “You have got to be face to face.”

Clinical Purchase?

His U.S. location will facilitate that. “When it comes to global trials, a lot of the decisions were being made by companies in the United States,” MacGarvey says. “We were finding that we needed to be here.” The plan, then, is to acquire rather than to do a lot of hiring. Quanticate is seeking a traditional clinical component. Yes, Quanticate is all about biostatistics, and that has worked well for them. But MacGarvey says the company is realizing it needs to expand its offerings to compete.

“We’re finding that about 50 percent of the people we talk to have a policy that they need to go with a full-service provider. If you’re not full service, you don’t get invited in to discuss your services,” MacGarvey says, adding that he understands the logic. “If you are outsourcing, you try to reduce the number of contracts and providers.”

MacGarvey says he and his team have made their “long list” of potential targets and are likely to acquire one, maybe two, clinical services-focused CROs on the East Coast without much additional delay.

Cultural Fit

“The feeling is to go East Coast purely for communications with Europe,” he says. “For me, the feel of the company will be very important. Cultural fit. What people like about us is our very personal approach, the sense every customer gets that they are very, very important to us, and that we take data very seriously.”

When asked to name direct competitors, MacGarvey ponders it for a bit, then says, “i3 Research ... and the Kendles of this world. We don’t come across other biometrics-only CROs. We bid against the bigger players.”

Molecule Explosion

Currently, Quanticate’s operations break down like this: 40 to 50 percent functional service offerings, in which the company takes over a whole department for a sponsor, sending in from five to 40 full-time-equivalent (FTE) employees for a specified period, anywhere from one year to 10 years. About half of the business is biometrics, the company’s bread and butter. More recently, Quanticate has gotten into consultancy. In such cases, a small, virtual sponsor will outsource just about everything while they get off the ground.

“We’ve seen a real explosion of that,” reports MacGarvey, adding that the fledgling enterprises, often spun off from research labs at universities or hospitals, and often with just one compound to bring into the clinic, may need help with study design, data strategy, putting together SOPs, and patient recruiting.

Quanticate, says MacGarvey, gets a lot of variety when it comes to trial phases. Currently, it’s an even, four-way split between Phases I and IV, with some pharmacokinetics work thrown in, too. Therapeutic areas? None in particular. “The trends in the market tend to drive the areas we’re working in,” says MacGarvey.

Simple = Better

Quanticate has an in-house electronic data capture/paper solution called ClinNav. MacGarvey is the first to say it’s very simple—old-school, developed approximately eight years ago. But that’s what customers like about it. It can be learned in an hour or so. It even has the look of a paper case-report form, virtual three-ring-binder and all.


Quanticate’s MacGarvey

But that basic design is not necessarily a liability, he says. “Investigators like it because it doesn’t have all sorts of added functionality,” says MacGarvey. “You can collect the data, query it and easily get reports. It’s liked by sponsors, too, because it’s back-ended by SAS. You can look at SAS output on an almost live basis. They like the reporting side of it.”

Improvements in the system are planned. To some degree the firm is following the model of Phoenix Data Systems, a division of Bio-Imaging Technologies, which has long held that data management can be best handled by people who know their own EDC system inside and out. Says MacGarvey: “We are creating a new version in .net that will sit on a SQL Server or Oracle back end. The new version will maintain the very simple interface that exists currently as it is the simplicity of the system that makes it popular with our user base.” Version III is due out by the end of this year. 

Thus far, MacGarvey says Quanticate hasn’t really seen the effects of the worsening economy. Studies that were started two or three years ago still need to be completed and their data still need to be analyzed.

Global Roadmap

The bad economy could even work to Quanticate’s advantage, as it may lead to more mergers, which often lead to sponsors outsourcing whole departments to functional service providers like Quanticate. MacGarvey says, “The model works so much better than the classic over-the-fence outsourcing,” and belt-tightening companies know that. “Plus, it gives them more control, as the FTEs log into their system,” he adds. He is, however, seeing just a little bit more cost-consciousness from sponsors.

Sponsors “will come back and challenge things like project management. People will say, ‘Do I really need to spend that much on project management?’ and then we will have to explain to them why it’s necessary. We didn’t used to have to do that.”

Quanticate has 10 employees in its Boston office, 196 in Europe, and 22 in Bloemfontein, South Africa. OPS set up that office in the summer of 2007, just before the merger. The plan, says MacGarvey, is to grow the employee base in Europe and South Africa by about 10 percent in 2009. The company expects overall growth of 15 percent this year. Might they accelerate that some? Perhaps. “It will depend on where we get to with the acquisitions and liquidity in the market,” says MacGarvey.