Not so long ago, Icon Clinical reached the final stage of getting regulatory approval for a large global project involving a new diabetes drug. As fate would have it, the FDA issued a warning letter about another drug in the diabetes category. The regulatory counterparts to the FDA elsewhere in the world said a collective whoa.

In brief, there was an entirely new level of scrutiny on Icon’s client’s project. New questions. More meetings. “We lost about three months,” notes John Hubbard, the firm’s global president, whom we spoke with a while back when the economy was still looking a bit more apocalyptic than it does today. For some firms in the industry, a three-month setback and sharply heightened regulatory oversight would mangle the trial’s time line.

Not for Icon. In some cases, the contract research organization (CRO) accompanied the sponsor to visit the regulatory officials. Once the approval to start the trial was in hand, Icon expanded the study into a few additional countries. It hired external patient recruitment wizards. It made things happen.

In the end, the company finished the trial one week late. As it happened, it was in the same calendar month that it had been originally scheduled to complete. “These things happen,” says Hubbard philosophically. “We were dealing with the situation and we were dealing with it at the highest level of the organization.”

Still Growing

Many companies can do what Icon did with the diabetes drug. But it seems like Icon can pull off such feats a bit more routinely.  In its contract wins and recent growth, there is a sort of effortless effort, an ability to keep apparently irretrievably delayed projects on track.

Which is all the more unusual since Icon is competing against large and sophisticated peers that are themselves not novices at global clinical development. The Irish-headquartered company expects to grow even this year, amid a global economic collapse, and we chatted with Hubbard to try to learn the recipe for the company’s secret sauce.

“When things are a little bit more challenging in the market place, you have to retrench and adjust your strategies and stay close to your clients,” he says. “I am still pretty bullish about the industry in general.”

Avoiding Cancellations

The sauce turns out to not be so secret. Listening. Flexibility. Proactively contacting customers when the inevitable bumps in the road are hit. In one case, Icon elected to wait while a very young sponsor company scrambled to find additional funds for a promising trial that had already begun. In the end, the sponsor located the resources it needed, and Icon’s bill was paid.

Hubbard was nice enough to point out that some of his competitors are seeing cancellation rates perhaps three times what Icon is experiencing. And there is no evading the unprecedented difficulty of the macroeconomic environment. But Icon believes the future of the industry as a whole is as bright as ever, with prospects for double-digit revenue growth that many other industries can only dream about.

“We’ll get through this,” he says of the current recession. “I don’t think it changes the fundamentals.” But there is no question the current situation is fluid. The sponsor may award a trial, and decide to pull it in-house a week later. “That indecisiveness is an indication of the pressure companies are facing,” he says. “There is more volatility.”

Full and Functional

In that context, it’s interesting to reflect on whether the full-service outsourcing model could be dead. The bulk of the births in new services firms, for the past few years, has been CROs that maintain rigorous focus on one or two tasks: data management or monitoring. That’s lead some pundits and analysts to wonder if the mammoth CROs doing everything (the full-service model) could face long-term pressure.

Hubbard says the industry will support both the full-service and the specialized functional approach. “They are not mutually exclusive,” he says. His own firm, he notes, supports both.

The more pressing issue for the largest CROs is being able to support global research projects as complex as NASA launches or military mobilizations. “The old way of outsourcing is over the wall,” he says. “You’re not taking advantage of economies of scale, of volumes of learning curves where people learn to work together and become more efficient.” Few small CROs, he predicts, will find building a global presence easy or to be pain-free.

Trial Stoppages

In some cases, he says, what the sponsor community wants are the basic tenets of Customer Service 101. “Stability is important,” Hubbard says. “Clients want to be talking to the same people today and tomorrow. It’s basically blocking and tackling. You don’t have to be fancy. You have to get the job done in a consistent way.”

Hubbard concedes that there are some similarities between all the large CROs, but believes Icon may be unique in its ability to bring the insights of senior managers to bear. “What we’ve been able to demonstrate is a high level of senior management involvement and problem solving,” he says. “We really do tend to work collaboratively.”

One of the most delicate topics facing any CRO in the current climate is when to close a trial because a sponsor has run out of money. Hubbard, as a physician, says that in addition to the obvious financial implications for everyone involved, there are a variety of other considerations. “If you’re going to shut a trial down, you have all sorts of ethical and medical implications,” he says. “It’s not like switch and it’s off.”

Rapid Response

At times, keeping the trial going is the right call. Says Hubbard: “It isn’t something that is going to be a routine part of the business. We look at this in a very measured cautious way.”

As the downturn deepened late in 2008, he says, Icon relied on its customary, ordinary attention to the tiny details of trials and clients. “We have meetings every Monday morning with operations and business development and finance and review where we’re at. It’s the level of detail you watch and how quickly you make decisions that drive how fast you can respond.”

Technology is helping in that regard, he says. “Technology is necessary,” Hubbard says. “EDC is here. For a while people hadn’t quite embraced it. The software wasn’t where it needed to be. Clearly, now it is.”

The firm works with a variety of electronic data capture (EDC) suppliers, but has the deepest relationships with the largest suppliers. For the CRO industry, he acknowledges, there is still work to be done in realizing EDC’s potential.

No Blame

“All of us still have a way to go to fully utilize EDC technology in a way that is more efficient in how we go out to sites, how we use monitors. That’s coming,” Hubbard says. “Companies are starting to say, I understand how you can monitor less, use the technology and utilize more information and still ensure you get good source document verification.”

Part of what works at Icon, he says, is a culture that identifies problems but does not believe in blame, finger-pointing and scapegoating. “Stuff happens,” says Hubbard. “It’s a lot easier to put out a smoldering cigarette than a forest fire. But we are not a company that is blame focused.”

The goal in fostering Icon’s culture, as best we can tell from the outside, has been to use the collective brainpower of the firm to come up with solutions, not single out individuals responsible for glitches. Says Hubbard: “When you’re not [a blame culture], people are more likely to be open around problems. If people are scared, they can hide things. When they are open about it, you can get on top of it.”

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