In a time of seismic rumblings, it’s best to remain flexible and alert. The contract research organization (CRO) industry’s newfound acceptance of technology is a geological event of that sort. It’s nothing ominous, but the landscape is shifting.
Shares of Ireland’s Icon are publicly traded, and doing nicely thanks to a 33 percent jump in revenues during 2006. Icon is the only CRO we know of with its own think tank. The company is aggressively looking at the registry and post-approval space, having acquired Illinois’ Ovation Research Group in June 2006. Head count is currently 4,800, spread over 30 countries.
We recently caught up with Tom O’Leary, Icon’s global head of data management. His company is familiar with more than a dozen EDC solutions and just selected Phase Forward as a preferred provider.
Tech Transfer
Under the usual terms of a technology transfer agreement, O’Leary says he envisions a transition to Icon using the Phase Forward technology internally, with less dependence on the Massachusetts company. “Icon will over time be the one who provides all of the services using this technology,” he says. “Phase Forward will just be providing the hosting of the actual application.”
Phase Forward and Icon are currently sharing the responsibilities for the study builds, but the CRO will eventually take on that work. “I see the adoption to be quite quick,” says O’Leary, perhaps a matter of 3-6 months.
Those Other Guys
There can be no illusions about this being an exclusive relationship. Icon has a similar arrangement with Phase Forward’s rival, New York City’s Medidata. “We have a strong relationship with Medidata,” says O’Leary. “That’s a relationship that will continue to exist and grow.” Both technology companies, he notes, are increasingly interested in serving the Phase IV arena.
To a fascinating degree, CROs selecting a short list of preferred providers could help to accelerate EDC consolidation in the industry. O’Leary says sponsors are increasingly eager for Icon to handle EDC-related tasks. That’s new. In the past, sponsors were not so ready to outsource such chores. “What technology does or should do is reduce the time to market for a drug,” O’Leary says.
“We see technology as one of the key tools to deliver efficiency,” O’Leary says. “We continue to bring new clients into Icon and win new business. The fact that we have this technology and are able to offer them multiple platforms that we can tailor to their needs is something that sponsors want to see.”
Parallel Processors
Generalizations are difficult, of course. But preferences for one EDC supplier over another may be more deeply felt in large pharmas than in the world of biotechnology and small or mid-sized pharmas. “From an Icon perspective, we want to make sure we can offer any of the technologies that are available in the marketplace,” he says. For any project, for any client, the right EDC solution may vary, he says.
O’Leary notes that the legendary startup times for EDC are not fixed mathematical constants. With the right planning and team, he says, Icon can get the system ready for the first patient and, once that’s done, prepare for later visits in the study. “There are ways in which you can do many of the activities in parallel,” he says.
Paper Chase
He acknowledges the central role that paper continues to play, even in so-called “electronic” studies, but he’s not awaiting any dramatic, instantaneous transition. “Paper in many senses should go away,” he says.
Which is not to say it will go away, O’Leary adds. “The paperless environment has been spoken about for quite a considerable amount of time. You have to start with the children at school. The moment they’re not using paper – that’s the moment this will carry through to the business world. When paper can be eliminated I wouldn’t hazard a guess.”




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