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Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials

By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore.  Read More



BioClinica Acquires Tourtellotte Solutions



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By Kevin Davies

September 21, 2009 | BioClinica, a publicly traded e-clinical service provider, has acquired Tourtellotte Solutions, a Massachusetts software firm founded by Ed Tourtellotte, best known for its supply chain simulation and interactive voice (IVR)/interactive web (IWR) software. BioClinica, which was forged when Bio-Imaging Technologies acquired Phoenix Data Systems 18 months ago, offers medical image management, electronic data capture (EDC), and other services to maximize manageability.

Peter Benton, executive VP and president of the eClinical division at BioClinica, says the firm was attracted to many aspects of Tourtellotte’s technology. “We’re looking for enhancements, anything that helps speed up and improve both the design and execution of clinical trials,” Benton told eCliniqua. “Whether it’s imaging, EDC, IVR… there’s a huge opportunity to bring radical improvements in the drug development process and in how products are brought to market.”

Tourtellotte says his overriding priority was to bring his small firm’s groundbreaking products to the clinical trial market. “There are many reasons why I’m thrilled with the BioClinica acquisition, but the most prominent is that we’re significantly accelerating our path into the world with what I think are next-gen clinical trial innovations,” he said.

BioClinica paid $2.1 million in cash, with additional payments up to $3.2 million and 350,000 BioClinica shares contingent upon achieving certain milestones. Tourtellotte Solutions generated nearly $4 million in revenue last year, a figure that is expected to approach $5 million in 2009. Tourtellotte joins BioClinica as vice president of product innovation.

Tech Targets
Back in 2004, Tourtellotte’s firm developed a novel piece of simulation software called tcVisualize, which enabled pharma companies to simulate the clinical supply chain, ensuring that sufficient drug supplies reached the sites. Launched in 2006, Benton calls tcVisualize, currently in use by four of the top ten big pharma companies, “a very cool technology. If it’s not bleeding edge, then it’s definitely leading edge compared to the alternatives, he says. “The competition is spreadsheets and manual calculations.”

Tourtellotte says his software helps pharma companies save 40-60% of the amount of a drug compared to what might have been packaged. However, “There are other times you have to package more drug to make the trial run right—the savings there is you’ve saved the trial. You’ve saved the emergency mitigations, which is very expensive.”

Listening to Tourtellotte reminds me of the old MasterCard commercial: Value of drug saved in a single clinical trial: $800,000. Cost of saving the trial: priceless.
 
Tourtellotte’s novel IVR/IWR solution, packaged as a product called Trident, is parameter-driven, built specifically for the web, and able to support rapid customization. The software is currently in use in more than 150 clinical trials, and has been used in some 300 trials overall. 

“The optimization/simulation market may be smaller,” says Benton, “but the ability of that combined with the Tourtellotte team’s expertise in managing the drug supply business, makes the technology developed in the Trident platform a huge opportunity.”

The IVR/IWR market may be growing quickly, but Benton charges there hasn’t been any new technology in the space for several years. “We think [Trident] is absolutely the latest and greatest technology of everything that’s out there. To some degree, the existing vendors and services are really suffering from an inability to quickly scale. With the private IVR we’ve built, and some of the principles underlying Trident, it’s all about quick building and scalability.”

BioClinica had a sizable IVR/IWR business, says Benton, but now plans to fully integrate Trident technology. From now on, says Benton, “If you have an IVR, you have an EDC; if you have an EDC, you have an IVR…. Customers may not buy all those technologies and services, but [we are] building a truly integrated solution that does not exist elsewhere on the marketplace.”

“We’re vehement in our passion for integration of those technologies,” says Benton.

Most of BioClinica’s clients also want the services to support the range of technologies on offer. Benton says that customers aren’t interested in juggling multiple datasets from an EDC vendor, their IVR vendor, their imaging vendor, their CRO, and so on. Integrating the Tourtellotte technology, coupled with BioClinica’s reach to most of the top pharma companies provides “a huge opportunity for cross selling.”

BioClinica and Tourtellotte had been talking for a long time before the deal was consummated. Tourtellotte says it was the “shared vision and shared goals” that persuaded him this was the right time. Benton says, “It’s the people, really,” which sounds like a cliché, but Benton pursues the point. BioClinica now adds the expertise of the Tourtellotte team to former Phoenix Data Systems and Bio-Imaging employees. “That’s what our customers are hiring,” Benton insists. “‘How can I get a study up and going as fast as possible?’ ... and our ability to react to the things that neither the sponsor nor us realize are going to go wrong.”

I asked Benton if this was BioClinica’s last acquisition for a while. “I don’t think so,” he said. “We announced CardioNow last week, Tourtellotte this week. At this point, we don’t have any plans for next week!” He adds that BioClinica has been run very conservatively, with no debt and plenty of cash in reserve. “We have a track record of doing smart acquisitions and culturally integrating these companies into a bigger stronger team.”

As for Tourtellotte, he first plans to finish and integrate Trident. And then? “Now we’ve got a real R&D organization and a real budget, not just a shoestring. You might see some more innovation from us!”

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