The conventional wisdom is that a contract research organization (CRO) can't grow significantly it if it only works in the U.S. A global presence is obligatory for companies of a certain size. But not every CRO can afford to acquire other firms, especially in this economy.

Which is why some diminutive, geographically disparate CROs are banding together. Together, they can achieve global reach and get larger contracts. At least that's the theory.

Durham, N.C.-based CRO Health Decisions has just launched such a network, and its premise is a little different. The Agile Network, as it's called, requires interested parties to get certified in “Agile operations,” which are Health Decisions' proprietary set of best practices. Basically, new member must do business exactly as Health Decisions does.

Presumptuous? A good idea? For Health Decisions president and CEO Michael Rosenberg, it just makes sense. After all, the company has spent 21 years mastering flexible design principles and applying them to nearly all operations. It has the metrics to show that what it's doing works better than your average conventionally-run trial.

Good Metrics

Take enrollment. For most firms in the industry, 20 percent of studies actually enroll on time. “Using Agile methodologies, we enroll on time 80 percent of the time,” Rosenberg says. Query rates? He says the company turns those around in one to two days, in contrast with the five or more days typical in the industry.

Then there are monitoring costs, which constitute about 30 percent of the cost of a trial elsewhere. Rosenberg says that number is more like 18 percent at his company. Finally, database lock. Studies across the industry typically require between eight and 25 weeks to lock their database; Health Decisions needs two to four weeks.

“Our numbers are so much better than what the industry does that people find them hard to believe,” says Rosenberg. How is the company doing all this? Mostly, through flexible trial designs—in which the parameters of a trial can be changed if they are not working—and through widespread use of a scanning pen, which captures data from specially formatted paper and transmits it to a database. There's a video that explains the technology here.

'Hard to Believe'

Health Decisions, says Rosenberg, is all about doing things in real time, watching all elements of a trial for glitches or inefficiencies. When problems appear, the company jumps in and corrects them. Fast. The company uses an in-house electronic data capture (EDC) system called HD360, which offers mini-windows on each of the clinical staff members' computer desktops through which real-time data customized for their role is constantly updating.

Health Decisions is dedicating 10-15 of its 160 employees to getting the Agile network up and running. The company's main therapeutic areas include oncology, cardiovascular, central nervous system, reproductive and vaccines. It has worked on about 400 trials, about 100 of them overseas.

Formalized Sharing

Rosenberg simply wants all partners in its new network to be just as on the ball. “The whole point of this network is to take the model we've used around the world, systematize that and improve standards for the industry,” says Rosenberg. “This is a formalized sharing of best practices.”

The company's founder and chief business officer, Rick Farris, says that interested potential CRO partners must take six online classes. (Clinical staff that work with Health Decisions have to take from six to 10 classes). “We've tried to be careful not to be burdensome,” says Farris.

Thus far, four other CROs have learned the curriculum and joined the network. They are Argentina-based Klixar, which covers eight countries in Latin America; Russia-based Congenix; ClinResearch of Pretoria, South Africa; and HungaroTrial of Budapest. Twelve more companies are in the evaluation phase. Most are CROs that Heath Decisions has worked with. “The goal is to have 10 to 20 partners in total,” says Farris, adding, “This will give us global coverage.”

No Push Back

And sizes vary. “The first ones that were interested were smaller, then we started seeing some mid-sized ones, and now we have some pretty big CROs calling,” says Farris.

Have any of these companies balked at having to jump through the Agile Network's hoops? Surprisingly, no. “Nobody has pushed back; I found the exact opposite,” says Farris. He and Rosenberg are only requiring that one person from each CRO—preferably a project manager—take the classes, but many are having multiple employees take them. “They're excited to have the training, to learn about new, more efficient processes, and to bring in new business in this economic environment,” Farris says.

“Very quickly, you begin not wanting to do conventional trials because you find they're much more painful,” Rosenberg adds.

RFPs Already

And sponsors, hearing word on the street about the network, are already contacting Health Decisions about it. “We're working on three brand-new RFPs (requests for proposals) as we speak,” he says.

There are no fees to join the network or be trained in its principles. Farris and Rosenburg may incorporate dues as the network grows. Exclusivity—the concept of only having one CRO per region—is also under consideration. For now, the Agile Network is entertaining all comers. That is, comers willing to get with the program.

Here's a recent story on a similar network.

by Suz Redfearn 

d9A2t49mkex