Contract research organization (CRO) Kendle International (Nasdaq: KNDL) has chosen ClinPhone as its electronic data capture (EDC) vendor, and that comes as something of a surprise.

Not because of ClinPhone, which is ramping up efforts to play in the most bruising tier of the EDC arena. What’s stunning is the choice of an outside EDC supplier at all.

The person doing the choosing was Sylva Collins, Kendle’s new vice president of global biometrics and a former opponent of using outside EDC vendors. She has both tantalized the pharmaceutical industry with estimates of massive EDC-based cost savings—and tormented clinical trial technology companies with sharply worded assessments of the functionality of their systems. 

Building, Not Buying

In 2001, Collins created her own in-house EDC system at Novartis, complaining that outside vendors’ solutions were not mature enough to deliver what they promised. Besides, they were too expensive. She did the same thing in 1989, when she worked for Bayer.

But that was then. And this is now. “EDC definitely wasn’t ready for prime time,” says Collins, who joined Cincinnati-based Kendle last fall. “But there are definitely more systems in the marketplace now that are more mature.”

What’s different? Collins laughs. A lot, she says. Now we have high-speed Internet, laptops, better connectivity, and the ability to do aggressive scale-up. None of that was in place back when she was chortling at nascent EDC vendors knocking on her door at Bayer and Novartis.

Also, back then, investigators weren’t ready for EDC adoption. “That’s definitely not the case now,” she says.

Standards, Pricing

Collins has kept a close eye on the software-vendor community throughout her career while handling, she says, 700 EDC trials in 60 countries. The EDC guru and her team evaluated five vendors during the first quarter of 2007—she won’t say which ones—before declaring ClinPhone the victor.

What does Collins like about ClinPhone’s solution? “It’s very easy to use, has serious [CDISC] compatibility, competitive pricing, system performance, and vendor support as well,” she says. 

Kendle already had some knowledge of what ClinPhone (formerly DataLabs Clinical) could do. Charles River Laboratories, from which Kendle acquired a Phase II-IV clinical services business last August, had adopted ClinPhone’s EDC solution.

Organizational Transformation

But Collins is the first to say that Kendle’s decision to go with ClinPhone as its standard solution doesn’t endorse the ClinPhone product as much as it highlights Kendle’s willingness to undergo a total shift in how it conducts business.

“The choice of the system is not the most critical factor in making EDC successful,” Collins says. “From my experience, for successful implementation of EDC, we must look at the whole business process and not just the software. … A piece of software cannot make an organization do what its management cannot make it do. [Adopting EDC] is really a management business process redesign. Deployment of it is a management exercise.”

Why now? “Kendle recognizes the inherent advantages of EDC,” says Collins. “Speed and data quality will ensure continued growth in this area.”

Big Growth Coming

Collins points to a Frost & Sullivan report that shows that between 2001 and 2006, the EDC market swelled from $120 million to $300 million. The market is projected to hit $700 million by 2012. While EDC is used in 30 percent to 40 percent of trials now, it is expected to be in use in 70 percent of trials by 2012, said the report.

But Collins thinks the future of EDC is even brighter than that.

“When sponsors recognize the disadvantage they are suffering by continuing with outdated methods, I think it will lead to EDC adoption at faster rates than are forecasted,” she forecasted.

Old Friends

In the here and now, though, Kendle expects to achieve big economies of scale with the adoption of one standard EDC solution—where before it was using three or four, says Collins. She adds that those savings will also be passed on to sponsors who choose to have Kendle use ClinPhone for their trials.

Of course, sponsors can also select any of the other EDC solutions Kendle offers, but it won’t save them as much, she says. The economies of scale just won’t be there. This year, for the first time, CROs of all sizes have begun aligning themselves with one or two EDC suppliers; the Quintiles selection of Phase Forward is just one example.

Other EDC systems that Kendle has used include Oracle Clinical, Medidata, DataLabs and Phase Forward, as well as its own in-house EDC system. It has used EDC on about 150 studies. Kendle is the fourth-largest provider of Phase II through IV trials worldwide.

Collins has brought new hires onto her team to provide technical support for customers, but she won’t say how many, or who they are. She would only say that they are former colleagues of hers, and that one will be Kendle’s director of EDC support.

A Sharper Sword

She did not hesitate, however, to say that Kendle’s adoption of a single EDC solution from an outside vendor—something that would have been unthinkable for Collins back in the day—will help her new employer quash competitors.

“We are all excited at Kendle,” says Collins. “We will be the leader in the industry at providing best-in-class e-clinical services that will result in faster database lock and data quality that are unrivaled in the industry—all at competitive costs.”

—by Suz Redfearn