Technologically, Quintiles had been developing its own software for such projects. But after looking at 10 vendors, Quintiles was increasingly pleased by and impressed with etrials, eventually licensing its technology to them. "We are giving up our technology and control of our technology," says Stephenson. "Etrials has acquired our code."
Stephenson sees the relationship as symbiotic. "We actually get to rely on software and IT that are robust and industry-leading," he says. "We see customers coming to us in the context of the etrials relationship." (Quintiles will still accommodate customers with strong preferences for other vendors.)
Stephenson says Quintiles conferred with customers and did some soul-searching about its own core competency: "Historically, CROs have not been great at developing software, or recognized as industry leaders. The message we had from customers was, 'Guys, don't compete on technology. That is not what we're buying your services for.' We saw etrials as improving our product rather than competing." That is an interesting statement in light of other major technology vendors (such as Phase Forward) that also work with Quintiles.
One feature of the Quintiles-etrials deal is the easy delivery of paper-electronic (hybrid) trials. "You're not constrained to electronic data capture or paper," says Stephenson.
Allowing research-naive sites the option to use paper, he says, significantly increases the number of sites that may be interested in participating. In late-phase projects, he estimates, insisting on electronic data exchange (EDC) may exclude three-quarters of the eligible or interested investigators. And with a clinical data processing center in Bangalore, India, Stephenson says, "I couldn't care less how the data gets into the computer. Are we in the business of trying to force doctors to use computers? Or are we in the business of collecting data?"
To Stephenson, etrials is not just an EDC company. A certain amount of propaganda from the vendor community, Stephenson notes, has advanced the notion that the clinical landscape would be transformed after EDC: "Getting everybody to use EDC was going to solve everybody's problem. It's more complicated than that."
With the scope of post-approval projects, he says, not to mention the intermittent usage of such systems by investigators, more basic efficiencies matter. The fact that etrials can combine diaries, EDC, and clinical data management under the hood of one vehicle was appealing. Says Stephenson: "The only way you can cost-efficiently run certain designs of studies is to have that integration."