At the end of the day, is electronic data capture (EDC) a technology? Or a service? It’s getting harder to tell.

At Phase Forward, Mike Davies says the EDC company reassessed its offerings to increase their appeal to CROs. As director of sales and global CRO partnerships, Davies admits the company could formerly have done a better job of explaining itself to the CRO industry. “We’ve tried to put together a program that is very different than how Phase Forward worked with CROs in the past,” says Davies. “We focus the program around one word:  flexibility.” He says it appeals to small CROs as much as global behemoths.

Indeed, the Waltham, Mass. EDC powerhouse has tweaked some of its contractual terms and internal sales incentives for CRO accounts. The idea is to make sure that Phase Forward and a CRO partner are never angling for the same business. “We changed the commissioning structure to make it more synergistic,” says Davies. “It’s one of the things I changed immediately. That helped us rebuild the trust with some partners.”

Customer Alignment

Specifically, “we’ve put creative approaches in place,” he says. “They can pay more in line with how they are paid by their sponsor. We’re more aligned.”

Appealing to CROs is a key part of the company’s strategy, he says, party because of unabated growth in the CRO industry: “These CROs see a lot more trials than we ever see. The successful CROs will adopt EDC, bring it in house, and drive more volume through that channel.” Quintiles, Icon, Parexel, Pharmalink and GleneaglesCRC are among the CROs using Phase Forward’s InForm solution for EDC.

But the issues of trust between the EDC sector and the CRO industry, while diminishing, are still present. Says Davies: “It really comes down to communication and understanding each other. There has been kind of this air of competition that has gone on between technology providers and CROs. Those barriers have to be broken down. For the ones that do let us get close, the barriers get broken down.”

Defending the Bid

Phase Forward has also recognized that EDC may impact an organization beyond its core users in the data management department, also affecting clinical operations, site feasibility and other stake holders within a CRO. “EDC doesn’t just touch data management,” Davies says. So the firm works with CROs in developing bids that reflect all users of its technology, he says.

On the technology front, Davies says the company’s infrastructure and tools to assess a site’s readiness for EDC are especially helpful to CROs, which may be trying to launch studies in hundreds of clinical sites all over the world. “Our remote site assessment and user management tools are very important to be able to allow CROs to manage those sites in those global trials,” he says.

He says the top dozen CROs, comprising perhaps 65 percent of the industry, are consolidating their business around a smaller number of EDC providers. “The major CROs are going to gravitate to the specific technology that the sponsors are using,” Davies says.

Let’s Talk

One of the delicate aspects of the CRO-EDC provider relationship, he says, is empowering the CRO so that the sponsor has complete confidence in a CRO’s use of the technology.

To make sure that happens, he says, Phase Forward tries to be as generous as possible with communication and training when working with a CRO for the first time. “In many respects, we’re the subcontractor to the CRO,” says Davies. “We have to be a lot more up front up and center and communicate more with our CRO.”

But once that’s accomplished, there is a natural learning curve with EDC, he says. CROs that use any system repeatedly over time will become more comfortable with it, requiring less support, to the point where they can, figuratively speaking, fly solo and build studies with less involvement from the EDC supplier in question.

One Address

Meanwhile, at Phase Forward’s archrival, Medidata Solutions, chief technology officer Glen de Vries says the company’s latest version of its EDC system, described in this article, will be able to radically simplify the administration of CRO users and their online training.

New York City-based Medidata serves some of the same CRO customers as Phase Forward, and has also enlisted Chiltern, EPS and UBC, as this web page suggests. INC Research is using Medidata, and seems quite content, as we wrote a while back. Medidata has a new four-tier certification program with varying levels of training; this summer, the company says, it will begin identifying which level of training a CRO partner has attained.

Despite the progress in signing up CROs, de Vries acknowledges lingering chilliness between EDC and CRO providers. “An important thing, that we hope is a differentiator, is that when we shake that CRO’s hand, we can look them in the eye and clearly say, ‘we are not going to compete with you.’ Competing with them doesn’t help us and doesn’t help them.”

De Vries stresses the low cost of getting started on the firm’s EDC platform, called Rave. In some cases, he says, the sponsor has the license for his EDC platform, the CRO can log into into the URL all that much faster. “For a CRO to start to build and manage studies in Rave, their entire investment is to get some training and set up a bookmark in the browser they’re using. That’s it. They just need the URL and they are off and running.”

Prediction: Consolidation

In some cases, de Vries says, CRO customers are either unsatisfied with or unable to afford separate, more complex clinical data management systems, and happy to see that Medidata’s platform can handle such work. Once again, installation and getting started is rapid, with a minimal learning curve or upfront expense. “If you look at those older systems,” he says, “that’s pretty uncommon. Typically there is an IT investment that a CRO would have to make.”

He doesn’t discount the competition. But de Vries suggests that sponsors will be comfortable with a shortening list of suppliers of EDC as the years pass. “CROs will be learning and supporting multiple EDC systems,” he says. “But the number of choices will be limited to the companies that become the standards in the space. The cost to sites of having to know and support twelve systems doesn’t make sense. It will probably come down to 2 or 3 [EDC] players.”

Editor’s note: This article is the second of a series. The first installment, an overview of the EDC-CRO landscape, can be found here. Our third article has IDC analyst Chris Connor’s assessment of the historical roots of EDC-CRO alliances. The fourth article addresses Kendle’s assessment of the EDC market.