The tart-tongued disciplinarian of data management, Sylva Collins, is shifting her perspective. For years, Collins articulated the view that technology, appropriately applied, could lead to cost savings of massive proportions. She emphasized steadfast, unwavering support from senior management as a key factor in making electronic data capture (EDC) projects work.

Now that Collins has spent 18 months as VP of global biometrics at Kendle International, the contract research organization (CRO) has been focusing on service and process. Says Collins: “You have to have good processes, efficient processes to run EDC studies, and not take your paper processes and force EDC into it.”

Passing On Paper

She says that her firm, at the least, does not expect to use a long list of electronic data capture (EDC) suppliers and be as efficient or proficient as its clients demand. “We cannot excel in supporting every system,” she says. “We have to focus by choosing one and maybe two EDC systems.”

Collins reports Kendle is now doing 25-30 percent of its projects with EDC. In the industry as a whole, she says, the shift to EDC is well under way. It’s routine for customers to ask about pricing for both paper-based and electronic projects. “The demand has changed significantly from paper to EDC,” Collins notes.

Having said that, too many sponsors still ask for paper too often. “That is the biggest mistake. You can’t think paper any more,” says Collins. “You have to get out of that mind set.”

Data Standards

When she meets with clients, Collins says, her pitch is simple: “Let’s forget paper. Let’s talk EDC.”

Collins believes that proficiency with EDC could have profound consequences for any CRO that does not embrace and master the technology. “CROs who are not endorsing EDC will be out of business three to five years from now,” she says.

In general, Collins thinks the rigors of the marketplace will require CROs not just to master a small number of EDC solutions, but also to use data standards. “To be profitable, you have to standardize,” Collins says. “It’s hard to convince clients to use your standards. But clients are actually listening to us. This results in increased efficiencies for the client and the CRO.“

Tough Customer

Kendle has been doing some trials using EDC from ClinPhone. That by itself is a change of heart and (one would guess) a reluctant endorsement. Kendle has a suite of home-grown software developed specifically for clinical trials; Collins herself built EDC systems for Bayer and Novartis. She has never been inundated with flowers, holiday cards or birthday greetings from the EDC vendor community. In the early days of the field, she insisted that home-grown systems (if built correctly) could deliver stunning cost savings in the hundreds of millions of dollars.

Now she says that using too many EDC systems could be risky for any CRO. “You can’t just try every EDC system,” says Collins. ”It’s not the choice of the system that is critical. It’s all the support you have to provide so that you make it work. There is no perfect EDC system. The technology is an important component, but not the most critical.”

Finding a highly responsive EDC vendor, she says, is vital. “When you call them, and say, ‘I have an issue, they have to fix it,’” Collins says. “They cannot treat CROs based on how large the CRO is or how large the study is.”

Wanted: Support

The larger question about EDC suppliers, for Collins, is not just how well they can demonstrate their software, or what sort of testimonials can be obtained from this reference customer or that research analyst.

Instead, such mundane matters as support, training and other services around EDC are an overlooked area, and one in which the CRO industry will bring new operational expertise. “CROs have the resources and skills to use EDC and make it cost efficient for clients,” she says. “It is up to CROs to make it happen. At Kendle, we are doing that.”

Core Competency

Collins thinks the alignment of CROs and EDC firms will be crucial. “EDC vendors alone cannot make EDC successful,” she says. “They tried to provide CRO-level support. EDC vendors are not CROs and shouldn’t pretend to be them. They really don’t want to. They don’t have the people or the skills. They are software companies.” Most EDC vendors, she says, increasingly do understand where their own core competencies lie, and what should be left to the CRO community, and are working with CROs well.

In the Kendle-ClinPhone relationship specifically, Collins says she has let the technology firm know she expects its highest level of service. It sounds like she’s getting it. “We have a great relationship with ClinPhone,” she says.

In general, Collins says, she lets any prospective technology partner know that the right level of support for Kendle projects will be mutually beneficial. Says Collins: “If we make it successful, you will thrive. They know that. We work well together so far.”

Editor’s note: This article is the fourth in a series. The first installment, an overview of the EDC-CRO landscape, can be found here. The second article, on vendor strategies, is here. The third article, on alignment between CROs and EDC suppliers, is here.