April 12, 2007 | When it comes to electronic data capture (EDC), standardization breeds success, says Sylva Collins, vice president of global biometrics at Cincinnati, Ohio-based Kendle. The publicly owned clinical research organization (CRO) recently brought the pragmatic Collins on board to provide leadership for its global biometrics offerings and help it become “the unparalleled leader in e-clinical services.”
The immediate goal is to “standardize on one or two [EDC] systems,” says Collins. Heretofore, Kendle has utilized several systems, including those of Oracle Clinical, Medidata, DataLabs, and Phase Forward, as well as its own in-house EDC system. It has used EDC on about 150 studies to date.
Prior to joining Kendle, Collins led an initiative at Novartis that in a single year (2001) converted data capture from “100 percent paper to 100 percent electronic,” she says. The focus was on a single system, using PhOSCo open source software as a base and customizing it to suit the company’s working practices and reporting requirements. (see Master of the EDC Universe, Bio-IT World, Aug. 2004) Collins headed the global electronic data management operations for more than 400 EDC studies involving about 130,000 patients and 16,000 investigator sites on six continents.
EDC technology could hardly be termed new, says Collins. She helped Bayer implement EDC back in 1989, “before the Internet, laptops, and high-speed modems.” Others, including Merck and GlaxoSmithKline, were experimenting with EDC before then. But only recently has any EDC vendor had a product capable of an aggressive scale up.
If Collins has a mantra, it’s that EDC is “not an IT project. That’s a big mistake and almost always fatal.” Choosing the software is but a tiny piece of the picture. “EDC impacts thousands of people and yet at most companies, [it] is just another cost to the IT department,” she says. “It’s the support systems built around EDC that make it successful.” Top-notch user help desks are “critical,” as are developing the proper work processes, standard operating procedures, and, perhaps most importantly, employee mindsets.
Starting the Process
The march to EDC requires a change in job skills, reporting relationships, and expectations among internal users. “Human nature being what it is, there is often some resistance,” says Collins. Perkier attitudes tend to merge once EDC’s benefits become tangible, in the form of faster study closure and drastically lower data management costs.
Collins’ move from a big pharma to a CRO has taken her full circle. “Novartis stimulated demand for eClinical services among other sponsor companies, which [now] look to CROs to provide those services,” she says. “Kendle recognizes that it must strengthen its internal e-clinical expertise to remain competitive with other CROs. It’s an enhancement I have pushed for 25 years.”
The quest for EDC dominancy is all part of the “Kendle 500” global growth strategy that is focused on aligning Kendle’s expertise in five global regions to meet needs in the fastest-growing therapeutic areas. The company has the mid-term goal of reaching $500 million per year in revenues by mid-2008 to 2009, says Collins. It passed the halfway mark in 2006. Last year, Kendle also acquired the Phase II-IV clinical services business of Wilmington, Mass.-based Charles River Laboratories, making it the world’s fourth-largest provider of Phase II-IV clinical development services, with operations in more than 80 countries.
Collins says her responsibilities at Kendle will include global biostatistics, data management, and scientific programming. She will be providing leadership to data centers in the United States, Europe, Australia, and Mexico that are staffed by more than 500 associates. “My expertise is a good match to take Kendle to an EDC leadership position in the [CRO] industry.”
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