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.
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 emerge once EDC's benefits become tangible, in the form of faster study closure and drastically lower data management costs.
Collins' move from a pharmaceutical to a CRO has taken her full circle. "Novartis stimulated demand for e-clinical 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-2008/2009, 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 U.S., 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."