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No small change
"We visited sites and listened to them. We tried to understand their business processes and how they worked so we weren't disrupting how they worked," says Goodwin. One of the seemingly simple, yet stunningly effective ways that I-Net leaders helped the computer-phobic gain confidence was by designing the CRFs (in PDF format) so that they looked like the hard-copy CRFs. And though at first they sent technical staff out to sites for training, as users became more comfortable with technology, Pfizer began training for clinical trial sites online.
The enthusiasm of internal users also rubbed off on external users. Goodwin says he and other leaders cultivated business champions -- lead clinicians, lead clinical research associates and lead data managers who wanted I-Net for their projects.
Pfizer faced different sets of challenges when implementing I-Net globally. "How do you get laptops into Estonia or India? It's easy to ship paper; when you ship electronics, there are a whole lot of different import restrictions," says Anthony Gazikas, worldwide head of development informatics at Pfizer Global Research & Development. Infrastructures in other countries are not always optimal -- users need to be convinced that the payoff from using I-Net is worth, say, the creaky 28.8Kbps connection, which may be slower than paper. To support its global users, Pfizer put in place a 24/7 multilingual help desk that supports all trials.
The cultural differences in the way doctors work around the world also need to be taken into consideration. For example, in the United States, I-Net may be programmed with plenty of edit checks -- say, if a trial participant weight is entered as 300 pounds, the app might generate a pop-up that asks, Are you sure this is correct? In Japan, however, a doctor might take offense at being questioned by a computer, Goodwin says, so Pfizer is less likely to program edit checks into a Japanese-based system.
Whether introducing new technology to doctors in Japan or cops in Chicago, the change management strategies employed by these four organizations have helped boost the acceptance rate of their systems. It may have worked for Kevin Costner when he constructed his ballpark in an Iowa cornfield, but companies know that if you build it, they don't always come. In these four cases, users have come, and, as a result, the systems have been a solid hit.