CIO — Everything about Health Decisions screams small company with big plans. Fancy new office-park headquarters fit the company like hand-me-downs on a kid brother. A half sheet of paper next to the glass front door lists every employee’s name and extension, and people wander by would-be conference rooms in shorts or blue jeans. There’s even a six-passenger corporate plane.
Yet there is something unmistakably special going on at the Chapel Hill, N.C.-based clinical research organization (CRO), which designs and runs clinical trials for pharmaceutical companies and government groups like the National Institutes of Health. Health Decisions, whose $12 million annual revenue makes it the smallest Enterprise Value Award winner ever, is challenging a conservative industry’s accepted drug trial process with the resolve of the Little Engine That Could, an appropriate comparison given founder and CEO Michael Rosenberg’s favorite metaphor for his company.
"When James Watt invented the steam engine, people said, This is great because we don’t have to use water wheels anymore," Rosenberg says. "But for a long time people took steam engines and put them by the river." They didn’t realize they could save themselves the river trip by putting the engine where they worked?using the new technology to improve the process.
Health Decisions won an Enterprise Value Award this year because it is using technology to change the way pharmaceutical testing is done, not just retrofitting an old process with new parts. Health Decisions’ clinical management system can shave years off the drug development cycle and save sponsors millions of dollars. "It is an order-of-magnitude gain," says Partners HealthCare System Vice President and CIO John Glaser, a judge for this year’s awards. "This is beyond remarkable."
Pharmaceutical companies spend an average of $802 million and 10 to 15 years of research and testing to bring a new drug to market, according to the Tufts University Center for the Study of Drug Development. During that time, they are developing promising compounds, experimenting on animals, and testing on humans to find any adverse effects, determine dosage and ultimately see whether a drug does what it is intended to do. Most drugs don’t; only five out of every 5,000 compounds are ever tested on humans, and only 20 percent of drugs that make it that far are ever approved by the Food and Drug Administration. In short, it is a long and expensive process that often fails.
CROs handle the human testing, or clinical phase of the process. They collect results from the doctors’ offices that see the test subjects, check for mistakes and inconsistencies, and perform the statistical analysis. Currently, the vast majority of them do it all on paper, recording by hand the information they collect from patients?everything from date of birth to pain levels. Because so much time and money is at stake with a new drug, most pharmaceutical companies aren’t willing to experiment with other processes. Those CROs that do electronic data capture (EDC) through the Internet claim to be innovative, but all they’re doing "is substituting technology for something that is essentially a [manual] process," says Rosenberg. "They can get the data into the system faster, but they haven’t figured out how to use it faster."
