There's no question about it: The drug-discovery business is booming. It's estimated that pharmaceutical companies invested $30.5 billion in research and development last year, marking an 18.7 percent increase over 2000, according to the Pharmaceutical Research and Manufacturers of America, a group that represents leading research-based pharmaceutical and biotechnology companies.
But research doesn't happen without risk. Studies can go wrong, and when they do, things get ugly. Consider cancer drug company Imclone Systems, which saw its stock price plummet earlier this year after the FDA questioned its study design. The government isn't shy, either, about suspending federal research dollars when research universities don't follow the myriad of rules and regulations. The FDA created a committee last October to follow clinical trials at both universities and private companies even more closely.
With so much at stake, there's a lot of room for products and services that help research projects succeed. That's where Scott Freedman, 42, and Rod Saponjic, 35, spotted their opportunity. They recognized a growing demand for clinical monitors--independent outsiders who, like good auditors, will make sure researchers play by the rulebook. Their privately held Gwynedd, Pennsylvania, Web-based start-up, MonitorforHire.com, pairs experienced trial monitors with sponsors of clinical studies. Says Saponjic, "We're answering a need that's out there."
Freedman and Saponjic secured nearly $1 million in private investment in 2000, just as many dotcoms were bombing. The site launched last February, and sales in 2001 approached $5 million. So far, more than 600 monitors and over 100 sponsors in the United States use the service.
MonitorforHire.com makes its profits from fees charged to the monitors, independent contractors who average seven years of experience and like the flexibility of working when and where they like. The company's four employees work in sales, administration and registration processing.
MonitorforHire.com plans to open registration globally this year. The founders' advice? Get some industry experience, make contacts and have a solid business plan. "Drug development is relationship-driven," Saponjic says. "If someone doesn't know you, you're going to have a hard time getting the time of day."