Originally Published MPMN November 2006

INDUSTRY NEWS

Contract Research Organization Turns to India for Clinical Trials

Shana Leonard

Because of its extensive cheap and skilled labor pool, India has emerged in the global marketplace as a top destination to meet the outsourcing needs of the computer and IT, as well as pharmaceutical, industries. And it appears as though the mecca for outsourcing activity can add one more service to its lengthy résumé: medical device clinical trials.

Contract research organization Alquest Inc. (Minneapolis; www.alquest.com) has staked its claim as offering the first device-focused clinical trial service in India. In response to recurring problems impeding stateside trials, the company sought solutions elsewhere.

“The clinical studies we were involved with in the United States were continually struggling to get enough patients,” explains Linda Alexander, CEO and founder of Alquest. “We recognized that the U.S. market is pretty saturated with clinical studies and device solutions, and so we needed to find a way to increase our patient enrollment so we could get the necessary studies done more quickly.”

Stymied by slow patient enrollment, U.S. trials can drag on for long periods of time, subsequently raising costs and delaying time to market for medical devices that could potentially be improving patients’ health. Costing an average of $500,000 to $1 million per month, U.S. clinical trials can put a significant financial strain on the pockets of smaller companies, according to Alquest. Because of this burden, the organization identifies North American and European early-stage and mid-sized device firms as those who will benefit most from its expedited trials in India.

Teeming with a diverse population of more than 1 billion people, India has no shortage of patients for clinical trials. And since people must pay for their own healthcare, many patients are eager to participate in the trials. While Alquest does not offer compensation, it does provide free healthcare to participants. Furthermore, this promise of free healthcare has the potential to boost patient retention—a problem that plagues U.S. trials. The combination of these factors results in smoother, quicker, and, ultimately, cheaper trials, according to the firm.

While the large population and low costs establish India as a prime place for trials, Alquest points out that there are additional benefits to conducting trials there. It cites the prevalence of English speakers, the practice of Western medicine, and the use of modern technologies as further reasons for conducting India-based research.

Although some companies may have reservations about outsourcing to India for a device that needs FDA approval, Alexander maintains that the data being collected is FDA quality. “I think that we’re going to find that FDA approvals will be very easy to come by,” she says. “FDA is really open to receiving foreign data when it is controlled according to U.S. standards, which is part of what Alquest brings.”

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