Industry Trends

Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials

By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore.  Read More




Clinsys Ecstatic over TrialStat CA EDC Acquisition



By Deb Borfitz

January 26, 2009 | Clinsys Clinical Research reconfirmed its commitment to electronic data capture (EDC) last November when it acquired TrialStat ClinicalAnalytics (CA). Thanks largely to its new flagship EDC offering, the Bedminster, NJ-based global clinical research organization (CRO) has already landed three large EDC studies, says CEO David Williams.

A demonstration of the “affordability and strength” of TrialStat CA convinced sponsors to make the switch to EDC, says Williams. The system’s main selling point is that its software-as-a-service (SaaS) architecture is 100% web-based and thus requires no special software or in-house IT know-how.

David_Williams
David Williams
Clinsys is a wholly owned subsidiary of Jubilant Organosys, a custom research and manufacturing/drug discovery and development services company based in Noida, India. It has offices in the U.S., Canada, Germany, and two sites in India, including a full phase I unit in Noida and a data management and biostatistics branch in Bangalore. It also manages studies in more than a dozen countries across Europe.

Nearly one-third of the CRO’s 400 employees are based in India, says Williams. “We use India as a second shift and extra pair of hands for the quick turnaround work we do for sponsors. We manage all global trials from the U.S. for now, but that may change.”

Clinsys has been and will continue to be a Medidata Rave-accredited company, says Williams. Market-leader Rave is a more commonly used and more expensive EDC alternative to TrialStat CA.

To date, TrialStat CA has appealed to small and mid-size pharmaceutical, CRO, and biotechnology companies—all of whom have opted to remain customers post-purchase, says Williams. It’s the economical choice for those companies looking for comparable pricing to paper-based studies.

The opportunity to purchase TrialStat came about rather suddenly when the private-equity-funded company entered into receivership, says Williams. A month later, Clinsys had closed the deal, recognizing that an in-house EDC solution is a “strategic differentiator” that will generate additional business.

TrialStat CA is the first and one of the only commercially available SaaS EDC systems, making it easier to use as well as highly scalable and flexible, says Mitchell Winfree, vice president of global business development and marketing. “For example, edit checks can be made in ten minutes versus hours with competing systems.” Other commercially available EDC systems are accessed through the web, but they require some type of hardware or software installation.

While TrialStat employees will remain in Ontario, Canada, new hires will be made “throughout the world” as needed, says Williams. This includes additional staffing in India to provide 24/7 call center coverage.

“We’re proud of this acquisition and the speed at which it happened,” says Williams. “We expect it will add substantially to the organization’s top and bottom lines.” Of the trials Clinsys currently manages, about 70% are paper based, 30% are EDC. But Williams anticipates a shift to more EDC-based studies in the future. Industry wide, EDC is now used in approximately half of all studies.

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