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International Clinical Trials

From Dumb to Smart

BACKGROUND

The business fundamentals of conducting clinical research have changed dramatically over the last few years. Although not quite as well-publicised as the recent events in world financial markets, the fundamentals of the industry have steadily eroded. Clinical trials are more expensive, take longer to run, and patient recruitment is harder than ever, to give just a few examples.

Even more worrying is the fact that the industry has been content to operate in the dark, with few objective metrics about the convoluted internal operations critical to planning and conducting clinical trials. For example, the Six Sigma methodologies that can be applied to the clinical development process have only recently been recognised by the industry, despite the fact that Six Sigma provides objective criteria that helps to measure the value of decisions. These decisions commit hundreds of millions of dollars to development programmes.

Furthermore, job cuts are occurring with increasing regularity, as are dramatic outsourcing arrangements and billion-dollar acquisitions. Unfortunately, while these big announcements garner a lot of attention, the actions often obscure the need to improve the efficiency and effectiveness of day-to-day clinical operations. In fact, the decisions related to crucial development activities that determine the successes of specific clinical programmes – and the overall health of the industry – are often overlooked.


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Edward Seguine is General Manager, Trial Planning Solutions, at Medidata Solutions, and is responsible for strategy development and execution. As a member of the senior management team at Medidata, Ed oversees all development, implementation and commercialisation activities for Medidata CRO Contractor, Medidata Designer, Medidata Grants Manager and the proprietary benchmark data these products rely on. Previously, Ed served as CEO of Fast Track Systems Inc, after moving from Eli Lilly, where he was instrumental in establishing both e.Lilly and Lilly Ventures. Ed is active in CDISC as the chair-elect of the Industry Advisory Board, a non-voting member of the CDISC board, and Financial Oversight Committee. In addition, he has written several articles and is a periodic speaker at industry events. Ed earned his BBA from Brigham Young University and MBA from Indiana University.
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Edward Seguine
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