“That the $3 million in anticipated savings derives from improved productivity among people collaborating more effectively across a variety of corporate operations and clinical trial processes. The automation and workflow improvements are obvious even at this early stage.”

"Missed arrivals and past expiration due dates are costly...What we've basically done is eliminate many of the opportunities for human error." - AnnMarie Dodson, director of information technology, DOV Pharmaceutical, Inc.

A domestic clinical trial by itself (without global sites), is a complex and delicate process—keeping track of a host of activities and milestones, keeping them on time and in compliance with the stringent oversight of the U.S. Food and Drug Administration. A report by the Tufts Center for the Study of Drug Development has cited clinical trials as the main contributor to the upward cost spiral in bringing a new prescription drug to market in the United States. The cost to bring a new drug to market now averages more than $880 million and extends over 10 to 15 years.

You’ve managed previous clinical trials using basic IT support and paper-based documentation: spreadsheets, conventional e-mail, faxes, overnight mail and the like. Now, the global coordination will be vastly more complicated, and any misstep could have costly consequences in delaying FDA approval

That was the challenge facing DOV Pharmaceutical, Inc., of Hackensack, New Jersey, in late 2004. DOV chose Protocol Manager™, a clinical trial management system (CTMS) from IBM and Winchester Business Systems, Inc. to meet the challenge.

The new CTMS was implemented in the spring of 2005, and after only a few weeks DOV managers were confident they were on track toward a positive return on investment by year-end 2006, with the ultimate goal of trimming $3 million off corporate operational and drug development costs in the same timeframe.

AnnMarie Dodson, DOV’s director of information technology, said, “That the $3 million in anticipated savings derives from improved productivity among people collaborating more effectively across a variety of corporate operations and clinical trial processes. The automation and workflow improvements are obvious even at this early stage.”