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View on Submission Process Management

In an exclusive to PharmaVOICE, Jim Walker, President and CEO of Octagon Research Solutions, explains how productivity and efficiency, compliance and quality, predictability and optimization, and flexibility and extensibility offer a strong framework for designing effective process management.
As the industry moves toward an ever-increasing volume of electronic submissions, managing the volume and complexity becomes a daunting task.
Process management is an emerging concept in the world of biopharmaceutical research and development. There are numerous macro business drivers that have necessitated the development of business process management principles within clinical research and development. According to the Tufts Center for the Study of Drug Development, the current cost of bringing a new molecular entity to market is estimated at $897 million…

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Jim Walker, President and CEO, Octagon Research Solutions