Case Study

More eRegulatory Experiences: Embracing A Paperless Process

clinical staff (002)

The point at which an organization arrives at the decision to transition from a paper-based research study management process to an electronic document management solution is the end of one journey and the beginning of another. Dustin Caldwell and Neal Surasky have been down that sometimes rocky path and completed the transition. And like seasoned travelers, Dustin and Neal have gained experience along the way that they are willing to share. This article presents their unique perspectives on that transition, from the early motivation, to challenges faced in working toward completion.

Dustin is the director of operations for OptiMed Research, a clinical research organization based in Columbus, Ohio. Founded in 1999, OptiMed is focused primarily on allergies and immunology.

Neal is the data manager and quality assurance coordinator for the Chesapeake Research Group near Baltimore, Maryland. CRG is focused on post-bunionectomy analgesic trials, and has recently expanded to include post-abdominoplasty studies.

They both learned that Even the smallest change in organizational processes and systems can unleash significant resistance among stakeholders. Comfort with old systems, however inefficient, can cloud judgment and blind them to the need for change. Read more to see how initial resistance or discomfort gave way to acceptance and appreciation.

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