EventSpan

Speaker:

Gregory P. Cuppan

Speaker:

Philip Bernick

Full description:

It is difficult to overestimate the importance of sound document review methods for the pharma ceutical and medical device industries. Much time is given to document review, yet review practices remain remarkably frustrating to participants, as they are frequently inefficient and poorly man aged. This session is designed to discuss cause and effect of poor review practice, solutions to enhance the value and increase the efficiency of reviews.

In just one hour we will discuss current review practices with an emphasis on what research tells us about best practice. We will look at some problems with document review in the realm of clinical research where document reviews almost always engage a team of professionals, entail multiple reviews, and are often fraught with second guessing and continual “tinkering” with the document right up to publishing deadlines.

We will discuss how document review practices observed across industries tend to reinforce non-productive organizational behaviors. We will offer a case study on the development and application of review tools. We will present a set of recommendations designed to encourage efficient and productive review practices.