Clarity’s Medical Writers Help Pfizer Meet FDA Guidelines

Challenge Pfizer, one of the world’s largest research-based pharmaceutical firms, needed assistance with its clinical studies documentation content development. Opportunity After a new medicine is developed, it must undergo a clinical trial phase that is documented in accordance with U.S. Food and Drug Administration (FDA) guidelines. Pfizer’s Clinical Communications Division needed to document its clinical studies, which were being prepared for submission by a specified deadline to the FDA. Clarity provided medical writers with relevant backgrounds in HIV and oncology research. Results The medical writers developed templates for the clinical documentation that conformed to FDA guidelines. They also developed and reviewed content to ensure that it was presented accurately. Clarity enabled the client to: • Produce scientifically sound reports in accordance with FDA guidelines. • Meet the FDA’s deadline for clinical studies documentation.