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DaVita Clinical Research
will launch their new Advisory Committee Preparation Services at the 2011 Regulatory Affairs Professionals Society (RAPS):
The Regulatory Convergence
DCR’s team helps lead drug and device sponsors from presentation outlines through execution at FDA Advisory Committee meetings. Sponsors benefit from a strategic partnership with dedicated presentation experts who translate messages into powerful slides in real time. DCR’s team, which has participated in more than 20 advisory committee meetings during the past six years, works side-by-side with sponsors to help ensure advisory committee communication is complete and effective.
The Advisory Committee Preparation Services are divided into two segments: presentation development and presentation execution. DCR’s role in presentation development is to create slides for sponsors that serve as powerful visual aids. Then, through presentation execution services – mock rehearsals, Q&A preparation and slide retrieval – the DCR team facilitates the effective delivery of those slides for sponsors. Similar services are available for other face-to-face meetings between sponsors and FDA, such as type A/B/C meetings.
DCR is pleased to announce as a part of this expansion the addition of Lesley M. Smith to the DCR team. She recently earned a M.A. in strategic communication from the University of North Carolina at Chapel Hill. She is the only slide developer in the advisory committee preparation industry to write academically on the topic, conducting research on the presentation of data at drug advisory committee meetings.