DaVita Clinical Research Launches Advisory Preparation Services

DaVita Clinical Research (DCR) will launch its new Advisory Committee Preparation Services at the 2011 meeting of the Regulatory Affairs Professionals Society (RAPS): The Regulatory Convergence.

DCR will help lead drug and device companies from presentation outlines through execution at FDA Advisory Committee meetings. The Advisory Committee Preparation Services include two segments: presentation development and presentation execution. For presentation development, the company creates slides for sponsors that serve as visual aids, and then, through presentation execution services, mock rehearsals, Q&A preparation and slide retrieval for the delivery of those slides for sponsors. The company also offers services for other face-to-face meetings between sponsors and FDA, such as type A/B/C meetings.

As a part of this expansion, Lesley M. Smith has joined the DCR team. Ms. Smith is a practitioner and scholar in the area of strategic communication and recently earned a M.A. in strategic communication from the University of North Carolina at Chapel Hill.

“Successful slide development is a coordinated effort between clinical, regulatory and communication expertise,” said Mahesh Krishnan, vice president of clinical research at DCR. “Professional communicators move pharmaceutical teams toward their goal in a way no other function can — a lesson I learned from my own experience preparing for an advisory committee meeting.”