Karen Kaucic, M.D., PPD senior vice president will head the center of excellence out of the company’s Rockville, Maryland, office. The center’s 23 team members will be located at various PPD locations, along with six members of a steering committee.
According to the company, the team will be able to support end-to-end clinical trial solutions, including feasibility strategy, clinical information, biostatistics, pharmacovigilance, lab operations, and business analytics.
“The center provides consultation on pre- and post-approval program and protocol development, innovative approaches to patient access and site management, strategies to address coordination of complex trial logistics, and application of customized patient-centric solutions to rare disease trial execution,” Dr. Kaucic told us.
“Given that at least half of rare diseases touch children, we believe our approach of combining rare diseases and pediatrics within the center enables a more integrated approach to efficient delivery of rare disease programs,” Dr. Kaucic added. “In addition, many of the patient-centric and customized approaches developed for rare diseases are highly relevant in pediatric clinical trial delivery more broadly.”