On Thursday, June 12, 2014, Premier Research announced that a panel of their experts will discuss the design of pediatric studies, recruiting for pediatric research, and the importance of corrective and preventive actions to a company’s quality system at the 2014 Drug Information Association conference, June 15–19 in San Diego.
The Philadelphia-based contract research organization will have two speakers and a poster presentation at DIA 2014:
Gloria Miller, a Premier Research senior auditor, will examine how a robust corrective and preventive action process is vital to a company’s quality system in her presentation, Responding to FDA 483s and Audit Observations: Implementing CAPA and Applying Root Cause Analysis — June 18 from 10 a.m. to noon.
Susan Tansey, MD, medical director for pediatrics, will discuss the challenges of recruiting for pediatric studies at a time of rapid growth in drug trials. Tansey will describe recruitment strategies that make parents feel more invested in the clinical trials process in her presentation, Parent Engagement: The Sponsor/CRO Perspective — June 19 from 10:45 a.m. to 12:15 p.m.
Rona Claire Grunspan, MD, and Jennifer Strickler, a Premier Research medical writer, will discuss the differences between pediatric and adult study design in a poster presentation: Easy as A, B, C? Adapting Pediatric Protocol Designs from Existing Adult Data and Study Templates — June 18 (#W42).
Premier Research will also be present on the DIA exhibit floor through the conference with a team of pediatric and rare disease experts at Booth #2011.
About Premier Research
Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs with a special focus on addressing unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 50 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.