RALEIGH, N.C, May 4 (Korea Bizwire) — It is a little known fact that 70% of medicines given to children have been studied only in adults. As a result, most drugs used to treat diseases in children are used off-label. While there are pediatric clinical trial regulations in place, testing drugs in children continues to present considerable scientific, clinical, ethical and logistical challenges. In an effort to confront these challenges, PRA Health Sciences (NASDAQ:PRAH) is pleased to announce its new Center for Pediatric Clinical Development.
“PRA has a strong background in conducting pediatric clinical trials,” said Mark Sorrentino, Vice President, The Center for Pediatric Clinical Development. “We see this new center as an opportunity to establish PRA as the industry leader in pediatric drug development and bring innovation to pediatric clinical trial design and implementation.”
PRA has conducted the pivotal and/or supportive trials to gain 12 FDA and/or international regulatory approvals for drugs used in treating pediatric patients across multiple therapeutic areas. The Center for Pediatric Clinical Development is supported by a cross-functional group of experts who will provide strategic pediatric product development consulting services as well as experienced technical and operational services.
“This pediatric collaboration team provides the foundation for The Center for Pediatric Clinical Development,” added Sorrentino. “The team will provide pediatric expertise across functional areas into a single global resource to support all aspects of our clients’ pediatric product development needs.”
The team will help navigate the complexities of pediatric trials and brings a wealth of knowledge in understanding the diverse country-specific regulatory and legal challenges in the pediatric environment. One of the many benefits of the center will be a site network to accelerate patient recruitment, and improve patient engagement and retention.
ABOUT PRA HEALTH SCIENCES
PRA is one of the world’s leading global contract research organizations, by revenue, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and over 13,000 employees worldwide. Since 2000, PRA has participated in approximately 3,500 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 70 drugs. To learn more about PRA, please visit www.prahs.com.
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Source: PRA Health Sciences, Inc. via GLOBE NEWSWIRE