Pediatrics

Supporting young patients in clinical trials

Despite recent regulatory changes in pediatric drug development, most medications given to children are still “off-label,” having been studied only in adults. Pediatric clinical research poses unique challenges that require careful planning and strategic expertise. At Parexel, our dedicated team of pediatric experts will support you through the pediatric clinical trial pathway from start to finish. From identifying the best sites, maximizing patient recruitment, and handling technical and logistical challenges, we have the specialized knowledge and resources to successfully run your pediatric trials.
 

Our pediatric practice is distinguished by:

• Over 20 pediatric physicians worldwide with expertise across many pediatric subspecialty areas.
• Clinical trial experience across all pediatric areas.
• Global regulatory specialists with expertise in developing Pediatric Investigation Plans and Pediatric Study Plans.
• Innovative approaches to conducting pediatric clinical trials, including virtual and adaptive trial designs, as well as real-world data approaches.
• Expertise with modelling and simulation, pharmacokinetics and pharmacodynamics, and pediatric formulations.
• A Patient Innovation Center dedicated to providing patient-centric approaches.
• Recruitment strategies including providing clinical enrollment managers and an informed consent video.
• Collaboration with a broad network of pediatric site alliances, Site Management Organizations and larger pediatric networks.
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Over the last 5 years, Parexel’s pediatric experience has included:​​​​​​​