Pediatric Clinical Trial Experience
From ethics to recruiting to regulation, pediatric clinical research is worlds apart from working with adults.
Leverage our pediatric clinical development expertise
Pediatric patients are not simply miniature adults.
Most medicines given to children have been tested only in adults, raising numerous concerns about efficacy and safety. That’s changing, and it has become clear that pediatric trials require a special approach.
To succeed in pediatrics requires a deep understanding of childhood diseases, from the familiar to the extremely rare. And it requires a unique appreciation of the variety of young people from toddlers to teens and how to work with them and their families.
Why choose Premier?
- More than 180 pediatric studies completed over the past five years
- We created our own pediatric certificate training program for all operational team members
- Six years as sole coordinating center for the Best Pharmaceuticals for Children Act
Developing pediatric analgesia trials
When it comes to pediatric analgesic clinical trials, protocols cannot be simply “cut and paste.” Researchers engaged in pediatric trial design must consider the specific physiology, pharmacology, and normal daily activities for each group being studied.
Top concerns for pediatric study participants
Patient and parent engagement is crucial for successful pediatric drug trials. That’s why the best strategies are ones that encourage proactive involvement beginning at the early stages of protocol development through study conduct and eventual results-sharing.
Premier Thought Leadership
Angi Robinson has been conducting pediatric and rare disease studies at Premier Research for more than 14 years. She has provided oversight and full management support for over 30 rare disease studies, including multiple U.S. and global programs. She has also supported FDA pre-IND meetings, IND submissions, and NDA/BLA project directorship.