Pediatric Clinical Trial Experience

From ethics to recruiting to regulation, pediatric clinical research is worlds apart from working with adults.

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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

WHITE PAPER

Neonatal clinical trials

In this white paper, we explore the landscape of neonatal studies, from regulatory guidance and design considerations to challenges associated with study conduct and safety reporting. Learn how to increase the likelihood of developing and executing successful neonatal clinical trials.

PREMIER PERSPECTIVE

FDA RACE for Children Act

The RACE for Children Act aims to improve and expand treatment options for pediatric cancer patients by mandating that all new adult oncology drugs also be tested in children when the molecular targets are relevant to a particular childhood cancer.

Featured Resources

Premier Insight

Premier Insight

#272: Delivering the Global Expertise Required to Coordinate a Pediatric Gene Therapy Trial

White Paper

White Paper

Understanding New FDA Guidance for Pediatric Oncology Studies

Premier Insight

Premier Insight

#242: Overcoming a Next-to-Impossible Recruitment Challenge

Premier Thought Leadership

Angi Robinson

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.

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