Pediatrics - Premier Research

Leverage our pediatric clinical development expertised

Age makes a difference in medical care.

Adults react differently to medicine compared to children and adolescents. Still, 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 an appreciation of the various stages of childhood development from birth through late adolescence.

Why Choose Premier

More than 250 pediatric studies completed over the past five years
Specialized training is delivered to our operational team members, including a custom pediatric research training certification program
Six years as sole coordinating center for the Best Pharmaceuticals for Children Act
Project teams benefit from strategic insights of trained pediatric physicians with years of clinical and R&D experience
Considerable depth of regulatory expertise, including frequent support of Pediatric Research Equity Act requests and waivers

Perspectives Blog

Understanding Recent Regulatory Changes for Pediatric Oncology Trials

Of the 1.7 million new cases of cancer in the U.S.

5 Things to Know About the FDA RACE for Children Act

The Research to Accelerate Cures and Equity (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.

Perspectives Blog

Food for Thought: The Power of Decentralized Clinical Trials in Accelerating Infant Formula Studies

Infant formula is an essential food product that serves as the sole source of nutrition for many babies in North America and Europe during their first year of life, supporting health, growth, and development.1,2 More than a year since the shutdown of the largest infant formula plant in the US in February 2022, the country is still feeling the shortage.

Angi Robinson

Senior Vice President

Specialty Areas (Rare Disease, Pediatrics, Cell & Gene Therapy)

Adam Bloomfield, M.D.

Medical Affairs, Rare Disease and Pediatrics

Leslie Wetherell

Executive Director, Program Strategy

Rare Disease and Pediatrics

Jackie Brown

Vice President, Project Delivery

Rare Disease and Pediatrics

Betsy Reid

Senior Vice President

Pediatrics, Infant Nutrition

Resources

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

Understanding New FDA Guidance for Pediatric Oncology Studies

Rare Disease Recruitment: 5 Strategies for Differentiating Trials in a Competitive Research Environment

Ready to get started? So are we.

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