At The Forefront Of Pediatric Drug Development


We have performed, over our history:

  • 95+  Clinical Trials
  • 17 Indications
  • 1,395 Sites
  • 24,100 Patients

There is a definitive, growing need for medications designed specifically for children. Pediatric development plans have become a requirement for new drugs in the US and EU and pediatric clinical research is on the rise. Recruitment, ethical, scientific and logistical challenges pose specific needs in studies aimed at children.

At Synteract, we understand pediatric development is special. We are at the forefront of working with sponsors in pediatric drug development, having conducted 95+ pediatric clinical trials, globally, with nine running in 2018 alone. Our pediatric cross-functional team helps our clients navigate through the complexity of pediatric research and provides tailored pediatric development planning and experienced technical and operational services to allow medicines to reach patients in need.

We understand the level of compassionate and specialized clinical and regulatory expertise required in working with vulnerable pediatric populations and their families. We have experience working with international pediatric networks, opinion leaders, with patient advocacy groups and regulatory bodies that are key to pediatric development and pediatric success, and capitalize on relationships with global partners invested in this patient population.

Broad-based Pediatrics Experience:

Pediatrics Pie Chart
  • A - Respiratory: 16%
  • B - Endocrinology: 14%
  • C - Gastroenterology: 10%
  • D - Infectious Disease: 10%
  • E - Hematology: 9%
  • F - Dermatology: 7%
  • G - Metabolic: 7%
  • H - Dental: 5%
  • I - Neurology: 4%
  • J - Nutrition: 3%
  • K - Oncology: 3%
  • L - Cardiology: 2%
  • M - Ophthalmology: 2%
  • N - Psychiatry: 1%
  • O - Cosmetic: 1%

We have conducted pediatric studies in oncology, hematology, infectious disease, metabolic disease, respiratory, gastroenterology, nutrition, rare and orphan diseases, and numerous other therapeutic areas across 6 continents in 62 countries.

We can assist with all aspects of pediatric drug development and provide you with solutions for your pediatric development including medical and regulatory strategy; trial design considerations; creation, submission, follow-up and updates of PSPs and PIPs; and the benefit of strong relationships with pediatric networks, patient organizations, and Young Advisory groups.

Our clinical experts can guide you through evolving global regulations and data requirements each step of the way. Many of our executives are actively involved in the industry.


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