Notable Experience:

PEDIATRIC CLINIAL TRIALS & STUDIES

At The Forefront Of Pediatric Drug Development

Notable Experience:

PEDIATRIC CLINIAL TRIALS & STUDIES

At Synteract, we are at the forefront of working with sponsors in pediatric drug development having conducted 100 pediatric clinical trials, globally.  Our team understands the level of specialized clinical and regulatory expertise required in working with vulnerable pediatric populations and their families.

Synteract has conducted pediatric studies in oncology, respiratory, infectious diseases and rare diseases and numerous other therapeutic areas, conducted across 6 continents, in 60+ countries.

We can assist you with all aspects of pediatric drug development:

  • Medical and regulatory strategy
  • Considerations for trial design
  • Creation of Pediatric Study Plans (PSPs) and Pediatric Investigational Plans (PIPs). Plan(s) submission, follow-up and maintenance
  • Liaison and meetings with authorities
  • Feasibility assessments
  • Ethical codes of conduct
  • Site selection and patient recruitment support
  • Relationship with pediatric networks and patient organizations
  • Data monitoring
  • Safety services

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, including our Vice President, Global Medical and Regulatory Affairs, who also serves as chair of the EUCROF Pediatric Working Group, chair of the European Forum for Good Clinical Practice Children's Medicines Working Party and a member of the Enpr-EMA working groups, European Network of Pediatric Research at EMA.

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