Experience: Pediatrics

At The Forefront Of Pediatric Drug Development

Experience: Pediatrics

With the passing of the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act, and finally the FDASIA in 2012, and The Pediatric Regulation in Europe, appropriate labeling of medicine for children has increased, drug safety has improved and pediatric studies are becoming more routine in drug development overall.

Effectively managing pediatric clinical trials requires a whole new level of specialized clinical expertise, proficiency in dealing with specific regulatory requirements and experience working with vulnerable populations and their families. At Synteract, we are at the forefront of working with sponsors in pediatric drug development. We draw on a broad, global background in this specialty, with 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 organisations
  • 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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