FDA and EMA are requiring more evidence of pediatric safety and efficacy, adding new pressures to developing pediatric drugs.
Navigate the complex global regulatory environment and ensure that your drugs are delivered to children in need as quickly as possible.
You need a partner with extensive expertise in pediatric therapies. We’re here to provide insight and resources to help you not only meet regulatory requirements, but also execute pediatric clinical trials with confidence.Are pediatric drugs in your pipeline? Count on our specialized expertise to help you:
- Create the right plan – Whether it’s a Pediatric Development Plan or Pediatric Investigation Plan
- Analyze pediatric difference – Determine the best preclinical study design and strategy for ADME study (absorption, distribution, metabolism, excretion) in the pediatric population
- Streamline pediatric clinical trials – Our track record clinical trials for children ranges from pharmacokinetic studies to mega trials. Our investigator network represents every pediatric sub-specialty
- Overcome recruiting challenges – We have recruited and enrolled pediatric patients in challenging populations
- Expand regionally or globally – We’ve conducted pediatric clinical trials in 77+ countries.
- Capture outcomes – We ensure evidence-based strategies using data-driven tools and databases