Pediatrics
Successfully supporting the road to pediatric indications
The current regulatory climate, and the need to meet Food and Drug Administration (FDA) and European Medicines Agency (EMEA) pediatric regulations, has increased the burden on manufacturers. You not only need to know current requirements, but you need to execute trials with confidence. We can help you navigate those challenges.
Staying at the forefront of regulatory guidance and requirements our thought leaders can guide you through:
- The development of a Pediatric Investigation Plan (PIP) or Pediatric Development Plan
- Recruitment and enrollment patients in challenging populations
- Determining the best pre-clinical study design to analyze pediatric difference
- The strategy to study the Absorption, Distribution, Metabolism, Excretion (ADME) of the Investigational Product in the pediatric population
Our worldwide teams with 6 pediatricians have the ability to mobilize resources in any geography. The pediatrics teams’ experience includes:
- Management of more than 200 pediatric trials ranging from pharmacokinetic studies to mega trials in 33 countries in the past 5 years
- Over 15 years in of trial experience in Latin America, and extensive experience in Asia and Eastern Europe
- Utilization of tools and databases to ensure evidence based strategies
Through an understanding of these issues and utilizing our network of investigators experienced in pediatric clinical trials representing all pediatric sub-specialties we can work with you to ensure a strategic approach to your pediatric indication.
Contact us to learn more.
