Demonstrate greater safety and efficacy
Pediatric trials bring unique challenges. And enhanced scrutiny. The FDA and EMA are requiring more evidence of pediatric safety and efficacy, which can add new pressures to pediatric drug development. By understanding the stipulations and planning ahead to meet them, you can be more certain that your drugs will be delivered to children in need as quickly as possible.
Extensive expertise in pediatric therapies – and regulatory requirements
Quintiles has helped develop or commercialize 85% of 2013’s top 20 best selling pediatrics products or compounds. We can provide insight and resources to help you not only meet regulatory requirements, but also execute pediatric clinical trials with confidence.
Our specialized expertise enables you to:
- Create the right plan. 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. We’ve conducted more than 350 clinical trials for children, from pharmacokinetic studies to mega trials, and our investigator network represents every pediatric subspecialty.
- Overcome recruiting challenges. We’ve recruited and enrolled more than 228,000 pediatric patients, many in challenging populations.
- Expand regionally or globally. We’ve conducted pediatric clinical trials in more than 82 countries.
- Capture outcomes. We ensure evidence-based strategies using data-driven tools and databases.
We understand the unique safety and efficacy issues you face during pediatric drug development. Across hundreds of trials, we’ve contributed our therapeutic and regulatory expertise to support sponsors’ success.