Specialized regulatory expertise
Pediatric clinical trials require a team that understands the inherent challenges of working with this special patient population. The FDA and EMA require evidence of pediatric safety and efficacy, placing additional pressures on drug development programs and requiring a partner skilled at addressing these regulatory obligations. By understanding regulatory expectations 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, as safely as possible. Additionally, you may be able to benefit from exclusivity incentives.
Extensive expertise in pediatric therapies
Quintiles has helped develop pediatric products or compounds across a wide variety of therapeutic areas through all phases of clinical development. 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.
- Streamline pediatric clinical trials. Since 2010, we’ve conducted more than 460 clinical trials including children, from pharmacokinetic and rare disease studies to large vaccine trials and post authorization safety study registries, and our investigator network represents every pediatric subspecialty.
- Overcome recruiting challenges. Since 2010, we’ve recruited and enrolled more than 228,000 pediatric patients, many in challenging populations.
- Expand regionally or globally. Global reach - we’ve conducted pediatric clinical trials in 110 countries worldwide.
- Focused approach. We work with advocacy groups and network relationships to facilitate collaboration and shared insights.
- Capture outcomes. We ensure evidence-based strategies using data-driven tools and databases to create or adapt outcome measures.
- Pediatric Center of Excellence. A core group of medical, regulatory strategy, and operational experts dedicated to promoting and developing key insights, solutions, and best practices related to pediatric clinical trials.
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. Contact us to learn more or request a proposal to accelerate your pediatric clinical development.