What We Do
Strategy & Planning
We provide independent, expert advice and guidance to sponsors and others, to help them develop pediatric plans and protocols – doing our best to get them “right the first time”. The core components of what we do are:
- Facilitating the identification of unmet therapeutic needs of children
- Advancing scientific knowledge about best practices and strategies to close gaps in diseases and conditions that affect children
- Mobilizing stakeholders into action-planning to address important clinical trial design challenges
Capabilities, Tools & Best Practices
We lead and participate in cross-sector teams that streamline and improve clinical trial processes and systems to enhance the quality and timeliness of regulatory-quality data and reduce administrative burden. Education and training regarding standardized approaches and tools, particularly in those administrative areas that cause the most significant delays, are important outcomes of this work.
Infrastructure & Clinical Trial Execution
We support and manage a network of pre-qualified trial-ready sites and collaborate with regional and disease-focused networks to ensure that we reach children across the world.
We catalyze efforts that:
- Assure early and continuous engagement of patients, caregivers, investigators, nurses, pharmacists and other research delivery staff
- Create awareness and disseminate information and research regarding unique opportunities to address diseases and conditions that impact children
- Enhance the application of innovative trial designs and quantitative science research methods
- Improve clinical trial design and streamline trial conduct for all stakeholders
Collectively, these activities build the foundation for a pediatric clinical research system that is collaborative and sustainable. It is driven by scientific merit, produces clinically relevant medicines and devices, embraces the highest ethical standards and inspires others to support innovative clinical research for children.