Pediatrics Consortium
A passionate group of experts focused on children’s special needs
Children are among the most vulnerable populations participating in the clinical research enterprise. Consequently, the regulatory and ethical challenges involved are uniquely complex.
Because pediatric clinical trials are unique and present specific challenges, drug development for children requires careful design and execution by experts dedicated to pediatric research.
A global, multidisciplinary, centralized resource for experience and insight
We established our Pediatrics Consortium to provide you with direct access to our more than 30 years of experience in pediatric clinical and commercial drug development — including the specialized clinical and regulatory expertise required when working with vulnerable patient populations and their families.
Specialized, customized solutions
We embed Pediatric Consortium experts into all of our study teams, facilitating customized planning and sharing of operational and technical know-how to help you mitigate risks, navigate challenges, and facilitate regulatory approval and market access.
Our Consortium model ensures that our collective knowledge and insights are fully leveraged to deliver solutions specific to the needs of each trial.
Nuanced attention to protocol design
Pediatric protocols must be designed around patients and require careful execution, including an understanding of how different study designs, along with site selection, impact enrollment.
The Consortium includes highly-skilled medical, pharmacokinetic experts and biostatisticians to help select the most appropriate trial design, study endpoints and clinical trial assessments for the specific indication, study phase and age group.
Patient-centered recruitment and retention
Patient communications assume new layers of complexity in the pediatric setting — especially considering you are often “enrolling the family” in a clinical trial. These communications need to be customized to the very distinct motivations and needs of all concerned.
We have substantial expertise developing informed consent/asset documents specific to different pediatric age groups and social and regional differences. We have also developed therapeutically specific recruitment techniques that must not only accommodate the cognitive and social development of pediatric participants, but must also abide by local requirements on a global scale.
Ready to see how Syneos Health® can support you in every aspect of developing your pediatric asset?
Approximately 50 percent of rare diseases affect children, 30 percent of whom will not live to see their fifth birthday
At Syneos Health, helping companies develop rare disease therapies is something we take personally. It takes novel and integrated approaches, including early engagement of key stakeholders, to accelerate products to market and de-risk the development of critical patient therapies. Our Rare Disease Consortium helps speed new rare disease therapies to the children and families who are waiting.
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