{
"@context": "https://schema.org",
"@graph": [
{
"@type": "WebPage",
"@id": "https://www.fortrea.com/insights/practical-considerations-cell-and-gene-therapy-trials-neonates-and-young-children-living-0#webpage",
"url": "https://www.fortrea.com/insights/practical-considerations-cell-and-gene-therapy-trials-neonates-and-young-children-living-0",
"name": "Practical considerations for cell and gene therapy trials in neonates and young children living with rare diseases",
"description": "Explore this Fortrea white paper on clinical trial strategies for neonates and young children living with rare diseases and discover how specialized pediatric clinical development approaches are helping improve research in vulnerable patient populations. The white paper examines key considerations in pediatric rare disease clinical trials, including neonatal safety monitoring, ethical trial execution, caregiver engagement, patient recruitment challenges, age-appropriate endpoint development, and operational planning for studies involving neonates and young children. Learn how family-centered research strategies, specialized pediatric trial infrastructure, developmental assessments, translational pediatric medicine, and patient-centric operational models can help improve trial accessibility, support regulatory planning, reduce burden on families, and strengthen the successful execution of rare disease clinical research programs in neonatal and pediatric populations."
},
{
"@type": "BreadcrumbList",
"itemListElement": [
{
"@type": "ListItem",
"position": 1,
"name": "Home",
"item": "https://www.fortrea.com"
},
{
"@type": "ListItem",
"position": 2,
"name": "Insights",
"item": "https://www.fortrea.com/insights/"
},
{
"@type": "ListItem",
"position": 3,
"name": "Practical considerations for cell and gene therapy trials in neonates and young children living with rare diseases",
"item": "https://www.fortrea.com/insights/practical-considerations-cell-and-gene-therapy-trials-neonates-and-young-children-living-0"
}
]
},
{
"@type": "Organization",
"@id": "https://www.fortrea.com/#organization",
"name": "Fortrea",
"url": "https://www.fortrea.com",
"description": "Fortrea is a global contract research organization built on more than 30 years of experience and one of the earliest CRO legacies in the industry—as Covance, evolving within Labcorp, and now operating as Fortrea. With deep expertise across Phase I–IV clinical trials, Fortrea advances clinical research through a patient-centric approach that prioritizes meaningful outcomes, stronger site–CRO relationships, and operational excellence. Fortrea partners with biopharmaceutical, biotech, and medical device companies to advance therapies through every stage of clinical development. This commitment is further reinforced by the launch of Fortrea Intelligent Technology, enabling smarter, more connected, and data-driven clinical development. Through Fortrea Intelligent Technology, the organization is advancing data-driven, technology-enabled clinical development to improve speed, quality, and patient outcomes. It is shaped by experience, innovation, and a commitment to raising standards in clinical research—focused on accelerating development and helping bring life-changing treatments to patients around the world.",
"logo": "https://www.fortrea.com/sites/default/files/2025-05/fortrea-logo-without-background.png",
"sameAs": [
"https://www.linkedin.com/company/fortrea",
"https://www.threads.net/@fortreacro",
"https://twitter.com/fortrea",
"https://www.youtube.com/@Fortrea/",
"https://www.facebook.com/Fortrea-104143099267108",
"https://www.instagram.com/fortreacro"
]
},
{
"@type": "Article",
"@id": "https://www.fortrea.com/insights/practical-considerations-cell-and-gene-therapy-trials-neonates-and-young-children-living-0#whitepaper",
"mainEntityOfPage": {
"@id": "https://www.fortrea.com/insights/practical-considerations-cell-and-gene-therapy-trials-neonates-and-young-children-living-0#webpage"
},
"headline": "Clinical Trial Strategies for Neonates & Young Children Living With Rare Diseases | Fortrea White Paper",
"description": "Explore this Fortrea white paper on clinical trial strategies for neonates and young children living with rare diseases and discover how specialized pediatric clinical development approaches are helping improve research in vulnerable patient populations. The white paper examines key considerations in pediatric rare disease clinical trials, including neonatal safety monitoring, ethical trial execution, caregiver engagement, patient recruitment challenges, age-appropriate endpoint development, and operational planning for studies involving neonates and young children. Learn how family-centered research strategies, specialized pediatric trial infrastructure, developmental assessments, translational pediatric medicine, and patient-centric operational models can help improve trial accessibility, support regulatory planning, reduce burden on families, and strengthen the successful execution of rare disease clinical research programs in neonatal and pediatric populations.",
"genre": "White Paper",
"image": {
"@type": "ImageObject",
"url": "https://www.fortrea.com/sites/default/files/2025-05/fortrea-logo-without-background.png"
},
"author": {
"@type": "Organization",
"name": "Fortrea",
"url": "https://www.fortrea.com/"
},
"publisher": {
"@id": "https://www.fortrea.com/#organization"
},
"datePublished": "2025-11-26",
"dateModified": "2025-11-26",
"encoding": {
"@type": "MediaObject",
"contentUrl": "https://www.fortrea.com/sites/default/files/2025-11/cgt-trials-neonates-rare-diseases.pdf",
"encodingFormat": "application/pdf"
}
}
]
}