{
"@context": "https://schema.org",
"@graph": [
{
"@type": "WebPage",
"@id": "https://www.fortrea.com/insights/accelerated-submission-rare-disease-fortrea-fsp-case-study#webpage",
"url": "https://www.fortrea.com/insights/accelerated-submission-rare-disease-fortrea-fsp-case-study",
"name": "Accelerated submission in rare disease clinical trials: Fortrea FSP case study",
"description": "This case study shows how functional service provider clinical trials supported a biotech sponsor in a rare disease program to deliver an accelerated BLA submission through scalable resourcing, strong regulatory execution, and consistent operational oversight. The engagement focused on providing experienced functional teams to manage key activities across clinical data, biostatistics, and submission workflows, including development of statistical analysis plans (SAPs) to support robust data interpretation and regulatory requirements. By integrating seamlessly with the sponsor’s internal teams, the FSP model enabled efficient coordination, reduced operational bottlenecks, and ensured continuity across critical submission tasks. The approach emphasized structured planning, clear communication, and reliable delivery to maintain compliance, data integrity, and quality under tight timelines. This case study highlights how a flexible FSP model can strengthen execution, improve efficiency, and support successful BLA submission outcomes in complex rare disease clinical development programs."
},
{
"@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": "Accelerated submission in rare disease clinical trials: Fortrea FSP case study",
"item": "https://www.fortrea.com/insights/accelerated-submission-rare-disease-fortrea-fsp-case-study"
}
]
},
{
"@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/accelerated-submission-rare-disease-fortrea-fsp-case-study#casestudy",
"mainEntityOfPage": {
"@id": "https://www.fortrea.com/insights/accelerated-submission-rare-disease-fortrea-fsp-case-study#webpage"
},
"headline": "FSP Clinical Trial Support and Accelerated BLA Submission Success in Biotech | Fortrea Insights",
"description": "This case study shows how functional service provider clinical trials supported a biotech sponsor in a rare disease program to deliver an accelerated BLA submission through scalable resourcing, strong regulatory execution, and consistent operational oversight. The engagement focused on providing experienced functional teams to manage key activities across clinical data, biostatistics, and submission workflows, including development of statistical analysis plans (SAPs) to support robust data interpretation and regulatory requirements. By integrating seamlessly with the sponsor’s internal teams, the FSP model enabled efficient coordination, reduced operational bottlenecks, and ensured continuity across critical submission tasks. The approach emphasized structured planning, clear communication, and reliable delivery to maintain compliance, data integrity, and quality under tight timelines. This case study highlights how a flexible FSP model can strengthen execution, improve efficiency, and support successful BLA submission outcomes in complex rare disease clinical development programs.",
"genre": "Case Study",
"image": {
"@type": "ImageObject",
"url": "https://www.fortrea.com/sites/default/files/2025-09/a-fortrea-fsp-case-study.jpg"
},
"author": {
"@type": "Organization",
"name": "Fortrea",
"url": "https://www.fortrea.com/"
},
"publisher": {
"@id": "https://www.fortrea.com/#organization"
},
"datePublished": "2025-09-05",
"dateModified": "2025-09-05",
"encoding": {
"@type": "MediaObject",
"contentUrl": "https://www.fortrea.com/sites/default/files/2025-09/a-fortrea-fsp-case-study.pdf",
"encodingFormat": "application/pdf"
}
}
]
}