{
"@context": "https://schema.org",
"@graph": [
{
"@type": "WebPage",
"@id": "https://www.fortrea.com/insights/simplifying-and-accelerating-risk-identification-and-assessment-xcellerate-risk-based#webpage",
"url": "https://www.fortrea.com/insights/simplifying-and-accelerating-risk-identification-and-assessment-xcellerate-risk-based",
"name": "Simplifying and accelerating risk identification and assessment with Xcellerate Risk-Based Quality Management",
"description": "This Fortrea case study explores how a large biopharmaceutical sponsor evaluated Xcellerate® Risk-Based Quality Management (RBQM) to improve the efficiency and consistency of clinical trial risk identification and assessment processes across its portfolio. Traditional risk management activities often require study teams to manually review protocols, search templates, reconcile lessons learned, and identify potential risks across multiple functions, creating inefficiencies that can delay startup activities and introduce variability into risk management planning. To address these challenges, Fortrea assessed the value of Xcellerate® RBQM, an AI-enabled solution that uses natural language processing and machine learning to analyze protocols and related study documentation against Fortrea's risk knowledge base. The solution automatically surfaces relevant risks, identifies historically applicable risk patterns, generates rationale-based risk recommendations, and enables teams to incorporate selected risks directly into RBQM workflows for tracking, assignment, and management. By automating risk identification and supporting more consistent risk assessment, Xcellerate® RBQM helps sponsors proactively manage critical-to-quality risks, reduce manual effort, improve operational efficiency, and strengthen risk management strategies across the clinical trial lifecycle."
},
{
"@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": "Simplifying and accelerating risk identification and assessment with Xcellerate Risk-Based Quality Management",
"item": "https://www.fortrea.com/insights/simplifying-and-accelerating-risk-identification-and-assessment-xcellerate-risk-based"
}
]
},
{
"@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/simplifying-and-accelerating-risk-identification-and-assessment-xcellerate-risk-based#casestudy",
"mainEntityOfPage": {
"@id": "https://www.fortrea.com/insights/simplifying-and-accelerating-risk-identification-and-assessment-xcellerate-risk-based#webpage"
},
"headline": "Risk-Based Quality Management: Simplifying Clinical Trial Risk Identification and Assessment with Xcellerate® RBQM | Fortrea Case Study",
"description": "This Fortrea case study explores how a large biopharmaceutical sponsor evaluated Xcellerate® Risk-Based Quality Management (RBQM) to improve the efficiency and consistency of clinical trial risk identification and assessment processes across its portfolio. Traditional risk management activities often require study teams to manually review protocols, search templates, reconcile lessons learned, and identify potential risks across multiple functions, creating inefficiencies that can delay startup activities and introduce variability into risk management planning. To address these challenges, Fortrea assessed the value of Xcellerate® RBQM, an AI-enabled solution that uses natural language processing and machine learning to analyze protocols and related study documentation against Fortrea's risk knowledge base. The solution automatically surfaces relevant risks, identifies historically applicable risk patterns, generates rationale-based risk recommendations, and enables teams to incorporate selected risks directly into RBQM workflows for tracking, assignment, and management. By automating risk identification and supporting more consistent risk assessment, Xcellerate® RBQM helps sponsors proactively manage critical-to-quality risks, reduce manual effort, improve operational efficiency, and strengthen risk management strategies across the clinical trial lifecycle.",
"genre": "Case Study",
"image": {
"@type": "ImageObject",
"url": "https://www.fortrea.com/sites/default/files/2026-04/xcellerate-rbqm.jpg"
},
"author": {
"@type": "Organization",
"name": "Fortrea",
"url": "https://www.fortrea.com/"
},
"publisher": {
"@id": "https://www.fortrea.com/#organization"
},
"datePublished": "2026-04-06",
"dateModified": "2026-04-06",
"encoding": {
"@type": "MediaObject",
"contentUrl": "https://www.fortrea.com/sites/default/files/2026-04/xcellerate-central-monitoring-medical-review.pdf",
"encodingFormat": "application/pdf"
}
}
]
}