Diagnostics
The know-how to advance your diagnostic development
With Fortrea, you get a team that is dedicated to supporting your diagnostic trials, with deep experience around the globe.
Mastering the Diagnostics Journey: from Validation to Clinical Evidence
We work with your team to master every stage of the medical diagnostic development—working side-by-side with your team to plan and execute trials that accelerate regulatory readiness and generate compelling clinical evidence.
Global Diagnostic Specialism with Local Insight
Our global diagnostic dedicated team provides niche-level support with the regional fluency and operational continuity to eliminate cross-border complications
Minimizing Rework, Maximizing Trust
Our diagnostic specialists safeguard sample integrity with precision, minimizing rework,and ensuring quality results that withstand regulatory scrutiny
An integrated approach for your diagnostics
We work with you to support your diagnostic development. Our diagnostic professionals can help you design a pathway that meets your development and go-to-market objectives, ensuring a seamless flow of activities for a successful launch. Regulatory considerations are part of the plan, giving you the edge you need in your target therapy area. In addition to pre-market activities, once your product is on the market, we can help support your post-market regulatory requirements and study needs efficiently and cost-effectively.
Simplify your outsourcing needs with a single collaborator, from start to finish.
Together, exceptional diagnostics are possible.
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Clinical validation services
- Health Economics and Reimbursement
- Clinical Performance Studies
- Clinical Development Plans
- Diversity Plans
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Regulatory Support
- Regulatory Strategies
- Market Access Submissions
- Agency interactions
- Quality Systems
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Comprehensive patient safety and post-market support
- Patient Safety
- Post Market Clinical Follow Ups
- Post Market Surveillance Support
- FDA Adverse Event Reporting
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Full life cycle support
Once your product gains market approval, our team helps you navigate evolving market conditions, sustaining the success of your diagnostic. From training to compliance, audit preparation and recall management, we use our expertise across therapeutic areas to give you every conceivable market advantage.
Our commercial services include:
- New labeling claims and expanded folio
- Recall support
- Obsolescence planning and preparation
- Training program design and implementation
- Remediation programs
- System compliance
- Strategy reimbursement assessments
- Payer initiative and reimbursement strategies
- Payer insights and payer mix analysis
- Pricing
Precision Oncology
Fortrea’s precision oncology experts, part of our Diagnostic Center of Excellence provide the guidance and infrastructure you need to support your liquid biopsy trials.
Diagnostics-related frequently asked questions
Choose the level of oversight and accountability you need.
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What types of diagnostic products do you support?
We support a wide range of diagnostic technologies, including in vitro diagnostics (IVDs), companion diagnostics, point-of-care tests, molecular diagnostics, and digital health tools as well as imaging diagnostics.
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How do you help with regulatory submissions?
Our regulatory experts guide you through every step of the submission process, including strategy development, dossier preparation, and interactions with regulatory bodies like the FDA, EMA, and other global authorities.
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Do you have experience with EU IVDR and U.S. FDA regulations?
Yes, our team has deep expertise in both EU IVDR and U.S. FDA CFR Part 820 requirements, ensuring your product meets all necessary compliance standards for global market access.
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Can you assist with clinical trial design for diagnostics?
Absolutely. We specialize in designing efficient, evidence-driven clinical studies tailored to your diagnostic product’s unique needs, helping you generate the data required for regulatory approval/clearance and market success.
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What is your global reach and infrastructure?
We operate globally with strong footprints in the US, EU, and APAC regions. Our ISO 13485-certified infrastructure and local regulatory knowledge help streamline your path to market across multiple geographies.
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How do you ensure trial efficiency and cost-effectiveness?
We use an agile, high-impact approach to optimize protocols, reduce timelines, and manage resources effectively—without compromising data quality or regulatory compliance.
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What makes your diagnostic division different?
Our dedicated diagnostic team combines decades of experience with a flexible, client-centric approach. We tailor every engagement to your goals, ensuring strategic alignment and operational excellence.
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Can you support post-market surveillance and lifecycle management?
Yes, we offer comprehensive post-market services, including performance monitoring, regulatory updates, and support for product modifications or expansions.
Insights
Get the latest updates from our Diagnostics Team
Intensive Bioresearch Monitoring (BIMO) preparation is key to successful inspection results for sponsors and sites
Download Case Study
The importance of early integration of liquid biopsy to enhance oncology research
Download White Paper
Detecting the Undetectable: The Rising Potential of Liquid Biopsies in Oncology
In the past decade, a vial of blood has become a powerful window into cancer biology. Liquid biopsies, once limited to detecting specific mutations in advanced lung cancer, now offer a dynamic, real-time view of tumor genetics across multiple cancer types.
Read Detecting the Undetectable: The Rising Potential of Liquid Biopsies in Oncology