Diagnostics
The know-how to advance your diagnostic development
Optimize your diagnostic and IVD development with our insightful expertise. Our integrated approach ensures analytical validity, clinical credibility and streamlined global regulatory compliance.
Optimize your development pathway
Confirm analytical validity and develop credible evidence for the clinical validity of your IVD.
Global regulatory expertise
Partner with experienced global regulatory experts to advance your diagnostic development.
Accelerate market readiness
Fast-track your diagnostic development with our comprehensive medical, scientific and regulatory expertise.
An integrated approach for your diagnostic
We work with you to support your diagnostic development. Our diagnostic professionals can help you to 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 in an efficient and cost-effective manner.
Simplify your outsourcing needs with a single partner, from start to finish.
Together, exceptional diagnostics are possible.
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Clinical validation services
- Feasibility studies
- Clinical strategy development (e.g., test methods)
- Study design
- Study operations
- Safety monitoring and management
- Data management
- Biostatistical analyses
- Clinical auditing
- Medical writing
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Expert regulatory support
Ensure your diagnostic or in vitro diagnostic (IVD) development program complies with all quality systems regulations, including the FDA’s Quality System Regulation, ISO 13485 and ISO 9001. Our proactive approach keeps you clear of sanctions, costly delays and limited market access
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Comprehensive patient safety and post-market support
Maintain confidence and security in your device review process. Our safety data specialists use highly standardized systems and AI capabilities, ensuring identification and reporting of root-cause challenges to keep your product compliant.
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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.
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
Future-Proofing SaMD: Regulatory Strategies for Medical Software Development
The rise of software as a medical device (SaMD) is transforming healthcare by enabling real-time data analysis, personalized care and predictive diagnostics.
Read Future-Proofing SaMD: Regulatory Strategies for Medical Software Development
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