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.

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.

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.

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.

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.

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.

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.

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.

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Expert

David Cooper

Chief Administrative Officer

David Cooper has served as Fortrea’s Chief Administrative Officer since May 2023, responsible for Human Resources, Procurement, Facilities and Corporate Communications.

Hematology

Work with the experts in the design, conduct and management of hematology trials—from early phase to registrational and post approval.

Diabetes & Endocrinology

Our endocrinology professionals leverage their extensive diabetes and lipid disorder experience to help you create streamlined solutions. Learn more here.

Inflammatory & Autoimmune

Discover Fortrea's research efforts in autoimmune diseases, focusing on developing effective treatments and improving patient care.

Dermatology

Fortrea's cutting-edge scientific and medical experts leverage global outreach to provide patient-centric clinical trials, astute counsel and enterprise-wide centers of excellence that yield true value in the form of transformative insights and applied market impact for dermatology studies.

Therapeutics

Discover how our therapeutic insights help deliver your life-changing solutions faster.

RWE & Post-Approval Studies

Fortrea has over 30 years of worldwide experience in the late phase industry. We have deep institutional expertise across all therapeutic areas, established investigator relationships and broad real-world insights. Learn more here.

Diagnostics

Fortrea offers in vitro diagnostic development and lab test solutions. Partner with us for advanced diagnostic testing and innovative lab development services.

Medical Devices

Our specialized medical device division within our global CRO offers consultation and support, providing essential insights and expertise to help you maximize your device’s potential.