ADVANCING LIFE-CHANGING OPTIONS

Medical Device and Diagnostic Development Solutions

Partners from first-in-human trials to commercialization

Leverage 150 specialists in device and diagnostic trials

Deploy traditional, decentralized and hybrid trial designs

Foresight and expertise.

A lot needs to happen to get a great idea to market. Devices need feasibility and pivotal studies, diagnostics require analytical and clinical validation. These need to happen as effectively, safely, economically and urgently as possible. Fortrea is your source to help you bring your product from concept through development, from testing through regulatory approval with reliable data and documentation along the way. From traditional to decentralized to hybrid trials, rest assured you will experience an expertly executed clinical development program.

Keeping the end in mind.

Once you receive approval to advance your device to the clinical stage, you will have many new questions to address, such as:

What are the right endpoints to collect and report to best support the objectives of my trial?
How can I identify and qualify preferred sites to ensure enrollment and study compliance success?
What is the best patient population and how can I motivate patients to participate in my trial?

We listen to your product and business goals and tap into our experience conducting more than 600 global studies in the last 5 years. We help you to uncover opportunities to reduce costs and improve timelines. From simple modifications of market-released products to novel combination products, our deep experience and proven integrated approach helps remove obstacles to expedite approvals with major regulatory agencies and notified bodies around the globe.

From the start, we will partner with you in a truly collaborative way. We will work side-by-side with you to move your product development forward towards commercialization and will help you to keep your product on the market.

Full-spectrum support.

With services spanning the entire continuum of device and diagnostic development and commercialization, Fortrea resources include:

Global clinical trial execution
Biocompatibility and safety testing
Regulatory consultation
Health economics and reimbursement consultation
Quality system consultation
Post-market study development and execution

Our ultimate goal is to be the strategic partner that helps innovators, such as you, bring important medical advancements to people all over the globe. Fortrea delivers value to meet the demands of a challenging and ever-changing market.

Your needs. Our solutions.

As a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions and other enabling services, Fortrea partners with emerging and large biopharma and medical device and diagnostic companies to drive healthcare innovation throughout the world.