Serving our partners.
Today’s healthcare environment is complex: Payers want proven “value.” Providers want solutions to make their practices effective and efficient. Patients are more and more involved in decision making. Regulators want bigger margins of patient protection. And investors want compelling evidence. A smart development partner is key to your success.
Fortrea supports the entire development journey for medical device and diagnostic companies, from first-in-human and early-phase trial design through regulatory approvals and market launch. Fortrea’s team of 150 specialists in clinical development of medical devices and diagnostic tools acts with urgency and agility to challenge the status quo and deliver with purpose. And, as with any high-performance team, an interactive relationship is the foundation by which we achieve greater results together.
Specialized approach.
Unlike other medical device and diagnostics CROs, our specialized approach means we look at your project with both clinical and strategic eyes and adeptly apply our interdisciplinary knowledge throughout the duration of the process. We ask “why?” first, remain focused on the end goal, and build on each project through:
- Feasibility and pivotal studies
- Analytical and clinical validation
- Human factor studies
- Regulatory consulting
- Commercialization and post-market support
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.