Medical Device and Diagnostics
Specialized support to accelerate clinical development and commercialization
Medical device and diagnostics research is a broad and increasingly complex area requiring specialized expertise. Our focused group of medical device and diagnostics (MD&D) experts offer a full breadth of MD&D-specific capabilities that span the entire nonclinical and clinical development, regulatory, medical affairs and commercial continuum to strategically accelerate the product development lifecycle.
Medtech clinical trial solutions tailored to your requirements
As a medical device CRO, we thrive on collaboration. Together, we will review your plan, take the time to understand your goals, and aim to develop the most cost- and time-efficient development strategy to meet clinical, regulatory, and market adoption requirements.
Whatever your needs, we will work with you to adopt new processes and technologies, leverage our diverse therapeutic expertise, and access commercial insights. The goal? Facilitating shorter and more efficient clinical trials designed to improve the likelihood of regulatory and commercial success.
Strategy driven by a clear view of the regulatory landscape
Our customized clinical development solutions are paired hand-in-hand with bespoke regulatory solutions.
Our boutique MD&D CRO team has global muscle: our Global Regulatory Affairs Solutions (GRAS) experts provide full-spectrum, end-to-end solutions to biopharmaceutical, medical device, in vitro diagnostic (IVD) and combination product companies worldwide.
Our GRAS experts will lead you through important regulatory activities related to discovery, surveying the regulatory landscape, strategic planning, clinical investigation submissions, regulatory authorization submissions, maintenance, post-marketing requirements and compliance.
Our GRAS experts are located in regional centers of excellence in North America, Europe and Asia-Pacific, offering timely regulatory advice for every stage of your product’s lifecycle.
