Medical Device Clinical Research Projects

PMI has been the CRO of choice for a variety of medical device clinical research projects for clients ranging from industry leaders to early-stage companies. The projects we have managed range from single site studies involving less than 100 subjects followed for one week to large, multi-center projects involving more than 1,000 subjects followed for 5+ years. The project objectives also vary — from performing the pivotal study of safety and effectiveness in support of a pre-market approval submission to FDA to providing data that can be used to support corporate marketing objectives.

Our involvement typically includes overall project management, clinical site management and monitoring, data management, biostatistics, medical writing, and regulatory submission support for devices associated with:

• Cataract and refractive surgery
• Glaucoma surgery
• Age-related macular degeneration
• Retinal tear management
• Non-surgical treatment of myopia and hyperopia
• Coronary artery occlusion
• Congestive heart failure
• Whole blood analysis
• Blood gas and chemistry monitoring
• Influenza diagnosis
• Orthopedic, spine and trauma surgery
• Cerebral arteriovenous malformation treatment
• Breast biopsies, reconstruction/augmentation
• Body countouring
• Facial toning

Procedural Familiarity and Program Efficiencies
At PMI, we understand that the design and implementation of medical device studies may be quite different from studies of pharmaceutical products. Our ISO-certified systems include plans, procedures and templates that can be readily customized for medical device projects. In addition, our staff is well-trained on CFR Part 812 requirements for medical device clinical study conduct and knowledgeable about operating suite activities and procedures. These assets allow us to rapidly develop comprehensive project plans and quickly assemble skilled, highly-rated project teams to partner with our clients for optimal success.

Broad Array of Services
PMI maintains an extensive network of globally-based industry resources, which allows us to provide client services ranging from early stage product development through clinical trials/product registration and on to commercialization, as well as to extend our geographic coverage beyond North America to the European Union and India.

For more details regarding our clinical expertise, please review our PMI Clinical Project Summary (PDF) or Contact Us to discuss your specific project.