Through vast expertise in preclinical models and human disease, CVPath has a recognized research team that offers study design consultation and small-scale device testing in vascular restenosis models from feasibility through GLP compliant regulatory submission. In-house preclinical models include small animals, such as rabbits and swine coronary & peripheral models, with acute and chronic study capabilities. Our services include biocompatibility and safety in addition to pharmacokinetic testing for the drug component. Whether your company is a startup or an established industry leader, CVPath is uniquely qualified to support the success of your device design.
Trial Design, Development, and Support
CVPath Institute partners with the medical technology industry on device design and evaluation. This partnership begins as early as the bench-level prototyping phase to preclinical research models with CVPath Institute addressing critical questions of feasibility, biocompatibility, and GLP safety.
Based on our deep expertise of human disease and superior scientific inquiry methods, we can assist our industry partners with developing preclinical research plans and regulatory consultation for investigational device 510K and IDE approvals. Our industry partners have embraced this consultation service given the current uncertain regulatory environment for medical device commercial approval.
In providing trial design, development, and support services, CVPath Institute manages study integrity, compliance, and oversees data integrity & final reports as part of our Quality Assurance (QA) program. Our QA program follows FDA Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies.