Human clinical data may be needed to support regulatory submissions, publications, or simply to advance knowledge of diseases and associated treatments. We can help you understand when clinical data may be necessary, determine exactly what kind of data will be most useful to meet your goals (e.g., FDA approval), and strategize solutions for collecting them most efficiently. In addition, we have significant experience executing the necessary clinical trials, ranging from small early feasibility studies to multinational, controlled pivotal trials to post-market registries.
Our personnel have managed clinical trials in a variety of disciplines, such as, but not limited to, interventional radiology/vascular surgery, wound care, soft tissue surgery, cardiology, urology, otolaryngology, head and neck surgery, rheumatology, endocrinology, and cell therapy. We have also designed feasibility trials for novel treatments of a variety of diseases, including, but not limited to, aortic aneurysms, aortic dissections, peripheral vascular disease and critical limb ischemia, chronic dry eye, ventral hernia, hiatal hernia, critical care, and chronic diabetic wounds.