The trial protocol is the blueprint for carrying out your trial. Writing an ineffective protocol will adversely affect your development timeline and will waste money. This is why MED Institute supports clients early in the clinical study design and trial protocol development stage. MED works in collaboration with experts and study stakeholders to determine reasonable performance goals, to determine appropriate examinations and procedures, and to define the right patient population to target via the trial eligibility (inclusion/exclusion) criteria. A well-written protocol is essential to maximize risk in gathering the necessary clinical data about your product.
Real-world experience, thoughtful guidance.
MED Institute is a full-service contract research organization (CRO) that provides engineering, regulatory, and clinical trial consulting services. We provide thoughtful guidance and quality clinical trial services to clients who require expertise in the efficient development of novel medical products and therapies.
Human clinical data may be needed to support regulatory submissions, publications, or simply to advance knowledge of diseases and associated treatments through investigative clinical research. 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 resulting clinical trials, ranging from small 5-patient feasibility studies to multinational, controlled pivotal trials to post-market registries.
Our personnel have managed clinical trials in a variety of disciplines, including 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 aortic aneurysms, aortic dissections, peripheral vascular disease and critical limb ischemia, chronic dry eye, ventral hernia, hiatal hernia, critical care, and chronic diabetic wounds.