VitaMedical LLC supports clients in a variety of strategic and tactical capacities within the disciplines of medical device clinical affairs, regulatory affairs, health economics, reimbursement, and quality systems throughout the product life cycle. Strategic support may include serving as functional representatives on medical device development teams and delivering strategies for evidence development, publication, regulatory approvals, clinical guideline development, health economics, health technology assessments, purchasing committee value assessments, and/or reimbursement pathways for major payer groups. Additionally, we support businesses with market access planning and pre-acquisition due diligence. We also provide tactical support in the areas of risk management activities, health hazard evaluations, literature reviews and narrative summaries, regulatory and clinical writing (submissions, clinical evaluation plans and reports, post market clinical follow-up plans and reports), clinical protocol and case report form development, clinical database design, clinical study plan development (statistical analysis, monitoring, data management, operations manual), clinical operations (data review/analysis/trending, monitoring, budget and staff management), clinical marketing material development, basic statistics, publications support, budget impact modeling, and value dossier development. We also provide associated policy and procedure development support. Additionally, we provide clinical evidence training, support tools, and account support for sales teams learning to use clinical evidence in the field. We also support physician-initiated research in areas of study design, protocol and case report form development, data review/analysis/illustration, publication planning, and draft abstract/poster/manuscript development. Let us bring to your company our cross-functional experience for innovating in modern healthcare systems. *Contact: kimberlyknish@hotmail.com*
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