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Coverage Analysis, Cost Estimation and Budgeting in Clinical Research

Summary

  • Budgeting in clinical research

  • Learn how to perform Medicare Coverage Analysis

  • Define studies qualified for insurance reimbursement for experimental drugs and devices

  • Review device classification and applicable categories of devices for insurance reimbursement within clinical trial

  • Review different charges in clinical research (research –related versus routine care, “billable to insurance)

  • Fiscal forecasting

  • Financial management on clinical research

  • Fiscal and billing compliance risk mitigation strategies

Overview

This webinar is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles and project management strategies applicable to financial aspects of clinical research during new biomedical product development process.

Who should attend?

  • New Project Managers
  • Project Managers with little or no drug development or clinical trial experience
  • Staff from Pharmaceutical Companies or Contract Research Organizations (CROs) involved with the management of clinical trials
  • New Clinical or other Project Team Leaders who will be managing projects
  • Managers unfamiliar with clinical project management
  • New Clinical, Regulatory, and Department Staff who will design clinical trial programs
  • Clinical Research Associates, Data Managers or others interested in transitioning into clinical trial management
  • Project Team Leaders with limited direct clinical trial experience who will be managing drug development programs and supervising project managers

Marina Malikova

Expert

Dr. Malikova has over 15 years of experience in the clinical research field.  She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products.  She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

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