Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance
Duration : 60 Minutes
Marina Malikova, Executive Director, Boston University School of Medic
Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics an Read more
This webinar will discuss good clinical practice core principles and project management strategies applicable to financial aspects of clinical research during new biomedical product development process. Strategies and best practices to mitigate fiscal risks in clinical trials will be discussed i.e. coverage analysis, cost estimation, budgeting and billing Compliance.
Course Objectives:
This session is focused on processes and approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials. The ability to develop robust budgets, ensure billing compliance and adherence to CMS regulations for clinical trials remains a challenge for many clinical sites, sponsors and contract research organizations (CROs) . Lack of fiscal forecasting and unspecified billing compliance practices associated with clinical trials increases the risks of fiscal audits. A risk- based approach requires not only a strategy but tools to define key indicators to measure specific risks. This session is focused on strategies for covering true costs related to clinical research and distinguishing them from routine care charges, and providing methodologies to avoid false claims and/or wrongful billing.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• 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
• Grant Administrators
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
