In the age of technology, many organizations struggle with incorporating federal and billing regulations with electronic systems. This comprehensive guide takes the reader through the clinical research financial road map in a step-by-step fashion. It focuses on the financial feasibility of considering a clinical research study, incorporating the study into integrated systems, and managing patient and sponsor billing. The Clinical Research Finance Roadmap: A Comprehensive Guide to the Financial Aspects of Clinical Research provides an in-depth look at the applicable regulations, operational efficiencies and risk mitigation strategies through the implementation of a compliant Clinical Research Billing (CRB) program. Readers will learn how to leverage study and patient data to maintain and enhance a comprehensive and compliant CRB program. 

• Chapter 1: History of Clinical Research and Protecting Human Subjects
• Chapter 2: The Feasibility Assessment Phase: Deciding to Participate in Clinical Research Study With a Focus on Financial Feasibility
• Chapter 3: Creating a Medicare Coverage Analysis (MCA): A Step-By-Step Approach; Billing Regulation Review
• Chapter 4: Clinical Trial Budgets and the Hidden Costs
• Chapter 5: Negotiating a Clinical Trial Budget
• Chapter 6: Integrating with the Electronic Health Record – Creating a Billing Grid
• Chapter 7: Investigator and Study Team Preparedness – Training and Study Initiation
• Chapter 8: Patient Billing: Charge Review Process and Medical Documentation
• Chapter 9: Participant Remuneration
• Chapter 10: Study Revisions/Contract and Budget Amendments
• Chapter 11: Sponsor Billing: Payment Milestones
• Chapter 12: Study Close-Out: Reconciliation Processes and Ensuring All Payments Received
• Chapter 13: Leverage Data: Using Patient and Study Data to Manage Current and Future Studies

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