The Clinical Research Finance Roadmap: A Comprehensive Guide to the Financial Aspects of Clinical Research

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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