Site Challenges in Conducting Investigational Device Trials

Why Should You Attend:

Both sponsors who undertake clinical trials with investigational devices and the institutions that host them take on obligations and risks that are unlike those related to investigational drug studies. To proceed without an in depth knowledge of these matters can expose institutions, investigators and sponsors to risks that can easily be managed with a good understanding of the issues.

The regulations governing Investigational Device (IDE) studies are distinct in many respects from those governing investigational drug (IND) studies. Likewise, the processes created to carry them out are distinct and require and a good understanding of those differences is essential to compliant and successful studies.

This session will offer an overview of where the regulations diverge and how this impacts the design and execution of device studies. Additional issues related to device studies, such as Medicare approval and reimbursement, billing and coding and other areas of risk will be discussed. This course is recommended for both those experienced in device studies and those just now entering the field.

Learning Objectives:

At the end of this session, attendees will be able to:

• Recount the principal differences in the regulations governing investigational devices vs. drugs.
• Identify the risks peculiar to device studies.
• Address contract and budget challenges in IDE studies.
• Devise a system to manage the pricing, charging and billing of investigational devices in compliance with Federal rules and regulations.

Areas Covered in the Seminar:

• Device and Drug Regulations; the differences.
• The risks peculiar to device studies.
• Budgets and contracts for device studies- how they differ.
• Contract and Budget hot spots.
• Executing device studies; the nuts and bolts.
• Managing pricing, charging and billing for investigational devices; how to stay out of trouble.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel involved in the research enterprise, including:

• Sponsors
• Research Institutional Leaders
• Research Compliance professionals
• Clinical Research Professionals
• Billing/coding professionals

Instructor Profile:

Bob Romanchuk, is a clinical research professional with over a decade of experience in a broad range of clinical research infrastructure building, operation and management of both IRBs and research programs. This includes assembling and managing an IRB, building a cardiovascular research center for a large community hospital and creation and operation of a central research office for a 13 hospital system across North Carolina, South Carolina and Virginia. His certifications include CIP (Certified IRB Professional), CHRC (Certification in Health Research Compliance), CCRC (Certified Clinical Research Coordinator) and CCRCP (Certified Clinical Research Contract Professional). He has presented numerous times nationally on the subjects of clinical trial billing, human subjects protections and the creation and operation of centralized research offices.

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