Budgeting for Clinical Trials: Costs of a Study and Which Costs Sponsors are Responsible to Cover

Why Should You Attend:

Determining an appropriate clinical trial budget to ensure a study can be completed is challenging for both sites and sponsors. Whether you are new to clinical research, or have years of experience, there are 3 areas of expertise you may not have mastered - understanding and outlining costs, negotiating budgets, and complying with criteria (Medicare provisions for determining Qualifying Trials and Routine Care). If not, you may be a site that is underwriting sponsors costs, or you may be a sponsor that is overpaying site costs, and both sites and sponsors may be incorrectly submitting non-qualifying costs to insurers.

This webinar is intended to provide comprehensive terms of expenses and steps for evaluating costs; tips for negotiating budgets; and key information on determining qualifying trials and routine care. In addition to learning how to create complete and detailed cost plans and learning all terms are in fact negotiable, learn how to protect clinical research billing by keeping it compliant. The instructor’s extensive knowledge and experience in ensuring appropriate clinical trial billing to third party insurers (including federal, state and private) makes her well suited to answer your questions and offer best practice guidance to avoid errors in billing.

Learning Objectives:

At the end of this webinar, participants will understand categories of study costs and be able to identity costs that sponsors are expected to cover.

Areas Covered in the Webinar:

• Start-Up Costs.
• Fixed Costs.
• Variable Costs.
• Hidden Costs.
• Overhead.
• Qualifying Trials and Routine Care.
• Developing a Cost Plan.
• Negotiating a Budget.

Who Will Benefit:

This webinar will provide content and cover topics relevant to:

• Investigators
• Coordinators
• Contract/Budget Negotiators
• Health System Administrators
• Clinical Research Billing Compliance Staff/ Officers

Jennifer Holcomb
Director, Clinical Research Support Office, Duke University

Jennifer Holcomb,MA, CCRC, is a clinical research professional with 20 years of experience in the field. Currently employed by UCHealth, she provides guidance and leadership in the establishment and development of policies in the conduct and management of clinical research. Key areas of expertise include clinical trial budgeting and contract negotiations as well as regulatory knowledge including international ICH GCP standards. Jennifer has extensive experience in training and education and served as Vice Chair of the ACRP Professional Development Committee for 4 years ending in December 2013.

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