Event Calendar

Finance and Billing

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2018 Agenda

2019 Agenda Coming Soon! 

Saturday, September 29, 8:30 to 9:15                                      

Effective Management of Clinical Trial Finances 

Ms. Sarafin will discuss how to create and negotiate a comprehensive clinical trial budget, then move to best practices for daily financial management of clinical trials. How to work with your clinical team to track activity and invoiceables, renegotiate when needed, and ensure full payment from sponsors will be presented. 417

Presenter: Sandra Sarafin, BA, CCRP, Director, Research Finance Office, Ohio State University

Track: Finance and Billing

Saturday, September 29, 9:20 to 10:05                                    

Financial Management of a Clinical Trial at an Academic Institution: Lessons Learned 

This presentation will include discussion points related to a centralized clinical trial finance management department at an academic institution.  Points to be covered will include; the department’s organizational structure, electronic systems utilized, collaboration with clinical and other research administration departments, challenges/successes, and lessons learned since the department originated. 419

Presenter: Veronica Kain, MBA, Director, Clinical Trials Financial Management, Children's Hospital of Philadelphia 

Track: Finance and Billing

Saturday, September 29, 10:50 to 11:35                                  

Leveraging CTMS and EHR to Build a Compliant Research Billing Program 

Attendees will learn the essential elements of building a compliant research billing program and will understand foundational elements of a research billing program. The session will provide attendees with helpful tools, techniques and resources to establish a research billing program. 421

Presenter: James Luca, MS, MBA, CHRC, CHC, Program Manager, Clinical Research Finance, The University of Texas MD Anderson Cancer Center 

Track: Finance and Billing

Saturday, September 29, 11:40 to 12:25                                  

Financial Planning and Management of Study Coordinator Time on Clinical Trials 

How do you successfully use variable funding to support the coordinator’s fixed effort cost? It’s challenging but can be done! Ms. Goldfarb will discuss strategies to successfully manage clinical research staff time and effort in order to maximize recovery of true costs. This discussion will focus on processes and best practices for evaluating new studies, creating accurate budgets, creating a project plan with the final budget, and proactively managing staff time and effort throughout the clinical trial lifecycle. We will also review common challenges related to the ambiguities and complexities associated with clinical trials and propose solutions that will support positive operational and financial outcomes. 423

Presenter: Jennifer Goldfarb, MSN, RN, CCRP, Data Monitoring Committee Lead, ACI Clinical 

Track: Finance and Billing 

Saturday, September 29, 1:40 to 2:25                                  

Increase Revenue By Billing Compliantly 

This session will provide a broad overview of clinical trail billing compliance. Ms. Willenberg will review cycle integrity and research administration to increase your research brand. 425 

Presenter: Kelly M. Willenberg, DBA, RN, CHRC, CHC, CCRP, CEO, Kelly Willenberg LLC   

 Track: Finance and Billing 

Saturday, September 29, 2:30 to 3:15                                

Charging Patients for Costs Associated with Clinical Trials and Expanded Access Uses: Understanding FDA Limitations and Requirements 

FDA regulations impose strict limits on the circumstances in which a researcher can recover costs from a patient, as well as the types of costs that can be recovered. In addition, prior written authorization from FDA must be obtained for any cost recovery. Ms. Backfield will help researchers understand the key standards and procedures for patient cost recovery in the context of both clinical trials and expanded access usage. 427

Presenter: Katlin Backfield, JD, Attorney and Consultant, Backfield PLLC   

Track: Finance and Billing