Event Calendar

Agenda

Advanced Site Management: Finance and Productivity Enhanced Business Practices for Clinical Research Programs

For a printable PDF agenda, click here.
Day One - Thursday

8:15 - 8:45 Registration and Continental Breakfast

8:45 - 9:15 Introductions and Orientation
Jim Simmer, BSN, MBA, President, Research Answers
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare

Mr. Simmer and Mr. Snyder will discuss the essence of financial and productivity issues involved in site management.

9:15 - 10:00 Clinical Research Industry - Why Can’t We Just Get Along?
Jim Simmer, BSN, MBA, President, Research Answers

Mr. Simmer will discuss the state of the clinical research industry. Topics include growth of the clinical research industry, economic pressures between research sites and sponsors, and a discussion of new research opportunities for advanced sites.

10:00 - 10:15 Break

10:15 - 11:45 Research Site Business Foundation
Jim Simmer, BSN, MBA, President, Research Answers

Mr. Simmer will lead a discussion that covers the foundational principles required to build a profitable research site. This lecture will address the structure of profitable sites, study pipelines, subject recruitment, and site productivity measurements.

11:45 - 12:45 Lunch (Provided)

12:45 - 1:30 Clinical Research Billing Compliance
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare

Mr. Snyder will conduct a review of many significant concerns related to managing the billing compliance of research studies. This presentation will include a review of the relevant CMS billing regulations for clinical billing services in research studies. This lecture will also provide participants with tools to assist in making the right decisions and implementing billing systems for research programs.

1:30 - 1:45 Interactive Demonstration - Conduct a Billing Analysis
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare

Mr. Snyder will request the assistance of an attendee volunteer and conduct a billing analysis on a research protocol. This session will conclude with each participant taking home a customized billing tool.

1:45 - 2:30 Clinical Trial Budget Development
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare

Mr. Snyder will explain the systems used by sponsors to develop study budgets and the methods used by sites to assess these financial proposals. This lecture will explain the reasons sponsors and sites experience frequent conflict related to budget issues and provide techniques for managing the process.

2:30 - 2:45 Break

2:45 - 3:30 Clinical Trial Budget Analysis and Negotiation
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare

This presentation will include detailed instructions for reviewing and negotiating a study budget. This lecture will include a demonstration of tools that can be used to develop a clear and transparent budget analysis.

3:30 - 4:00 Interactive Demonstration – Conduct a Budget Analysis
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare

Mr. Snyder will request the assistance of an attendee volunteer to complete a cost analysis on a research protocol in order to introduce an additional perspective. This session will conclude with each participant taking home a customized budget analysis.

4:00 - 4:15 Role Playing – Negotiate a Clinical Trial Budget
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare
Jim Simmer, BSN, MBA, President, Research Answers

The instructors and participants will role play the processes involved in negotiating a clinical research budget.

4:15 - 4:45 Question & Answer Session/ Discussion

Day Two - Friday

8:30-9:00 Continental Breakfast

9:00-9:30 Clinical Research Revenue Recognition
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare

Mr. Snyder will begin the presentation with a review of the types of research revenue. This presentation will include a demonstration of revenue recognition models and tools.

9:30-10:30 Research Expense Management
Jim Simmer, BSN, MBA, President, Research Answers

Mr. Simmer will illustrate the challenges faced in managing expenses at a clinical research site. This presentation will include methods of defining research expenses, tracking research costs and controlling total expenses.

10:30-10:45 Break

10:45-11:15 Research Accounts Receivable Management
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare

Mr. Snyder will provide a method of assessing your study performance and revenue position. This lecture will show participants how to manage their research program accounts receivable and business office reporting requirements.

11:15-11:45 Research Collections
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare

Mr. Snyder will demonstrate a detailed process for managing the research collections process and enhancing cash flow at the research site.

11:45-12:45 Lunch (Provided)

12:45-1:15 Clinical Research Current Events and Hot Topics
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare
Jim Simmer, BSN, MBA, President, Research Answers

The speakers will discuss current events and hot topics that are impacting clinical research finance and budgeting. This discussion will focus on Subject inquiry, the Sunshine Act, indemnification, and risk based monitoring.

1:15-1:45 Financial tracking using Excel
Jim Simmer, BSN, MBA, President, Research Answers

This module will compare and contrast Microsoft Excel software capabilities with generally available functionality available in a Clinical Trials Management System. Participants will learn how to use excel formulas to manage financial aspects of trials, to invoice sponsors, and to link spreadsheets to create reports.

1:45-2:45 Research Program Profitability
Andrew Snyder, MBA, FACMPE, PMP, Director of Operations and Research, HealthEast HeartCare

Mr. Snyder will demonstrate methods of calculating the profitability of a clinical research program in various organizations. This lecture will include a review of research specific profit and loss reporting and profitability forecasting for your research team.

2:45-3:00 Break

3:00-3:30 Interactive Demonstration - Conduct a Research Site Pro Forma
Mr. Snyder will present a real-world scenario in which a site professional must forecast a research site’s financial results in the future. Mr. Snyder will demonstrate an easy-to-use system for completing a detailed and accurate research program pro forma.

3:30-4:00 Improving Physician Involvement
Jim Simmer, BSN, MBA, President, Research Answers

Mr. Simmer will discuss the challenges faced with improvement of physician involvement in Research. He will offer strategies on how to efficiently increase physician oversight without being burdensome.

4:00-4:30 Question & Answer Session/ Discussion