Navigating the Clinical Contract Budget Negotiation Process

1. Navigating the Clinical Contract & Budget Negotiation Process

2. Speakers William Segarra, JD, MPH Sr. Contract Officer Cedars-Sinai Medical Center william.segarra@cshs.org Ryan Schroeder Senior Consultant BearingPoint, Inc. ryan.schroeder@bearingpoint.com \

3. Session Goals Identify Common Issues Identify Key Players Analysis of Internal Business Processes Contract Negotiation Strategies Budget Negotiation Strategies

5. Common Sponsor Issues Sponsor Issues: FDA Regulations Quality Data Site to Data Ratio Enrollment Timelines Budget Constraints/Cost Efficiency Standardize Pricing Across Studies Protection of Intellectual Property Determining Fair Market Value (varies by location) Anti Kick Back Law

6. Common Institution Issues Must Define Institutional Goals: Public Benefit/Mission Protecting Academic Freedoms Policy Development Contracts Negotiated within Policy Guidelines Research Subject Protection Academic Leadership Limit Liability Efficiency Resources

7. Key Players Institution/Site Negotiators Sponsor Contract Administrators/General Counsel Contract Research Organizations (CROs) Principal Investigator & Departmental Staff Institutional Review Board (IRB) Technology Transfer Research Compliance Patient Financial Services

8. Analysis of Internal Process Value Stream Analysis: Value Stream Analysis (VSA) involves the identification and review of the most critical business processes within an organization. VSA(s) include the mapping of those value streams on the processes that are having the greatest impact, developing best practices, creating performance goals and measuring performance. Mapping the process for all parties Develop best practices Develop performance goals Measure performance

9. Contract Negotiation Strategies Reflect Institutional goals and policies Reflect Departmental goals and policies Protect the Financial viability and integrity of all research projects Include budgets that are properly funded and structured in accordance with spending schedules and Institutional costs Conform to Strict Cost Reimbursement Principles Include a thorough Protocol Analysis Prioritize Terms and Conditions in accordance with Institutional priorities/goals

10. Budget/Reimbursement Negotiation Strategies Know the value of your Institution to the Sponsor Primary goal is cost reimbursement and financial integrity of research project Performing Protocol Analysis Negotiate �Front-Loaded� payment structure as much as possible

11. Budget Negotiation Strategies Protocol Analysis: Determine all costs associated with each Protocol Determine the financial impact of the reimbursement schedule Utilize internal resources for patient care pricing Reconcile Sponsor�s designated Standard of Care procedures with Principal Investigator�s determination of Standard of Care procedures Confirm Sponsor�s expectation regarding Third Party Reimbursement for research procedures comports with Institutional policy

12. Financial Analysis of a Clinical Protocol Process: Actively read the Protocol Synopsis Focus on the Schedule of Events Generate an Excel Spreadsheet based upon the information derived from the Schedule of Events Determine �fixed costs�, i.e., IRB Fees, Pharmacy Fees, Advertising, Administrative Start Up Fees, SAE Letter Fees, etc. (if applicable) Insert the applicable dollar amount associated with each procedure Determine Equipment or Supply Costs

13. Performance Measurement Develop Metrics of �Success� Patient Enrollment Goals Academic Publications Financial Viability of the Study Developing Long Term Partnerships with Sponsors (repeat research collaborations) Administrative Efficiency for Project Start-Up

14. Questions?