1. Financial Forecasting
Essential for Clinical Financial Management

2. Perry Steinberg General Manager and Vice President Global Product
Medidata Solutions

3. 45% Of Trial Budgets Is for Investigator Grants
Reference for portion of clinical budget allocated to Site Grant Payments
Investigator Payments/Grants: An Introduction
Investigator grants have three components — investigator compensation, overheads, and administrative costs. Among this, the investigator compensation component contributes 40 to 50 percent of the overall trial cost. It includes payments to investigators, physicians, and other staff. Figure 1 defines investigator grants as a category.

4. Solving for Disparate Systems and Cumbersome Integrations
Reporting & Forecasting Transparency
Process & Resource Inefficiencies
Site Dissatisfaction
Reconciliation, accrual and forecasting delays
Invoice tracking to ensure payment
Audit ready transactional reports
Disparate systems requiring multiple integrations
Manual steps impacting data quality, timeliness, compliance and FTEs
OUS regulations, indirect tax and currency exchange variations
71% suffer cash flow issues
51% prioritize trials that reimburse monthly payments
30% will stop screening trials that pay on a randomization ratio

5. Financial Conundrum Poor Forecasting Consequences
Difficulties with Manual Systems
Evaluating Purpose-Built Technology

6. Poor Forecasting Consequences
Cash Flow
FTE Burden
Trial Delays
Budget Inaccuracies
Escrow Funding Adjustments
Late and Inaccurate Site Payments
Reconciliation Efforts
Tracking and Reporting
Audit Readiness
Site Enrollment of Subjects
Drug Supply
Third Party Services

7. Understanding what remains to be paid and
forecasting reimbursements relieves cash flow challenges.
SCRS White Paper:
Site Budget Development and Payment Systems: A Call for Transparency from Clinical Research Sites, Sep 2017

8. Impact to Sites
71% “
…we were spending more money on labor chasing the money we were entitled to...If that happens every year, then I’m going bankrupt.
financial stress ”
51%
Vivienne Van Der Walle
Medical Director, PT&R, The Netherlands
prioritize trials paying monthly

9. Reforecasting Difficulties with Manual Systems
Trial Management
Country Regulations
Data Transparency
Adaptive Trial Designs
Protocol Amendments
Paper Consents
Indirect Tax
Currency Exchange
Banking Approvals
Site Submissions
Excel Errors
EDC Currency
Invoice Processing Delays

10. Technology Purpose-Built to Forecast and Plan
Ingests multiple data sources
Utilizes real time information
Easy to use and audit ready
Realize real-time and accurate financial forecasts by integrating with:
EDC
Grant
RTSM
Enables turnkey reconciliation based on work performed.
Provides true financial reporting for actuals, forecasting and risk mitigation.
Familiar and intuitive user interface by all stakeholders.
End-to-end audit trail for inspection readiness and regulatory compliance.
Privacy, security and regulatory certified.

11. Leveraging EDC Automation for Real Time Visibility
Payments
EDC & Payments integration
EDC without Payments integration
~60 days or more for updates
Automatic hourly cost updates
Data Drop Box
Monthly Export
Data Cleansing / Reconciliation
Incomplete eCRFs difficult to track, manage, “get lost in shuffle”

12. Enabling Financial Management
SETUP
TRIGGER, CALCULATE AND DISBURSE
REPORT
Sites
Trigger Calculation
Calculate Total
Remittance Letter
Contract Costs
Generate Costs
VAT & Withholding Tax
Track Payments
Payees
Request Invoice
Apply Exchange Rates
Track Accruals
Integrations
Set Pay Schedule
Transfer Funds
Transparency Reports
Seamless integration for quick and accurate global payments
Real-time reporting and insights for effective trial management
Reliable forecasting and adjustments for fiscal planning

13. Reporting and Transparency
Site
Disburse
Calculate
Trigger
EDC
Accruals
Costs Awaiting Approval (Total/Study)
Costs Approved
Study Cost Accruals
Event Costs by Payee (Study/Trigger)
Payments
Awaiting Approval
Unprocessed (Payee/Study)
Processed
Information
Funding Request
Accounting
Full Transactional Report
GL Export
VAT Credit Report
Withholding Tax Summary
Foreign Exchange Summary
Transparency
Open payments

14. Enrollment Models Enable True Financial Management and Increase Site Satisfaction
Reporting & Forecasting Transparency
Process & Resource Efficiencies
Site Satisfaction
Reconciliation, accrual and forecasting in real-time for all stakeholders
Tracking and managing complex financial scenarios
Built for purpose reports and notifications
Elimination of repeat data entry reducing errors, delays and FTE allocations
Global regulatory compliance with indirect tax and currency exchange requirements
End-to-end audit trail ensuring inspection readiness
Predictable and reliable cash flow for work completed
FTE elimination for reconciling, reporting and “chasing” payments
Focus on study conduct vs. administrative tasks
EDC maintenance and accuracy improvement

15. Perry Steinberg General Manager and Vice President Global Product
Medidata Solutions