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Financial Forecasting

Financial Forecasting. Essential for Clinical Financial Management. General Manager and Vice President Global Product Medidata Solutions. Perry Steinberg. 45%. Of Trial Budgets. Is for Investigator Grants. Solving for Disparate Systems and Cumbersome Integrations. Site Dissatisfaction.

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Financial Forecasting

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  1. Financial Forecasting • Essential for Clinical Financial Management

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

  3. 45% Of Trial Budgets Is for Investigator Grants

  4. Solving for Disparate Systems and Cumbersome Integrations Site Dissatisfaction • Reporting & Forecasting Transparency • Process & Resource Inefficiencies • 71% suffer cash flow issues • 51% prioritize trials that reimburse monthly payments • 30% will stop screening trials that pay on a randomization ratio • 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

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

  6. 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 Poor Forecasting Consequences

  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. 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 Reforecasting Difficulties with Manual Systems

  10. 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. Technology Purpose-Built to Forecast and Plan

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

  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 EDC Calculate Site Trigger Disburse • 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 Site Satisfaction • Reporting & Forecasting Transparency • Process & Resource Efficiencies • 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 • 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

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

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