Financial Forecasting Essential for Clinical Financial Management

Perry Steinberg General Manager and Vice President Global Product Medidata Solutions

45% Of Trial Budgets Is for Investigator Grants Reference for portion of clinical budget allocated to Site Grant Payments   https://www.clinicalleader.com/doc/clinical-investigator-payment-best-practices-0001 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.

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

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

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

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

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

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

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.

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”

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

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

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

Perry Steinberg General Manager and Vice President Global Product Medidata Solutions