Managing Clinical Trial Receivables for Department Of Pediatrics

1. Managing Clinical Trial Receivables for Department Of Pediatrics Presented by Guerline St Louis

2. Agenda • Benefits of Managing Receivables • Common Misconceptions • Organizing for Success • Reconciliation report • Collection report • Wrap-up

3. Benefits of Managing Receivables • Improve cash flow • Collect all that is owed to your institution • Generate insights for making informed business decisions

4. Typical Study Cash Flow • Per Subject: $4,400 • Payments: One Subject in Advance / Quarterly Payments / 10% hold back • Profit: 10% • Expenses Jan Feb Mar Apr • Patient # 1 $ 1,200 $ 1,200 $ 800 $ 800 • Patient # 2 $ 1,200 $ 1,200 $ 800 $ 800 • Patient # 3 $ 1,200 $ 1,200 $ 800 $ 800 • Patient # 4 $ 1,200 $ 1,200 $ 800 $ 800 • Patient # 5 $ 1,200 $ 1,200 $ 800 $ 800

5. Monthly $ 1,200 $ 2,400 $ 3,200 $ 4,000 $ 4,000 $ 2,800 $ 1,600 $ 800 Cumulative $1,200 $3,600 $ 6,800 $10,800 $14,800 $17,600 $19,200 $20,000 $20,000 $20,000 Payments Monthly $4,400 $3,564 $7,128 $6,908 $ 2,000

6. Common Misconceptions CRO/Sponsor pay on time and accurately pay for work performed • Roughly 72% are paid “on-time” per the contract payment terms • Roughly 70% of patient payments are paid correctly • Confusing contract terms/language • Poorly trained payables staff • Lack of accountability (CRO and sponsor staff) • If submitted, invoices are paid timely and accurately • Roughly 33% of invoices need to be resubmitted • Lost/never received • Inadequate supporting data • Timing

7. Other Limitations • Clarity on who in the organization is responsible for managing receivables • CTMS flexibility • Not designed as an accounting system • Complexity of study payment terms • Lack of consistent data entry • Lack of training for those managing the process • Accountants – limited clinical training • Coordinators – limited accounting skills • Reluctance of staff to make collection calls

8. Organizing for Success • Establish a “research only” lock box for the receipt of study receivables • Minimizes co-mingling of funds with other business operations • Provides an efficient vehicle for the dissemination of payment detail • Institute a disciplined process for reconciling receivables • Excel spreadsheets • Outsource to a receivables management vendor • Periodically audit receivables management performance

10. When Reconciling Payments… • Request payment detail from sponsor/CRO if not provided with payment • Apply payment to individual visits/pass-through invoices on patient log • Review unpaid visits/pass-through – promptly review discrepancies with sponsor/CRO • Don’t wait too long after the close-out visit to complete your financial reconciliation

11. Collection Tracking • Create an excel spreadsheet listing all of your studies • Include protocol #, PI, sponsor, payee contact, payment terms, past payment received, next payment expected notes • Review on a weekly basis and make collection calls/emails as needed • Email communication is great since everything is documented in writing • Refer back to your patient log when necessary

12. Collection Tracking – Continued • Inform management immediately of any issues resulting in delayed payments • I.e., data not in EDC, queries, CRFs not monitored • Report any discrepancies back to sponsor • Know exact amount owed when requesting payment • Patient number(s) and visit date(s) • Amount due now vs. hold that is due later • Any pass-through costs over due

13. In Summary… Do DON’T • Assume your CTMS will accurately track your receivables • Entrust the receivables management process to a study coordinator • Assume that the sponsor/CRO will pay you correctly • Presume that if you send invoices you will be paid • Wait too long after your closeout visit to complete the final reconciliation • • Push for monthly payment • terms during contract • negotiations • • Understand the payment terms • for your studies; clarify in • writing as needed • • Maintain a reconciliation log to • tie out all payments • • Strategically schedule monitor • visits • • Seek holdback releases for • multi-year studies • • Invoice for archiving and other • items at close of study

14. Thank you! • Feel free to contact us directly if you have any further questions: • Clinical Trials Specialist • • Guerline St Louis • gstloui@emory.edu • Talaya Stevenson • tstev23@emory.edu

15. Children’s Healthcare of Atlanta Presenters: Stacey D. Derico Serrena Slaton

16. Post-Award Administration

17. What is Post-Award? • Post-award activities are those processes and activities that take place after the grant, contract, or cooperative agreement has been awarded to Children's Healthcare of Atlanta.

18. Post-Award • Financial Compliance Monitoring: making sure expenses charged to the project are correct and meet standards and policies set forth by Children’s Healthcare of Atlanta and the Sponsor. • Financial Management: providing financial analysis of expenses and projections to Principal Investigator (PI). Ensure expenses are allowable, reasonable, and appropriate. • Project Reporting: submitting financial progress reports as defined and required by the Sponsor. • Project Close Out: ensuring grants are ready to be invoiced, reported, and closed 30 days after grant cycle end date.

19. Post-Award Quick Tips for Coordinators • Consistent communication with the Grants Administration Team • Review Children’s Notice Of Award (NOA) • Verify salary effort for the grant with PI • Only order supplies, equipment, etc. that are budgeted and approved by the Sponsor and PI

20. Post-Award Tips Tips to Keep You Going • Complete the Patient Tracker within 24 hours of any patient receiving services at Children’s • Ensure you have access for managing your studies in CTMS • Enter enrollment visits in the Clinical Trial Management System (CTMS) within 24 hours • Keep track of the status of subcontracts for Children’s services; no patients can be seen at Children’s facilities without a fully executed subcontract • Provide any updates to the protocol or study implementation (amendments etc.) to Children’s as soon as possible • Review, sign and return ancillary invoices in a timely manner • Provide an IRB number if available or confirm it is pending approval

21. Available Resources • ActFast • Award Summary • Budget, expenses, and remaining balance • PR Ledger • FTE Trend (provides FTE by pay period) • Export (provides dollar amount per pay period) • AC Detail (provides transaction detail) • AP Subledger

22. Contact Information • Stacey D. Derico – stacey.derico@choa.org • Serrena Slaton – serrena.slaton@choa.org • Grants Administration – grantsadmin@choa.org

23. Questions?