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

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

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

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

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

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

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

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

Patient Tracker Log Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 MRI Budget $3000.00 $5000.00 Visit name Screening Wk 2 Wk 4 Wk 8 Wk 12 ET If app Pt Number Pt Initials (Invoice) 2001 ABC 09/01/19 09/15/19 09/30/19 10/30/19 2002 TUL 09/12/19 09/28/19 2003 MBG 2004 TS 2005 GST 2006 LOL

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

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

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

In Summary… Do DON’T • Assume your CTMS will accurately track your • 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 • 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

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

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

Post-Award Administration

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.

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.

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

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

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

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

Questions?