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
Patient # 2 $ 1,200 $ 1,200 $ $ 800
Patient # 3 $ 1,200 $ 1,200 $ $ 800
Patient # 4 $ 1,200 $ 1,200 $ $ 800
Patient # 5 $ 1,200 $ 1,200 $ $ 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

9. Patient Tracker Log
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
MRI
Budget $ $
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

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/ s as
needed
• 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
• 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

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

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 –
Serrena Slaton –
Grants Administration –

23. Questions?