The new age clinical research sites are becoming increasingly selective about which sponsor/CRO they would want to work with on industry-sponsored clinical trials. One selection criterion that sites stringently look out for is how efficient, timely and transparent is the investigator/site payment process. Sponsors and CROs who manage the financial lifecycle smoothly are highly valued by the sites and gain a competitive edge in becoming the “Sponsor of Choice”.
Know the WHY
Let’s see the many challenges and issues that a clinical site faces during the accrual and reconciliation of site payments.
The Manual Process of Site Pay-out
Since long, site pay-out processes have taken a toll on investigative sites. The administrative burden of accounting and reconciliation using the old manual payment system is not only cumbersome, tedious and time-consuming but is also prone to errors. These also account for a considerable amount of resources at the site due to multiple reasons –
- Sites create the invoice, track payment milestones and reconcile payments using paper or spreadsheets and by checking multiple systems.
- Most of the sites do not have a dedicated resource with accounting expertise to perform these tasks & engage study personnel whose primary role is not related to handling finances; thus, causing distractions from their core research activities.
- Sites raise multiple invoices for – ethics committee payment, study milestone payment, patient stipends, and travel reimbursement and pass-through expenses. The increasing complexity of the study protocol and adaptive clinical trial designs further make the payment calculations and tracking more complex and cumbersome.
- To raise an invoice, site personnel has to manually
- Match site activity with contractual terms
- Check completed milestones to determine if payment is triggered
- Tally the milestone with study monitor to confirm both the site & sponsor are on the same page
- Reconcile patient travel reimbursements and raise the invoice
- Check tax and VAT requirements
- Check if any amount is withheld by the sponsor
- Sites often do not receive remittance advice from the sponsor making it extremely difficult to track payment deliverables against the invoice generated. It is often a challenge for sites to reconcile their activities without the details of payment line items like subject identifier, visit number, and visit date and which items are paid versus not paid.
- Most sites receive payments via check which they have to manually process.
- Many sites do receive payments via EFT but need to spend an inordinate amount of time to coordinate with the accounts department to make them understand the payment terms and rules for the monies received for different studies from different sponsors.
- Some sites receive payments via both check and EFT, which further adds complexity to track the payments received.
- Many sponsors pay in foreign currency placing an additional burden on sites to calculate the dynamic exchange rates.
- Siloed tools and legacy systems make end-of-study reconciliations extremely lengthy and tedious.
Payment Visibility and Control
Clinical trial sites do not have visibility into when the payments will be received after an invoice is generated, making the execution of trial procedures difficult. Without a centralized payment platform, they are burdened with the unnecessary workaround of tracking payment status.
Most of the sponsors have long payment cycles and pay every quarter which keeps sites at a financial deficit. While most of the sites would wish to be paid in standard business time of 30 days for their services, it is ironic to know that many sites would prefer less frequent pay-outs at longer intervals. This is because of the inherent “headache” that comes with the reconciliation of funds, so much so that they would prefer to only have to deal with this process quarterly rather than every month.
Sponsors usually take around 1-2 months for processing the invoices raised by the sites. Thus, it is almost 6 months from the time that the site raises the invoice for services already provided, making it difficult to keep the site engaged and retained.
Know the How
Fortunately, today we have an option of various eClinical solutions that address investigator site payment issues head-on with integrated automated payment systems. While most of the clinical trial management systems (CTMS) provide multiple features beneficial to all stakeholders, from site perspective the most valuable ones are –
- Match subject visit milestones with contractual terms and data sources on applicable e -clinical platforms (EDC, IWRS, CTMS) to trigger site payment
- E-invoices – Eliminate the need for manual invoice generation
- Upload e-invoice on a central portal – Eliminate the need for manual processing
- Itemized e-remittance advice linked to payments processed
- Central Dashboard to
- View and Access Invoices
- Check for milestones paid versus delayed or denied
- Track payments processing timeline
- Review accrued study revenue to date
- 24/7 access to payment status
- Monthly payment schedule
- Local currency pay-out or integrate the exchange rate to the final invoice
- Electronic pay-outs with automated alerts
- Provision to release patient travel costs triggered by visits completed in EDC or IWRS
- Provision to request and receive pass-through expenses
- Accommodate modification in site pay-outs that may occur because of any midstream changes to contractual terms in lieu of protocol amendments.
- Communication channel for issue escalation and resolution in case of any site payment discrepancy
Clinical research site payment issues are for real and can lower the morale of site personnel resulting in poor site engagement and performance. Sites sub-consciously pay less attention to studies with frequent payment issues and occasionally may even decide to stop working with sponsors where payment issues are persistent.
Sponsors, CROs, clinical trial sites and eClinical Solution providers, all must join hands to collaborate and find a practical, transparent and all-inclusive solution that streamlines payment processes for sites; so that they remain completely focused on the important tasks of clinical research.
Contact us to find out how Octalsoft CTMS helps you address this challenge and enables you to process Investigator Payments efficiently in a timely and transparent manner.