Sponsors and CROs claim that protocol visits are paid automatically, but when we run an analysis, we find that visits are often missed by the CRO payment process, checks may be authorized but not paid, retainage is not calculated properly, etc. We are an advocate for our clients, who face a complicated process. Knowing which visits have been paid and what to include as Accounts Receivable requires attention to detail, starting with the proper system set up, then managing the system to know which visits have been completed by reconciling payments to ensure that each visit has been paid. Increasingly, CROs and sponsors require invoices to be submitted in their own system. This is a time-consuming task for site staff that should be focused on research and recruiting.

Clinical Trial Agreements include extra procedures that are reimbursed subject to invoice. That invoice must include very specific data and, in some cases, supporting documentation. Most sites do not track all extra procedures and thus leave this money uncollected. Sponsors and CROs are aware of this and pay visits automatically but not extras. Our proposal to the site is to help them to collect these funds, thus it is “found” money for them. Our experience has shown that these extras can become a significant percentage of revenue. Depending upon the therapeutic area, we have seen invoiceable items run from 10% to 50%. 

We help sites to negotiate study budgets to ensure that overhead is adequately charged, per patient budget amounts cover costs, and all potential extras are included in the agreement. We work with the site to develop an Overhead and Charges Policy to explain the overhead rate and fees. Each site has specific requirements. Our participation in budget negotiations and our ability to collect extras increases site budgets by significantly more than the cost of our fees. We believe that the work that sites do is important and should be compensated fully. It is important to keep independent research sites strong and financially healthy.

The first challenge with a CTMS is getting the data entered correctly. Setup is crucial, especially with the move to eSource; a site’s system must be set up carefully for efficient and thorough data entry. We work to ensure that the budget is entered correctly so that all billable items are available for invoice and will be captured in monthly reporting. 

We generate monthly financial reports that track accrued revenue, payments, and accounts receivable, broken down by visits, invoiceables, retainage, and screen failures. This provides a valuable management tool that is difficult to extract directly from the system. This can be used to support bank financing or valuation in the sale of the company. 

Sites need to know how much work has been done in visits and extras, how much has been paid and how much is pending payment (A/R). An aging of Accounts Receivable shows what has not been paid and thus who needs to be called to collect. We follow up on unpaid invoices monthly. This is a major weakness in most site operations. Without active A/R management, sites fail to collect a considerable portion of reimbursement for work completed. 

If you are seeking to sell your site, the valuation will be higher, and financial due diligence will be much easier with a fully functional CTMS, all revenue recognized, and reports to back it up. The financial reports form an essential part of the valuation process. We can help with Business Plan preparation and financial valuation.