Run-D.M.C. gave us a memorable refrain: “It’s Tricky.” Accruing for investigator spend earn that description. A monthly accrual can look complete while leaving out site activity that has already occurred. EDC entry, invoices, and payment processing run on different clocks, so finance needs to estimate the work performed by period end and reconcile it as new data arrives.
It’s tricky when a routine extract misses work already completed. Consider a sponsor with 50 active studies and 5,000 payable patient visits completed in October. Suppose 10% of those visits—500 across the portfolio—are entered into EDC after the November 1 payment extract. The visits occurred in October, but they will not reach the payment workflow until the next extract on December 1. If finance prepares its October accrual on November 10 using only pending payment activity, those 500 visits are missing from its view.
If we take an average contracted amount of $3,000 per visit, that is $1.5 million of October activity to assess for the accrual. The 10% lag is an example, not an industry benchmark. The amount ultimately recorded depends on the work performed and applicable contract terms, but the portfolio view shows how an ordinary data delay can become a substantial close-period exposure.
And visits are only part of the picture. Annual fees, supplies, and other invoiceable costs can arrive well after they are incurred; quarterly payment schedules can extend the lag further. A payment ledger shows what has entered or moved through the payment process. It does not show every obligation created by work that has already occurred.
Protocol amendments make budget changes a recurring operational concern. In a 2024 Tufts CSDD study of 950 protocols, 76% had at least one substantial amendment and the mean was 3.3 amendments per protocol. This is a protocol benchmark, not a count of site budget amendments: the budget work required can vary across sites and amendments. Tufts CSDD study
Consider an executed site budget amendment that raises a visit payment from $1,000 to $1,200 effective October 1. If the revised terms are not entered into the financial and payment systems before the October close, 100 eligible visits will be valued at the old rate. That leaves a $20,000 difference to assess for the October accrual. New procedures or invoiceable fees introduced by an amendment will be missed altogether. The effective contract terms must be available for the period in which the work occurs, even if system entry and payment processing follow later.
When incurred site costs are omitted, clinical trial expenses and accrued liabilities may be understated in the period they belong to. Finance and auditors then need evidence that the population is complete, the amount is supportable, and later invoices and payments are reconciled back to the right period. A significant error can lead to prior-period corrections and questions about the controls used to prepare the accrual.
A public example: In 2024, Reviva Pharmaceuticals disclosed that its 2022 research and development expenses and accrued liabilities had been understated by approximately $3.9 million. Its review focused on clinical trial expenses, specifically investigator fees through a CRO, that had been incurred before invoices arrived. Reviva restated affected financial statements and identified material weaknesses in its controls. The company said its process needed to account for site visits not yet reported, average visit costs, and invoicing delays. Read Reviva’s SEC filing.
Start with current site and vendor contract terms, including amendments, so each activity is valued against the applicable budget. Bring in cumulative EDC activity and compare periods to identify visits entered after an earlier extract. Add a reasoned estimate for activity not yet reported where the data lag is measurable. Then reconcile that view to invoices, payment status, and subsequent settlements so the estimate can be refined rather than simply rolled forward.
This is where payment reconciliation becomes part of accrual quality. A visit that occurred, a payment that was calculated, and a payment that cleared are different events. Matching them helps distinguish unbilled activity from unpaid obligations, processing delays, duplicate records, and legitimate adjustments. The result is an accrual finance can explain line by line and test against what eventually happened.
Perfect real-time visibility is unlikely when sites, EDC, vendors, and payment systems update on different schedules. But those delays can be measured and managed. Auxilius brings contract-based forecasts, clinical activity, and payment reconciliation into a connected view, helping teams identify gaps earlier and support the estimates they report.
Trial finance may always be tricky. Explaining the accrual should not be. With activity, effective contract terms, and payment status connected, finance can show how it arrived at the number—and where uncertainty remains.
.svg)
.jpg)