Clinical trial accrual software that ties every accrual line to its contract, change order and invoice
Every accrual line tied to its contract, change order and invoice.
See one case, screen by screen ↓Software that builds a sponsor's quarter-end accrual for clinical trial costs — the work done by CROs, sites, labs and imaging vendors but not yet billed. Clinical Trial Accruals uses agents to read the contracts and change orders, match EDC and CTMS activity at the cut-off and compute earned minus billed per line, with every number cited, for the clinical accountant to decide and sign.
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Clinical trials are a sponsor's largest R&D cost, and almost all of it is billed after the work is done. CROs invoice monthly in arrears, central labs and imaging vendors invoice when they choose, and change orders bill only after signature. So at every quarter end the clinical accountant books the work done but not yet billed — one spreadsheet per study, built from the work orders and change orders, the CRO's accrual confirmation, EDC and CTMS exports and the ERP ledger, about a full day per study.
The CRO's own estimate is cut before quarter end. It misses late screening, change-order work not yet billed and work above contract ceilings, so the sponsor's number and the vendor's rarely agree and the gap is explained in email. Visits billed with no visit in EDC, screen failures above the cap, new rates applied before their effective date and duplicate invoices are found late or paid. And last quarter's accuracy is known only when the invoices arrive — the estimate auditors test every year.
Estimated split of about a full working day per study by hand, and the 3.6-hour target with the solution.
Four agents build each study's accrual and set it against the vendor's own estimate, two more write the entry and the forecast; the preparer decides every flag.
Q3 2026, working day 5. Eight studies, six vendors, entries post Thu Oct 8 at 12:00. Tessaly Research's accrual confirmation for NXL-301 — Talmirex with standard chemotherapy in non-small cell lung cancer, Phase 3, 46 sites — lands at 07:55. Here is what happens next, screen by screen, in the working solution.
Studies run down the side, cost categories across: CRO fees, site costs, lab and imaging, change orders and pass-throughs. Each cell is the work done to Sep 30 and not yet billed, coloured by how far it is from the vendor's own estimate — within 10%, 10–25%, over 25%, or not in the estimate. Seven studies were built overnight: $3.56M against the vendors' $2.82M, with VLT-302's lab and imaging 83% above Kestrel's estimate.
“Larkfield’s confirmation was sent on Sep 9 and counts the 1,184 August kits only.”
Dana loads Tessaly's confirmation on the map. The contract reader turns the contracts into a rate card, the activity matcher takes the EDC, CTMS and imaging exports at the Sep 30 cut-off, the accrual calculator works out earned against billed for 5 lines, and the billing checker runs its six checks. The NXL-301 row fills in cell by cell.
Every step shows what it read and what it found, with its timing.
Our site-costs accrual is $112,200; Tessaly's estimate is $81,300, a difference of $30,900, or 38%. Tessaly dated its confirmation Sep 26 and assumed 31 screening visits in September. The EDC cut-off shows 43 — 12 extra patients screened in the last four days of the quarter — and at the $2,575 screening grant in the site budgets that is the whole $30,900.
Sources: “EDC screening log · cut-off Sep 30”, “Site budgets · screening visit”, “Tessaly confirmation · Sep 26”.
Each cell carries its bridge: the Q2 accrual, the invoices against it, the amount billed for Q2 work, the new Q3 work and the Q3 accrual. The Q2 look-back reading recolours the whole map by how close last quarter's accrual came to the invoices that followed — 93.3% on this cell.
Dana keeps the $112,200 — the reason goes into the accrual memo — and sends Tessaly the variance with its sources; the reply lands in the cell. She opens the schedule: NXL-301 accrues $203,800, with $20,240 in prepaid. Click any amount and the passage behind it opens: 4,410 patient visits at each site's budget rate, earned $5,402,300, billed $5,290,100.
“Each completed visit in EDC priced with its own site’s budget.”
Line 14 of Kestrel invoice KC-2026-0917 bills 300 Visit 6 (Week 12) visits; EDC shows 150, so $177,000 is billed with no recorded visit. Screen failures are billed above the one-in-three cap ($30,080), Change Order 2's new monitoring rate is applied to 69 May visits ($14,490), Larkfield has not invoiced August and September ($730,128), and Change Order 3 started Sep 15 and is not billed ($184,800).
“The suggested action is a proposal — you decide.”
Nine open flags across four studies: $300k billed above the work, to dispute before accounts payable pays, and $1.01M of work with no invoice, to accrue. Invoice ALD-55120 on NXL-105 was billed twice; 88 standard tumour reads on NXL-301 were billed at the expedited rate. Dispute letters go to the vendors with the evidence.
For CVT-201, Corventa in pulmonary arterial hypertension, the entry debits R&D clinical expense by cost family and credits accrued clinical costs: $755,660, balanced, auto-reversing Oct 1. The memo states the method, the result, each judgement — the duplicated echo reads disputed, patient travel above the $620,000 ceiling accepted with a note — the bridge and the look-back: Q2 invoices came to 96.1% of the estimate.
Sam Patel signed as preparer on Oct 6. Omar Haddad records the controller approval — “Approved for posting — review control performed” — with his password.
“The signature is recorded with name, time and meaning in the audit trail.”
Approval posts JE 2026-09-4484 to period 09-2026 with an auto-reversal on Oct 1, sends the dispute letters to the vendors and files the schedule, sources, decisions, memo and signatures to the audit pack.
The same close, seen by the five people who carry it — in their own words, and what their quarter end looks like now.
Four agents build each study's accrual and set it against the vendor's own estimate, two more write the entry and the forecast; the preparer decides every flag.
Reads work orders, change orders, site budgets and lab agreements and turns them into a rate card per study: unit rates, fixed fees, caps, advances and effective dates — each with its clause.
Pulls the cut-off activity — EDC visits, CTMS monitoring visits and site-months, lab kits, imaging reads, CRO status reports — and maps every count to a contract line, keeping the export row behind it.
Computes earned to date per line with the method set for its cost family, compares it with billed to date from the ERP ledger, sets each study and cost category against the vendor's estimate and explains every gap over 10%.
Compares every invoice line with the contract and the recorded work — billed above activity, rates before their effective date, caps and ceilings, duplicates, activity with no invoice for 45 days and change-order work not yet billed — with the amount at stake and a suggested action.
Drafts the accrual journal entry by cost family, reclassifies billed-ahead amounts to prepaid and marks the entry auto-reversing; writes the memo with the method, judgements, decisions on flags, the bridge from last quarter and the look-back.
Projects the next two quarters of earned spend from the enrolment and visit plans with the same rate cards, so the forecast and the accrual agree, and shows it by month and cost family against the budget.
Decides every flag. The agents propose; a named person decides.
Ask in plain words, or say what to change. Every answer points to the contract clause, export row or invoice line behind it.
Why are NXL-301 site costs above Tessaly's forecast?
NXL-301 site costs come to $112,200 at Sep 30; Tessaly's accrual confirmation says $81,300 — 38% above, a $30,900 difference. Tessaly dated its estimate Sep 26 and assumed 31 screening visits in September. The EDC cut-off shows 43: 12 extra patients screened in the last four days of the quarter. At the $2,575 screening grant in the site budgets that is the whole $30,900.
Why did the VLT-302 accrual move this quarter?
The Q2 accrual reversed on Jul 1, and Kestrel and the other vendors billed that work in Q3 within 2.8%. The two drivers of the increase are Larkfield, which has not invoiced since July, and Change Order 3, signed Sep 12 and started Sep 15. Separately, the invoice lines billed above the work sit in prepaid until you decide.
Flag any invoice that bills a visit before it shows in EDC
Done. New check: an invoiced visit must appear in EDC with a completed visit on or before the invoice period end. Run across the Q3 invoices for all 8 studies, it finds one new flag: NXL-105 — Aldermoor billed 3 September patient-months at site 1104 with no EDC visit, $14,550. The check is live in Settings and recorded in the audit trail.
Draft the Q3 roll-forward for the auditors
The roll-forward of accrued clinical trial costs (account 2215-00) shows each study's opening balance, the Jul 1 reversal and the Q3 accrual. Each closing balance ties to its study schedule, and every line opens its contract clause, activity row and invoice. It is added to the audit pack for Lena Ortiz.
13 screens from the working solution, on its sample data. Pick one to see it large.
How each cost family is estimated, what the controller sees, what the checks look for and who signs — set once, versioned and on the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| CRO service fees | Percent complete and unit-based | Percent complete and unit-based · Percent complete · Unit-based · Activity-based · At cost · Milestone |
| Investigator grants | Activity-based — each completed visit at its own site's budget rate | Activity-based · Percent complete · Unit-based · At cost · Milestone |
| Central lab and imaging | Unit-based — kits and reads from the vendor's transfer | Unit-based · Percent complete · Activity-based · At cost · Milestone |
| Change orders | Percent complete — share done, confirmed by clinical operations | Percent complete · Unit-based · Activity-based · At cost · Milestone |
| Pass-through costs | At cost — per the pass-through report | At cost · Percent complete · Unit-based · Activity-based · Milestone |
| Controller review threshold | $250,000 move since Q2 | Step up or down |
| Look-back tolerance | 5% | Step up or down |
| Auto-reverse accrual entries | On — reversal on the first day of the next period | On · Off |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample close · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = a published figure (clinical trial accrual software vendors such as Condor Software put the manual build at about a full day per study). Accounting context: FASB ASC 730 (research and development); audit context: PCAOB AS 2501. People, companies, studies and products named on this page are fictional — characters and sample data in the working solution.
Software that builds a sponsor's quarter-end accrual for clinical trial costs — the work done by CROs, sites, labs and imaging vendors but not yet billed. Clinical Trial Accruals uses agents to read the contracts and change orders, match EDC and CTMS activity at the cut-off and compute earned minus billed per line, with every number cited, for the clinical accountant to decide and sign.
Every study and cost category is set against the vendor's own estimate on one map: within 10%, 10–25%, over 25%, or not in the estimate. A gap over 10% comes with its reason and its sources — for example, screening visits completed after the CRO cut its estimate — and the preparer decides whether to keep the accrual and ask the vendor to confirm.
The billing checker runs six checks on every invoice line: units billed against recorded activity, rates in force on the activity date, caps and ceilings in the contract, duplicate invoices, activity with no invoice for 45 days, and change-order work not yet billed. Each flag shows the amount at stake and a suggested action, and you can describe a new check in plain words.
Amounts billed ahead of the work are reclassified to prepaid in the journal entry. A non-refundable advance, such as a mobilisation fee applied against the final service-fee invoices, stays prepaid until it is earned.
Yes. Every cell carries a bridge from Q2 — the Q2 accrual, the invoices against it, the amount billed for Q2 work, the new work and the Q3 accrual — and the look-back reading shows last quarter's accrual against the invoices that followed, cell by cell, with a tolerance you set.
Yes. The agents compute, compare and flag; the preparer decides every flag and every cell kept above a vendor's estimate, the study manager confirms the activity counts, and the entry posts only after the preparer's and the R&D controller's e-signatures.
Yes. The method for each cost family, the controller review threshold, the look-back tolerance, auto-reversal, the checks and who prepares and approves are all settings. A change is saved as a new version and recorded in the audit trail.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your accrual policy, contracts and a past quarter's close — and it goes live once every quality gate has passed. We will walk you through it on your own studies first.
Every reserve assumption cited to its contract, lag curve or payer mix
1-min demoMedicaid Rebate Invoice ValidationSuspect units disputed with claim-level evidence, and the dispute letter drafted.
1-min demoAlliance Profit-Share AccountingEach quarterly allocation traced to the ledger and the agreement clause
1-min demoWe'll run Clinical Trial Accruals on a past quarter of your own contracts, CRO estimates and invoices.