Clinical trial accruals at quarter end, built line by line from contracts, recorded work and invoices — with the evidence for every line
Every study's quarter-end accrual built from contracts, activity and invoices, with the evidence for every line.
See one case, screen by screen ↓R&D cost is recognised as the work is performed, whatever the invoice timing. So at every quarter end someone in clinical accounting has to work out, study by study and vendor by vendor, what was earned to date — visits completed, monitoring visits done, kits processed, reads finished, percent complete on fixed fees — and set it against what has been billed.
The inputs live in different places: unit rates and caps in work orders and change orders, visit counts in EDC, monitoring visits in CTMS, kits and reads in vendor transfers, invoices in the ERP, the rest in accrual questionnaires from study managers. Pulling them together takes most of the day, and the checks that matter — is this invoice billing visits that never happened, a rate before its effective date, screen failures above the cap — are the ones that get squeezed when the journal entries are due.
Estimated split for one study, by hand and with the solution, in hours.
Four agents build each study's schedule from contracts and recorded work and two more write the entry and the forecast; the preparer decides every flag.
Working day 5 of the Q3 close. Journal entries post by Thursday at noon, and VLT-302 — a Phase 3 ulcerative colitis study with 142 sites and three vendors — still has open flags. Here is how it gets to posted, screen by screen, in the working solution.
Dana opens the close cockpit: $3.56M of Q3 accrual to book across 7 of 8 studies built, $9.79M prepaid at Sep 30, 8 open flags with $280k billed above the recorded work, and 2 of 8 studies posted. The close clock counts down to Thu Oct 8, 12:00, and the checklist shows questionnaires returned, vendor confirmations in and the EDC and CTMS cut-off loaded.
“Tessaly Research sent the NXL-220 accrual confirmation · 07:55 — ready to build”
One click on Build NXL-220. The contract reader turns four contracts into a rate card, the activity matcher takes the EDC, CTMS and imaging counts at the Sep 30 cut-off, the accrual calculator builds every line and the billing checker runs its six checks. Result: $203,800 to accrue and one flag — invoice TR-88541 bills 88 standard tumour imaging reads at the $640 expedited rate instead of $410.
“NXL-220 built — $203,800 to accrue · 1 flag to decide”
Contract $148.60M, earned to date $65.32M, billed to date $66.96M: an accrual of $1,675,048 and a prepaid of $3,321,570. Four agents built the schedule with 41 citations. Dana clicks site monitoring visits: 2,980 visits before Jun 1 at $2,640 plus 432 from Jun 1 at the Change Order 2 rate of $2,850 — and each term opens its source: the CTMS log, Change Order 2 or the Kestrel invoice.
“Change Order 2 raised the rate only for visits on or after Jun 1, so each visit is priced at the rate in force on its visit date.”
Patient visits — Visit 6 (Week 12): 486 completed in EDC to date (336 to Jun 30, 150 in Q3) at $1,180 from Exhibit B of the site budget gives $573,480 earned. Kestrel has billed 636 visits — $750,480. The $177,000 difference sits in prepaid, not in the accrual.
Line 14 of Kestrel invoice KC-2026-0917 bills 300 Week-12 visits where EDC shows 150: $177,000. Screen failures are billed above the one-per-three-randomised cap: 251 against 204, $30,080. The new monitoring rate was applied to 69 May visits: $14,490. On the other side, Larkfield has not invoiced 2,296 kits since July ($730,128), and Change Order 3 started Sep 15 with nothing billed ($184,800).
“Each flag cites the invoice line, the contract clause and the recorded activity. The suggested action is a proposal — you decide.”
Dana can dispute each billing flag or accept it with a note, and accrue or exclude each unbilled one. She applies the suggested actions: three disputes drafted for Kestrel, the Larkfield kits and Change Order 3 accrued. Each decision carries her name and time, with Undo beside it. The study moves on to clinical operations.
“Every flag decided — Priya Raman asked to confirm the activity counts”
Once Priya Raman confirms enrolment, visit counts and amendment dates, the entry drafts: debits to R&D clinical expense for CRO service fees $382,200, investigator grants $178,300, central lab and imaging $795,448, change orders $184,800 and pass-through costs $134,300; a credit of $1,675,048 to 2215-00 accrued clinical trial costs. Period 09-2026, auto-reversing Oct 1.
Purpose and period, method, result, judgements and decisions, bridge and look-back, conclusion. Each flag is listed with its decision and amount. The look-back is stated plainly: invoices received in Q3 for Q2 work came to 97.2% of the $1,420,000 Q2 estimate — a 2.8% difference, inside the 5% tolerance.
Dana signs as preparer with the meaning “Prepared and reviewed — every line supported”. Omar is notified and approves with his password and the meaning “Approved for posting — review control performed”.
“The signature is recorded with name, time and meaning in the audit trail.”
Approval posts JE 2026-09-4480 to the ERP for period 09-2026 with a reversal on Oct 1. The three dispute letters go to Kestrel with the evidence, and the schedule, sources, decisions, memo and both signatures are filed to the audit pack.
The same close, seen by the five people who carry it — what their quarter end looked like, and what it looks like now.
Four agents build each study's schedule from contracts and recorded work and 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 — and maps every count to a contract line.
Computes earned to date per line with the method set for its cost family, compares it with billed to date from the ERP and gives the accrual or prepaid — with the full build.
Compares every invoice line with the contract and the recorded work: billed above activity, rates before their effective date, caps, duplicates, missing invoices and change-order work not yet billed.
Drafts the accrual journal entry by cost family and the accrual memo — method, judgements, decisions on flags and the bridge from last quarter — for the preparer and controller to sign.
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.
Decides every flag. The agents propose; a named person decides.
The assistant answers from the contracts and change orders, the EDC and CTMS activity, the vendor invoices and the ERP ledger for the studies in the close — and shows the passage behind every number. It can also take a new check in plain words.
Why did the VLT-302 accrual move this quarter?
The Q2 accrual of $1,420,000 reversed on Jul 1; Kestrel and the other vendors billed that work in Q3 within 2.8%. The Q3 accrual is $1,675,048 — up $255k. The two drivers are Larkfield, which has not invoiced since July, and Change Order 3, signed Sep 12 and started Sep 15. Separately, 3 invoice lines bill $222k above the work — they sit in prepaid until you decide.
Which invoices bill more than the work done?
5 invoice lines bill more than the recorded work — $279,795 in total. The largest is VLT-302: Kestrel billed 300 Week-12 visits where EDC shows 150.
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.
Why is the advance still prepaid?
Because it has not been earned yet. Work Order 01 says the $3,100,000 mobilisation fee is non-refundable and is applied against the final 10% of service-fee invoices. A non-refundable advance for future R&D work is deferred and expensed as the work is performed — so it stays in prepaid clinical costs until Kestrel reaches those final invoices.
13 screens from the working solution, on its sample data. Pick one to see it large.
How each cost family is estimated, what goes to the controller, what the checks look for and who signs — all settings.
| Setting | Default | Choose from |
|---|---|---|
| CRO service fees | 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 |
| Controller review threshold | $250,000 move since Q2 | Raise or lower |
| Look-back tolerance | 5% | Raise or lower |
| Auto-reverse accrual entries | On — first day of the next period | On · Off |
| Controller approval | Omar Haddad | Omar Haddad · Lena Ortiz |
| Checks the agents run | Six checks | Describe a check in plain words |
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 studies · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published clinical accrual case studies (a full day per study by hand; 3–5 trials take nearly a week each quarter end). People, companies and products named on this page are fictional — characters and sample data in the working solution.
Software that works out, at each period end, what a sponsor owes for clinical trial work that has been done but not yet billed — and what has been billed ahead of the work. The Clinical Trial Accrual Workbench builds each study's schedule from CRO contracts, change orders, site budgets, EDC and CTMS activity and invoices, then drafts the journal entry and memo.
Line by line, with the method set for each cost family: units recorded at the cut-off times the contract rate in force on the activity date, contract value times percent complete for fixed fees, cost incurred for pass-throughs. Billed to date comes from posted and parked invoices in the ERP. The accrual is earned minus billed; non-refundable advances stay prepaid until applied.
It runs six checks on every invoice line: units against recorded activity, rates in force on the activity date, caps and ceilings, duplicate invoices, activity with no invoice for 45 days, and change-order work not yet billed. Each flag shows the evidence and the amount at stake; a person decides, and disputes go to the vendor with the evidence.
A change order supersedes the earlier rate only from its effective date, so each visit is priced at the rate in force on the day it happened. Signed change orders with work started are accrued on the share done, as confirmed by clinical operations; work begun before a change order is signed is accrued as an estimate and noted as unsigned.
Yes. The agents compute and flag; the preparer decides every flag, clinical operations confirms the activity counts, and the entry posts only after the preparer and the controller have both e-signed. Every step is on the study's activity trail.
A roll-forward of accrued clinical trial costs, support for any sampled line back to its contract clause, activity row and invoice, and the look-back of last quarter's accrual against the invoices that followed. The schedule, sources, decisions, memo and signatures are filed to the audit pack at posting.
Your ERP for accounts payable and the general ledger, CTMS, EDC, the vendor portal for accrual confirmations, your contract system, and lab and imaging data transfers. It reads them at the period cut-off and posts the approved entry back to the ERP.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your accrual policy, contracts and a sample of past schedules — and it goes live once every quality gate has passed. We will run it on a past quarter of your own studies first.
Every quarter's rebate reserves rebuilt from source, with a citation on every number the auditor asks about.
1-min filmMedicaid RebatesEvery state invoice checked line by line, every dispute backed by the claim rows behind it.
1-min filmAlliance StatementsEvery partner’s quarterly profit-share statement built from the ledger and the agreement, each number traced to its clause.
1-min filmWe’ll build last quarter’s accrual for a few of your own studies and compare it with what you booked.