Cloudbyz CTFM and EDC: Real-Time Accruals and Forecasts From the Visits You Already Record

Under US GAAP, clinical trial costs are research and development expenses under ASC 730, which must be recognised as they are incurred, when the work is performed, not when an invoice arrives or cash is paid (G-Squared CFO). For site costs, the work is the visits and procedures participants complete. And those are recorded first in one place: the EDC.

Most accrual processes do not use that data directly. Finance asks clinical teams for estimates, or spreads the budget evenly across the months. An article on clinical trial accruals published by SiteCouncil notes that straight-line methods can create a disconnect between what has actually happened in the trial and what is accrued, and that tracking work units against costs gives a much better view of incurred expense (SiteCouncil). The best record of those work units is the EDC.

Accrual methods compared

What EDC data tells finance

• Visits completed, by participant, site and visit number
• Procedures performed, including conditional procedures that are only done for some participants
• Screen failures, which are often paid within agreed limits
• Unscheduled visits and early terminations, which change the cost per participant
• Enrolment pace, which drives the forecast of everything still to come

1. Real-time accruals

When completed visits and procedures in EDC are valued at each site's contracted rates, the amount earned but not yet invoiced is known at any time, by study, site and payee. Month-end becomes a review of an existing number, not the creation of an estimate.

2. Forecasts that follow actual pace

The same data shows how fast each site is enrolling and completing visits. Projecting the remaining visits at that pace, and valuing them at contracted rates, gives a forecast built on the study as it is, not the original plan.

3. Conditional costs that are actually seen

Some procedures are only done when the protocol requires them for a participant. EDC records whether they happened, so they are accrued when performed and forecast from how often they actually occur.

4. Accruals auditors can follow

Each accrued amount traces back to a visit or procedure recorded in EDC, with its date and audit trail. That gives auditors a clear, repeatable basis for the estimate, which matters because clinical trial accruals are often a focus area in audits.

Checklist

• Site budgets built at visit and procedure level
• Completed visits and procedures from EDC valued at contracted rates
• Conditional procedures, screen failures and unscheduled visits included
• Earned-not-invoiced amounts available at any time, by site and payee
• Forecast based on actual enrolment and visit pace
• Each accrued amount traceable to its EDC record

What this means by role

• Finance leadership and controllers: accruals based on recorded activity, ready for month-end and audit.
• Study finance leads: no more chasing study managers for monthly estimates.
• Clinical operations directors: forecasts move as soon as enrolment pace changes.
• Clinical data managers: the data you already manage becomes the basis for finance.

How Cloudbyz CTFM and EDC work together

Cloudbyz CTFM and Cloudbyz EDC are built natively on Salesforce as one platform, together with Cloudbyz CTMS. Visits and procedures completed in EDC are valued against each site's budget in CTFM, so accruals are available in real time rather than estimated at month-end. The CTFM forecasting module uses the same actual progress to forecast spend and enrolment, and can show whether a change order is needed. Payment, accrual and outstanding reports sit in one portfolio-level dashboard, and every number traces back to the visit that created it.

See real-time accruals

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