What Is Clinical Trial Finance Software? A Plain Guide, With Cloudbyz CTFM as an Example

Smit Shah
CTBM

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Clinical trial finance software, also called clinical trial financial management (CTFM) software, manages the money in a clinical trial: study and site budgets, site agreements, visit-based site payments, invoices, accruals, forecasts and change orders. Cloudbyz CTFM is a Salesforce-native clinical trial finance system used by organisations from emerging biotechs to large pharma, global multinationals, CROs and medical device companies.

What it does

Function

What it covers

Budgets

Study budgets, and site budgets built from the visit schedule and rate cards

Agreements

Site, CRO and vendor agreements, amendments and payment terms

Site payments

Amounts earned from completed visits, holdbacks and payee splits

Invoices

Site invoices for pass-through and non-procedure costs, checked against the budget

Accruals

Work done but not yet invoiced, for month-end

Forecasting

Projected spend and enrolment, and change order impact

Reporting

Paid, unpaid, accrued and outstanding amounts by study and portfolio

Why trials need dedicated finance software

  • Accounting rules. Under US GAAP, clinical trial costs are expensed as incurred (ASC 730), so accruals have to reflect the work actually done (G-Squared CFO).
  • GCP. ICH E6(R3) expects the financial aspects of a trial to be documented in an agreement before it starts (ICH E6(R3), EMA Step 5).
  • FDA requirements. Investigator financial disclosure must be collected, and FDA may refuse to file an application without it (21 CFR 54.4).
  • Scale. A single global study can involve hundreds of sites, payees, currencies and agreements, which spreadsheets and general accounting systems were not built to track.

How it differs from ERP and CTMS

  • ERP or accounting systems record payments and post journals, but don't understand visits, procedures or site budgets.
  • CTMS tracks study operations, such as sites, visits and monitoring, but not budgets or payments.
  • Clinical trial finance software sits between them, turning study activity into earned amounts, payments and forecasts. It works best when it shares data with the CTMS and EDC.

Who uses it

Study finance teams, clinical operations leaders, CTMs, contracts teams, site finance teams and senior management, at sponsors and CROs of every size.

How Cloudbyz CTFM works

Cloudbyz CTFM is built natively on Salesforce, on the same platform as Cloudbyz CTMS, EDC and eTMF, so visits, milestones and enrolment feed budgets and payments without integration between them. It covers budgets from templates and rate cards, agreement tracking, visit-based payments with payee splits, non-procedure costs with limits per unit, site invoice reconciliation, real-time accruals, forecasting with change order modelling, and portfolio dashboards with report subscriptions. It is used by organisations ranging from emerging biotechs to large pharma, global multinationals, CROs and device companies.

See Cloudbyz CTFM

Book a demo or visit cloudbyz.com.

Diverse Team Reviewing Clinical Finance Dashboard In Modern Office