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Large pharma needs clinical trial financial management (CTFM) software that shows the whole portfolio in one place: spend, accruals, outstanding payments and forecasts across every study, region and site, with controls that stand up to auditors and regulators. Cloudbyz CTFM is a Salesforce-native clinical trial financial management system that gives large pharma and global multinationals this portfolio-level view, on the same platform as Cloudbyz CTMS, EDC and eTMF.
Why portfolio finance is different at large pharma
- Financial reporting controls. Publicly listed companies must maintain and assess internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act. Clinical trial accruals are a material estimate for most pharma companies, so they need a consistent, documented basis.
- Expense recognition. Under US GAAP, clinical trial costs are expensed as incurred under ASC 730 (G-Squared CFO), which means accruals must follow the work actually done at hundreds of sites.
- Oversight of outsourced work. ICH E6(R3) keeps ultimate responsibility with the sponsor for activities transferred to CROs and other service providers, and expects the financial aspects of each trial to be documented in agreements (ICH E6(R3), EMA Step 5).
- Global scale. A portfolio can span dozens of countries, each with its own currency, agreements and regulator, and US payments to physicians and teaching hospitals are reportable under Open Payments.
What a portfolio view needs to show
|
View |
What leadership sees |
|---|---|
|
Spend against budget |
By portfolio, therapeutic area, study, region and site |
|
Earned, invoiced and paid |
What work is done, billed and settled |
|
Accruals |
Work done but not yet invoiced, generated from activity |
|
Outstanding and ageing |
Payments due and overdue, by payee |
|
Forecast |
Projected spend and enrolment, from actual progress |
|
Upcoming finance events |
Milestone payments, invoices and expected change orders ahead |
|
Change order impact |
Whether a protocol change needs a change order, how much, and where |
How Cloudbyz CTFM delivers it
1. One portfolio dashboard. Payments, paid, unpaid, accrual and outstanding reports sit together at portfolio level, with drill-down to study, region, site and payee.
2. Accruals from real activity. Because Cloudbyz CTMS and EDC share the platform, completed visits and milestones create earned amounts and accruals in real time, giving finance a documented basis for each estimate.
3. Forecasting across the portfolio. The forecasting module projects spend and patient enrolment from actual progress, shows upcoming finance events at study and portfolio level, and models protocol amendment scenarios to show whether a change order is needed, how much, and which regions and sites are affected.
4. Region-wise finances and agreements. Sites are budgeted in local currency and reported in study currency, and every site, CRO and vendor agreement is tracked to execution, so CTMS can confirm an agreement is signed before a site is activated.
5. Payments at scale. Visit-based payments, payee splits between SMOs, institutions and investigators, and non-procedure costs with limits per unit are handled by rule, not by hand.
6. Reports without waiting. Leaders and sponsors can subscribe to reports, so periodic reporting doesn't depend on anyone assembling spreadsheets.
7. Controls and security. Approvals, role-based access and a full audit trail sit on Salesforce, with Cloudbyz describing its products as compliant with 21 CFR Part 11 and holding ISO 27001 certification.
Portfolio finance checklist for large pharma
- One dashboard for spend, accruals and outstanding across all studies
- Accruals traceable to completed visits and milestones
- Forecasts based on actual enrolment and visit pace
- Change order impact modelled before approval
- Local-currency budgets with study-currency reporting
- Agreements tracked to execution before site activation
- Scheduled reports for leadership and finance
- Approvals and audit trail on every budget and payment change
Built for organisations of every size
Cloudbyz CTFM is used by organisations ranging from emerging biotechs to large pharma, global multinationals, CROs and device companies. For large pharma, the same platform that runs one study scales to a full portfolio, with no integration needed between CTFM, CTMS, EDC and eTMF, and integrations available for ERP and other enterprise systems.
See the portfolio view
The Cloudbyz team can walk through a portfolio-level view in Cloudbyz CTFM, from spend and accruals to forecasting and change orders. Book a demo or visit cloudbyz.com.
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