How Cloudbyz CTFM Keeps Leadership and Sponsors Informed on Enrollment, Spend and Change Orders

In a Tufts CSDD analysis of nearly 16,000 sites, 11% of sites in a typical trial enrolled no patients and 37% under-enrolled (Tufts CSDD via Fierce Biotech). A 2022 Tufts CSDD survey found that 76% of protocols have at least one amendment (Tech Funding News, citing Tufts CSDD). Each of those changes moves the financial forecast.

Senior management and sponsors rarely see those changes as they happen. Enrollment is tracked by operations, spend by finance and change orders by vendor management, and each is reported on its own schedule. By the time the numbers reach a leadership review or a sponsor meeting, they describe last month. Forecasting enrollment, spend and change orders together, from live study data, gives both audiences the same picture, earlier.

Three forecasts that belong together

These are not three separate questions. Enrollment drives visits, visits drive spend, and amendments change both. A forecast that links them shows the knock-on effect of any change.

What senior management needs to see

• Portfolio view first: spend and forecast across all studies, with the ability to drill into one.
• Variance with a reason: not just that a study is over forecast, but whether it is enrollment pace, an amendment or a site issue.
• Upcoming finance events: milestone payments, invoices due and expected change orders in the next quarter.
• Cash timing: when money will go out, not only how much.

What sponsors need to see

For CROs and service providers, the sponsor is the audience. ICH E6(R3) Annex 1, section 3.6.8 states that sponsors should have access to service providers' performance metrics for selection and oversight (ICH GCP, E6(R3) Section 3). In practice, sponsors expect:

• Enrollment against plan, by country and site
• Spend against contract, including pass-through costs
• Change order impact, forecast before approval
• The same numbers the CRO is using, not a separately prepared report

How to keep both audiences informed

• Forecast enrollment from actual pace by site, not the original plan
• Link enrollment and visit forecasts to the financial forecast
• Model amendments before change orders are requested
• Give leadership a portfolio view with drill-down
• Give sponsors controlled access to the same forecast
• Show upcoming finance events for the next quarter
• Review forecast changes on a set schedule, with reasons recorded

What this means by role

• Senior management and finance leadership: one forecast across studies, with reasons for every variance.
• Clinical operations directors: enrollment and spend shown together, so timeline risks have a cost attached.
• Study finance leads: fewer separately prepared reports for leadership and sponsors.
• CRO project and account managers: sponsors see the same forecast you use, which builds trust in change order discussions.

How Cloudbyz CTFM does this

Cloudbyz Clinical Trial Financial Management (CTFM) is built natively on Salesforce on the same platform as Cloudbyz CTMS and EDC, so enrollment, visits, milestones, budgets and payments share one data model. The CTFM forecasting module uses actual study progress to forecast patient enrollment and spend, and models scenarios to show whether a change order is needed, how much, and which regions and sites are affected, then tracks spend against it. The Financial Navigator, an Agentforce agent, lets leaders ask questions such as where a study's spend stands or which invoices are ageing, in plain language. It is read-only and never changes records.

See the forecast your leadership and sponsors would see

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