The most reliable site budget is built directly from the protocol's schedule of assessments, so every visit and procedure has a line and a fee. Cloudbyz CTFM builds site budgets against the study visit plan held in Cloudbyz CTMS, pricing each visit and procedure from rate cards, and updates the affected lines when an amendment changes the plan. It suits large pharma, global multinationals, biotechs, CROs and device companies.
How budgets are built today
- A budget analyst reads the schedule of assessments in the protocol PDF.
- Visits and procedures are typed into a spreadsheet, one row at a time.
- Fees are looked up from past budgets or rate cards.
- The spreadsheet is copied for each site and negotiated by email.
- When an amendment arrives, every copy is edited by hand.
Missed procedures, double-counted visits and out-of-date copies are common, and they surface later as invoice disputes.
Why it matters
- The agreement must reflect the protocol. ICH E6(R3) expects the financial aspects of a trial to be documented in the site agreement (ICH E6(R3), EMA Step 5). A budget that doesn't match the schedule of assessments means the agreement doesn't either.
- Protocols are becoming structured. ICH M11, issued by FDA as final guidance in May 2026, defines a structured protocol format (FDA, ICH M11), making it easier to drive budgets from the schedule rather than retype it.
Today versus Cloudbyz CTFM
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Step
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Today
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Cloudbyz CTFM
|
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Visits and procedures
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Retyped from the protocol
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Taken from the study visit plan
|
|
Fees
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Looked up manually
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Applied from rate cards and templates
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Conditional procedures
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Often missed
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Budgeted as optional lines
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Screen failures, unscheduled visits
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Added late
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Standard lines with limits
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Amendments
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Every copy edited
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New version, applied to affected visits
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What changes by department
- Finance and budget analysts: budgets start complete, not from a blank sheet.
- Clinical operations: the visit plan you maintain is the one finance uses.
- Contracts teams: negotiation starts from a budget that matches the protocol.
- Sites: every procedure they perform has a line, so fewer disputes later.
How Cloudbyz CTFM does it
Cloudbyz CTFM is built natively on Salesforce with Cloudbyz CTMS and EDC. Study visit plans in CTMS drive site budgets in CTFM, fees come from MSAs, rate cards and templates, and completed visits in EDC generate earned amounts against the same lines. Book a demo or visit cloudbyz.com.
