About this sample. This page shows the method and structure of the report. It contains no client data; every engagement is prepared for the specific study and indication.
1Overview
A bottom-up estimate of study cost built from a documented cost library. Every line states its cost type, quantity, rate and evidence grade, so totals can be traced, compared across scenarios and reconciled with external proposals.
2Questions this report answers
- ?What should the study cost, split by cost type and category?
- ?How strongly do the number of sites and enrollment drive the total?
- ?What does each month of delay add to the budget?
- ?How do CRO or site proposals compare with an independent estimate?
3Protocol
The report follows the same documented sequence for every study. Each step produces an output that is kept in the final report.
- 1
Study parameters
Sites, enrollment, duration and the schedule of assessments are taken from the protocol and confirmed with you.
Output: Parameter sheet
- 2
Cost structure
Every cost is classified as per-site, per-patient, fixed or time-dependent, so it scales correctly with the study design.
Output: Cost structure
- 3
Rate assignment
Rates are taken from the cost library for the indication, each with its basis and evidence grade.
Output: Costed line items
- 4
Scenarios
Low, base and high scenarios are built from the same structure so differences can be read line by line.
Output: Scenario comparison
- 5
Cost of delay
The extra cost of each delayed month is calculated from the monthly running cost and extension management.
Output: Delay cost
- 6
Proposal reconciliation
If provided, CRO or site proposals are mapped to the same structure and compared line by line.
Output: Gap analysis
4Report contents
| Section | Title | What it contains |
|---|---|---|
| 1 | Executive summaryTotal by scenario and the main cost drivers. | Total by scenario and the main cost drivers. |
| 2 | Budget by cost typePer-site, per-patient, fixed and monthly costs. | Per-site, per-patient, fixed and monthly costs. |
| 3 | Budget by categoryTotals by cost category across the study. | Totals by cost category across the study. |
| 4 | Scenario comparisonLow, base and high side by side. | Low, base and high side by side. |
| 5 | Cost of delayAdditional cost for each month beyond plan. | Additional cost for each month beyond plan. |
| 6 | Proposal comparisonDifferences against external proposals, where provided. | Differences against external proposals, where provided. |
5Evidence standards
Every figure in the report carries its source, its date and one of four evidence grades, so you can see what is confirmed and what is assumed.
Confirmed
Reported directly by an authoritative source.
Documented
Published or documented, with a clear method.
Estimated
Derived by Clinovia from graded inputs.
Assumed
An explicit assumption, open to review.
6Inputs and deliverables
What we need from you
- Protocol synopsis and schedule of assessments
- Planned sites, enrollment and duration
- CRO or site proposals, optional
What you receive
- Written report (PDF)
- Budget model (Excel)
- Walkthrough session with your team
Discuss this report for your study
Tell us about the indication and the decision in front of you. A pilot on a single study is a good place to start.
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