Draft Estimate
$1,732,645
Study Start-Up, Regulatory / Ethics, Clinical Monitoring, Project Management, Safety / Medical Monitoring, Data Management, Biostatistics, Medical Writing, Patient Recruitment, Quality Assurance
Estimate is displayed in AUD. Discount applied: 0% (Services only). Optional and excluded services should be agreed before sponsor issue.
Closest Comparators
| Approved WO | Phase | Sites | Participants | Total | Delta |
|---|---|---|---|---|---|
| BIOLEXIS AU PTY LTD | 1 | 1 | 60 | $1,368,564 | $364,081 |
| EnGeneIC Pty Limited | 1/2a | 1 | 30 | $2,155,442 | -$422,797 |
| Navigator Medicines | 1 | 1 | 70 | $2,130,091 | -$397,446 |
| Myopharm Limited | 2a | 3 | 30 | $1,569,882 | $162,764 |
Assumptions Register
Study Start-Up estimated from the selected approved WO benchmark and adjusted for current study drivers.
Study Start-UpRegulatory / Ethics estimated from the selected approved WO benchmark and adjusted for current study drivers.
Regulatory/EthicsClinical Monitoring estimated from the selected approved WO benchmark and adjusted for current study drivers.
Monitoring & Site VisitsProject Management estimated from the selected approved WO benchmark and adjusted for current study drivers.
Study Management, Project Teleconferences, Project Administration OversightSafety / Medical Monitoring estimated from the selected approved WO benchmark and adjusted for current study drivers.
Local Safety Reporting & Medical MonitoringData Management estimated from the selected approved WO benchmark and adjusted for current study drivers.
Data ManagementBiostatistics estimated from the selected approved WO benchmark and adjusted for current study drivers.
BiostatisticsMedical Writing estimated from the selected approved WO benchmark and adjusted for current study drivers.
Medical WritingPatient Recruitment estimated from the selected approved WO benchmark and adjusted for current study drivers.
Participant Recruitment/ RetentionVendor Management estimated from the selected approved WO benchmark and adjusted for current study drivers.
3rd Party VendorsQuality Assurance estimated from the selected approved WO benchmark and adjusted for current study drivers.
Quality AssurancePass-through costs require fee schedules, site budgets and vendor quotes before sponsor submission.
Total Pass Through Cost EstimateProposal Summary
Southern Star Research has prepared this draft Work Order budget estimate for the sponsor based on the available Phase 1 patient study inputs and sponsor-approved historical Work Orders. The current benchmark-adjusted total is $1,732,645 including services, pass-through cost allowance, planning reserve and any entered discount.
Study Start-Up, Regulatory / Ethics, Clinical Monitoring, Project Management, Safety / Medical Monitoring, Data Management, Biostatistics, Medical Writing, Patient Recruitment, Quality Assurance
Estimate is displayed in AUD. Discount applied: 0% (Services only). Optional and excluded services should be agreed before sponsor issue.
Key dependencies include final protocol and schedule of assessments, site and participant assumptions, ethics/governance strategy, vendor model, recruitment approach, and pass-through fee confirmation.
Review assumptions, resolve clarification questions, confirm service inclusion status, then convert the estimate into the sponsor-facing Work Order and budget package.
Clarification Questions
- Confirm sponsor legal entity and billing contact for Work Order preparation.
- Confirm final protocol identifier and current protocol version/date.
- Confirm indication and any therapeutic-area specific operational constraints.