In plain terms: the estimator is a set of transparent, published formulas. It multiplies the values you enter by documented base costs and adjustment factors. It does not use AI, machine learning, or any hidden model — everything that drives your number is listed on this page. Outputs are directional planning estimates only and must be validated against your own protocol, vendors, and contracts.
1. Two estimation modes
The tool offers two independent models. Sponsor / Total Trial estimates the full study cost across all sites and stakeholders. Site-level estimates the per-site cost using a Site Costs + Procedures + Personnel + Visits structure, and returns a negotiation range. Each uses its own formula, described below.
2. Currency, basis, and dating
All figures are expressed in US dollars (USD). Base costs, procedure unit costs, and personnel rates reflect US-market planning medians assembled from publicly reported industry ranges and typical contract values, current as of the July 2026 review of this page. Non-US geographies are scaled by a country cost factor (Section 5). These are planning assumptions, not a dated survey of your market; we recommend validating them against recent quotes for your specific protocol and region, and re-checking annually for inflation.
3. Sponsor / Total Trial model
The sponsor estimate is the sum of the following components. cm is the average country cost factor for the regions you select (Section 5); therapyMult and complexity are adjustment factors (Section 4).
site payments = per-patient × patients × 0.40
visits + procs = patients × (visits×$350 + bloodDraws×$60 + vials×$15 + imaging×$1,800) × cm
monitoring = sites × (months÷12) × $35,000 × (0.5 + SDV×0.5) + CRA-FTE × $180,000 × months÷12
CRO + CTM = (sitePayments + monitoring) × 0.55 + CTM-FTE × $220,000 × months÷12
regulatory = $850,000 (Ph3+) / $350,000 (Ph2) / $150,000 (Ph1)
IP supply = patients × $8,000 (Ph3+) or $4,500 (earlier)
data + biostat = patients×$1,200 + sites×$8,500 + DM-FTE×$150,000×months÷12 + Biostat-FTE×$200,000×months÷12
med writing = MW-FTE × $180,000 × months÷12 + SOPs × $4,500
overhead = 12% of the subtotal above
contingency = 10% of (subtotal + overhead)
TOTAL = subtotal + overhead + contingency
The displayed range is 0.75× to 1.35× the median total, reflecting typical planning-stage uncertainty.
4. Adjustment factors
Phase base (per-patient starting point)
| Phase | Base / patient |
|---|---|
| Phase 1 | $25,000 |
| Phase 2 | $45,000 |
| Phase 3 | $60,000 |
| Phase 4 | $30,000 |
Therapeutic-area multiplier (selected examples)
| Area | × | Area | × |
|---|---|---|---|
| Oncology — solid | 1.70 | Rare disease / orphan | 1.85 |
| Oncology — heme | 1.65 | Pediatric | 1.45 |
| CNS / Neurology | 1.40 | Cardiovascular | 1.10 |
| Immunology | 1.30 | Metabolic | 1.00 |
| Vaccine | 0.85 | Dermatology | 0.85 |
Other factors
- Decentralization: site-based ×1.00, hybrid ×0.95, fully decentralized ×0.85.
- Protocol complexity: standard ×1.00, above average ×1.25, high ×1.50.
- SDV intensity: risk-based 30%, selective 60%, full 100% — scales the monitoring component.
5. Country cost factors
Each region carries a multiplier relative to the United States (US = 1.00). When you select multiple regions, the tool averages their factors. Selected examples:
| Country | × | Country | × | Country | × |
|---|---|---|---|---|---|
| United States | 1.00 | Switzerland | 1.20 | India | 0.30 |
| Germany | 0.95 | Japan | 1.05 | Brazil | 0.55 |
| United Kingdom | 0.92 | China | 0.55 | Poland | 0.55 |
| Canada | 0.95 | Australia | 0.95 | South Africa | 0.55 |
6. Site-level model
The site estimate builds up from four blocks, then applies your site overhead rate. Selecting country + phase auto-fills defaults you can override.
procedures = patients × (blood×$60 + vials×$15 + labs×$100 + imaging×$1,800 + ECG×$75 + special×$350) × cm
personnel = patients × (PI-hrs×$300 + subI-hrs×$250 + coord-hrs×$70 + nurse-hrs×$60 + pharm-hrs×$120) × cm
visit coord = patients × visits × $150 × cm
subtotal = one-time + procedures + personnel + visit coord
TOTAL = subtotal × (1 + siteOverhead%)
Site overhead defaults to 30% (academic), selectable 20–35%. The negotiation range is 0.85× (opening) to 1.15× (ceiling) of the total.
7. Procedure & personnel unit costs
| Item | Unit cost (US) |
|---|---|
| Blood draw | $60 each |
| Vial banked | $15 each |
| Routine lab panel | $100 each |
| Imaging (MRI/CT/PET) | $1,800 each |
| ECG | $75 each |
| Special procedure | $350 each |
| Scheduled visit (site coordination) | $150–$350 each |
| Principal Investigator | $300 / hour |
| Sub-Investigator | $250 / hour |
| Study Coordinator | $70 / hour |
| Research Nurse | $60 / hour |
| Pharmacist | $120 / hour |
8. Sensitivity & how to read the range
Because early-stage budgets are uncertain, every estimate is shown as a median with a range rather than a single number. The dominant sensitivities are: phase and therapeutic area (largest effect on per-patient cost), country mix (can swing totals ±40% or more), patient and site counts (linear scaling), and visit and procedure intensity. If a small change in one input moves your total substantially, treat that input as a key negotiation lever and confirm it with a real quote.
9. Limitations
- Figures are planning medians, not quotes. Actual budgets depend on vendor selection, contract terms, protocol specifics, and negotiation.
- Non-US costs use a single country factor and do not capture site-to-site or regional variation within a country.
- The tool does not model pass-through costs in full detail, currency hedging, or amendment impact beyond the inputs provided.
- This is not financial, legal, or regulatory advice. Have outputs reviewed by qualified finance and clinical operations staff before use in contracting.