CRO CalculatorClinical trial cost estimator, Phase I-IV

Direct fees ±20%

Estimate what a CRO will quote for your clinical trial - before you go to RFP.

Results are indicative estimates from benchmark data and modelling assumptions - not a quote, and no substitute for a formal CRO proposal. Most reliable for interventional Ph I–IV multi-site studies (≥5 sites, ≥50 patients) and patient-registry RWE.

Disclaimer: no representation or warranty is given as to the accuracy or completeness of these figures, and no responsibility or liability is accepted for any decision, negotiation position, commitment or loss arising from their use. Users remain responsible for verifying all costs directly with their CRO before contracting.

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Sponsor profile

Your organization - direct-fee adjustment for sponsor-scale negotiating leverage

Target CRO tier or specific vendor

📋 Your Study

Currency display only - base currency is EUR; the $ view converts at the target-year rate

Phase picks the right reference bid

Study class interventional vs observational - sets the effort profile

The numbers

# Sites

Duration months

# Patients enrolled randomised - screening assumed at 1.3× (corpus median)

# Protocol amendments

Study geography

Where will your sites be? North American sites cost considerably more than European ones - one of the biggest levers on your total. Pick the closest match; fine-tune later in Advanced refinements.
US = United States & Canada · EU = Western Europe (UK included)

Study design

Interventional trial structure interventional studies only - disabled for observational

Services

Untick services you'll handle in-house - they reduce to ~10% (CRO support only). Set complexity per service: Low / Medium / High.

ServiceComplexity

Clinical Operations

Project Management

Data Management

Biostatistics

Regulatory Affairs

Medical Monitoring

Pharmacovigilance (PV)

Medical Writing

Quality Assurance

⚙️ Advanced refinements (for more accuracy)

Therapeutic area

Is this an oncology study? affects site monitoring cost

Oncology trials spend a noticeably larger share of the budget on site monitoring than other therapeutic areas. Choosing "No" lowers the monitoring cost only - every other cost line stays the same. Applies to interventional studies; for observational studies, monitoring is already set by the study class you chose above.

More drivers

# Countries

Average cycles per patient

Site geography (regional CRA rates apply per zone)

Monitoring cost varies substantially by region - North America is the most expensive, Western Europe mid-range, and Eastern Europe materially lower. The regional mix you set below drives the site-facing labour cost.

Sponsor type sets the default regional site mix

Regional sites are auto-distributed from your total # sites and sponsor type - edit any field to override.

# US/Canada sites

# W. Europe sites

# E. Europe sites

Patients per region optional - blank = pro-rata to sites

Where patients actually enrol. Drives investigator-fee geography and the monitoring-rate blend. Leave blank and the total enrolled is split pro-rata across the site mix above.

# US/Canada pts

# W. Europe pts

# E. Europe pts

Site fee market (FMV percentile)

What FMV percentile will the sponsor pay?

FMV = Fair Market Value benchmark for investigator fees. 90th-pct adds ~25% over typical.

Investigator fees, auto-calculated from phase, site geography and FMV percentile.

Completed €71,000 · Drop-out €36,000 · Screen-fail €3,100

Calibrated on oncology. For non-oncology studies it runs high, roughly 1.5 to 2.5 times.

Replace with the protocol’s actual per-patient grant:

Completed Drop-out Screen-fail

Activity-level overrides leave blank = use phase defaults

Benchmarked unit costs. Filling these tightens accuracy on DM, Clinical Mgmt, PV, Biostats.

# eCRF pages (total)drives DM

# IMVs (total)drives Clin Mgmt CRA

# SAEs (total)drives PV

# Tables+Listings+Figuresdrives Biostats

🔬 Super-advanced (for CRO bid review) - fine-grained DM + Biostats inputs

For maximum accuracy when comparing CRO bids. Each unique-page / IA / freeze adds explicit dollar cost on top of the lumped activity inputs above.

# Unique eCRF pagesDM build, €500/page

# Edit checks (programmed)DM build, €250/check

# Interim analysesBiostats, €100k each

# Database freezes/locksDM+Biostats, €20k each

# Dry runsBiostats, €40k each

# Database transfers (SDTM)DM, €7k each

Inflation timing

Reference year

Target bid year

Budget Distribution

Direct

Direct Fees ±20%

Inv. Fees ±25%

PTC (excl IF) ±25%

Grand Total ±20%

Your quote doesn’t match this range?

Twenty minutes now, or a change order in month eight.

I rebuild the budget against real cost data and run the RFP, so the number you sign is one the study can actually be delivered on. No documents needed.

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💼 CRO direct fees by service line

Service line	% of total	Your forecast

💰 Pass-through costs breakdown indicative

Service line	% of total	Your forecast

Investigator fees are the largest component here - typically 60-80% of this total. Every line is indicative.

🏢 What different CROs would likely bid

Same study, priced at each CRO tier. Indicative - a specific vendor’s bid will vary with scope and relationship.

What this clinical trial cost calculator does

CRO Calculator estimates what a contract research organisation is likely to quote for a clinical trial, before you go to RFP. It covers interventional Phase I to Phase IV studies and patient-registry RWE, across oncology, neurology, rare disease and other therapeutic areas.

A clinical trial budget is estimated in the three parts that behave differently: CRO direct fees by service line, pass-through costs, and investigator fees. Direct fees are the part you negotiate, and the part the model estimates most closely, to within about 20%.

It is built for sponsors, clinical operations and procurement teams who want an independent benchmark of CRO costs before a bid defence. Free, no login, no email.

Figures are indicative estimates from benchmark data and modelling assumptions. They are not a quote and not a substitute for a formal CRO proposal.