🔬 Clinical Study Budget Calculator
Estimate total trial cost by enrollment & design
What Drives Clinical Study Costs
Clinical study budgets for medical devices are driven primarily by the number of patients enrolled, the number of sites, and study duration. The per-patient cost — which covers site payments, patient stipends, procedures, and data collection — typically ranges from $5,000 for simple observational studies to $30,000+ for complex interventional trials with extensive follow-up and imaging.
Site costs are often underestimated. Each site requires startup fees ($20,000-50,000), an Institutional Review Board (IRB) review, contracts, training, and ongoing site management. Adding sites accelerates enrollment but multiplies these fixed costs. A study with 5 sites and 100 patients has very different economics than 15 sites and the same 100 patients.
The Role of a CRO
Contract Research Organizations (CROs) handle study execution — monitoring, data management, regulatory submissions, and site management. A full-service CRO typically adds 25-40% to direct study costs but provides the infrastructure most startups lack. Functional or partial CRO models cost less but require more internal oversight. Running fully in-house is cheapest on paper but requires experienced clinical operations staff.
Frequently Asked Questions
How much does a typical medtech pivotal trial cost?
Pivotal device trials commonly range from $1 million to $10 million depending on patient count, follow-up duration, and complexity. IDE (Investigational Device Exemption) studies for high-risk devices sit at the higher end.
What is per-patient cost?
Per-patient cost (also called per-subject cost) is the total study cost allocated to enrolling and following one patient through the protocol. It includes site payments, procedures, patient compensation, and proportional monitoring costs.
Should I budget for screen failures and dropouts?
Yes. Plan to screen 1.2-1.5 patients for every one enrolled, and budget for a dropout rate of 10-20%. These factors meaningfully increase real-world enrollment costs above the simple per-patient figure.
Estimates are for planning only and vary widely by therapeutic area, geography, and protocol. Consult a clinical operations professional or CRO for a formal budget.