This page walks through an illustrative scenario: a line-by-line sample budget for a typical first-in-human (FIH) medical device trial in Latin America. It is built from the bioaccess® rate card (version 2026.13) and from the ranges in the FIH and early feasibility study (EFS) budgets we prepared in 2026, with sponsor details removed. Official fees come from each regulator's published schedule.
Interactive estimator available with JavaScript enabled.
The estimator applies the same assumptions as the tables below. It returns a range, never a quote, and excludes the EDC license, the device, core labs, safety committees and taxes. Costa Rica includes the 3% levy.
| Line item (rate card code) | Sample range (USD, US dollars) |
|---|---|
| Study design review, kick-off & site feasibility (A.1–A.3) | ~$38K |
| Site budget & contract negotiation (B.1–B.5) | $9K – $13K |
| Ethics + regulatory submissions, translations, import permit (C.1–C.15) | $53K – $61K |
| Legal representative / importer of record (C.14, monthly) | $8K – $9K |
| Site initiation & training (D.1–D.6) | ~$18K |
| TMF management (D.8, monthly per site) | $5K – $6K |
| Device import & logistics (E.1–E.2) | $4K – $13K |
| Project management & monitoring (G.1/G.2 enrolling, G.3 follow-up site-months) | $48K – $65K |
| Interim + close-out monitoring visits (I.1, J.31–J.32) | $14K – $23K |
| Safety, status reports & site closure (F, H) | $22K – $32K |
| EDC build-out & training on the sponsor-licensed EDC (C.20–C.21; license not priced) | $16K – $18K |
| Medical monitor retainer (H.2, $3,500/month, enrollment + follow-up) | $32K – $38K |
| Serious adverse event handling (J.30, $3,500/event, 0–3 events) | $0K – $10K |
| Clinical study report incl. statistical analysis plan and tables (feasibility tier CSR-T1/T1+, ≤30 subjects, ≤2 sites, single-arm) | $35K – $50K |
| Per-subject site payments (investigator, coordinator, procedures) | $52K – $185K |
| Site payment management (K.1: 20% to $250K, 12% above) | $10K – $37K |
| Pass-throughs at cost: trial insurance, ethics/authority fees, freight, travel | $20K – $48K |
| Handling on pass-throughs (C.16, 20%) | $4K – $10K |
| Contingency reserve (15% of professional fees) | $45K – $59K |
| Sample total (about 15 months) | $433K – $735K |
| Costa Rica only: add CONIS levy (3% of the total study budget, applied to the sample total) | $13K – $22K |
| Sample total if run in Costa Rica | $446K – $757K |
| Line item (rate card code) | Sample range (USD, US dollars) |
|---|---|
| Study design review, kick-off & site feasibility (A.1–A.3) | ~$38K |
| Site budget & contract negotiation (B.1–B.5) | $9K – $13K |
| Ethics + regulatory submissions, translations, import permit (C.1–C.15) | $53K – $61K |
| Legal representative / importer of record (C.14, monthly) | $11K – $12K |
| Site initiation & training (D.1–D.6) | ~$21K |
| TMF management (D.8, monthly per site) | $7K – $9K |
| Device import & logistics (E.1–E.2) | $4K – $13K |
| Project management & monitoring (G.1/G.2 enrolling, G.3 follow-up site-months) | $88K – $115K |
| Interim + close-out monitoring visits (I.1, J.31–J.32) | $24K – $34K |
| Safety, status reports & site closure (F, H) | $22K – $32K |
| EDC build-out & training on the sponsor-licensed EDC (C.20–C.21; license not priced) | $16K – $18K |
| Medical monitor retainer (H.2, $3,500/month, enrollment + follow-up) | $49K – $56K |
| Serious adverse event handling (J.30, $3,500/event, 0–3 events) | $0K – $10K |
| Clinical study report incl. statistical analysis plan and tables (feasibility tier CSR-T1/T1+, ≤30 subjects, ≤2 sites, single-arm) | $35K – $50K |
| Per-subject site payments (investigator, coordinator, procedures, OR/facility) | $321K – $604K |
| Site payment management (K.1: 20% to $250K, 12% above) | $59K – $93K |
| Pass-throughs at cost: trial insurance, ethics/authority fees, freight, travel | $20K – $58K |
| Handling on pass-throughs (C.16, 20%) | $4K – $12K |
| Contingency reserve (15% of professional fees) | $57K – $72K |
| Sample total (about 20 months) | $839K – $1.32M |
| Costa Rica only: add CONIS levy (3% of the total study budget, applied to the sample total) | $25K – $40K |
| Sample total if run in Costa Rica | $864K – $1.36M |
Two-site versions of the same samples come to about $505K–$865K (minimally invasive device) and $930K–$1.48M (surgical implant). A second site shortens enrollment but adds start-up, monitoring and site-management cost.
| Month 1 | Contract, kick-off, site feasibility and pre-study visits |
| Month 2 | Site budget and contract; translations; ethics dossier |
| Month 3 | Ethics and authority submissions; import permit |
| Month 4 | Approvals (planning target); device import; site initiation |
| Month 5–12 | Enrollment (planning pace ~2–3 subjects/month at one site); monitoring visits |
| Month 13 | Last subject follow-up (30-day primary endpoint, minimally invasive device example) |
| Month 14 | Database lock; close-out visit; statistics |
| Month 15 | Clinical study report; closure report to ethics/authority |
An illustrative plan, not a commitment. Ethics committee and authority timelines are outside our control.
| Country | Published fee | Official source |
|---|---|---|
| Costa Rica | CONIS (national health research council) registration levy of 3% of the total study budget, the only levy of its kind in Latin America. Each accredited scientific ethics committee (CEC) sets its own review fee. | Ley 9234, art. 60 |
| El Salvador | SRS (health regulator) research project evaluation $2,040; annual renewal or substantial amendment $60. CNEIS (national ethics committee) initial review for international companies US$2,400. | SRS fee schedule; CNEIS manual |
| Panama | CNBI (national bioethics committee) new protocol B/.1,500; amendment B/.800; additional site B/.500; annual renewal B/.800 (the balboa, B/., trades at par with the US dollar). Accredited institutional committees publish their own fees. | CNBI PT-011A |
Rate card prices are subject to change. Fees as published when this page was prepared. Check the official source before relying on them.
Ask any CRO which of these are in its number before you compare totals.
No. It is a sample budget of a typical first-in-human (FIH) medical device trial in Latin America. Actual budgets depend on protocol, device, country and sites, and are prepared individually.
Operating room (OR), hospital stay, imaging and longer follow-up are paid per subject to the hospital. In our 2026 proposals these ranged from about $32K to $60K per surgical implant subject, against roughly $2K to $11K for minimally invasive devices.
They are small next to site and monitoring costs. Examples: Panama's national bioethics committee charges B/.1,500 for a new protocol, and El Salvador's regulator charges $2,040 to evaluate a research project. Costa Rica is the exception: its national research council levies 3% of the total study budget. It is the only country in Latin America with such a levy.
No. Clinical data from a study abroad can support a later submission to the US Food and Drug Administration (FDA) if it meets FDA's criteria under 21 CFR (Code of Federal Regulations) 812.28, but no study approves a device. An investigational device remains investigational.
We build and train on an electronic data capture (EDC) system the sponsor licenses. The license itself is not included or priced.
For a minimally invasive device with 20 subjects at one site, about 15 months is a reasonable planning assumption from contract to clinical study report (CSR): about 4 months of start-up, 8 of enrollment, 1 of follow-up and 2 of close-out. These are planning assumptions, not commitments. Ethics and authority review times are outside our control.
Send us your protocol synopsis, and we'll prepare a fitted budget and timeline for Costa Rica, El Salvador, Panama or Chile.