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.
Assumptions behind these samples
- Minimally invasive device: catheter-based, wearable or diagnostic device with a short procedure. Surgical implant: permanent implant placed in an operating room (OR) or cath lab, such as a valve, stent graft or neurostimulator, with anesthesia, a hospital stay and longer follow-up.
- Subjects and sites: Sample A has 20 subjects; Sample B has 10. Each is shown at one site, with a two-site variant. About 30% screen failures are allowed for.
- Duration: about 4 months of start-up, then enrollment at a planning pace of about 2.5 subjects per site per month (minimally invasive device) or 1.25 (surgical implant), with a 3-month minimum. Follow-up is 1 month (minimally invasive device, 30-day primary endpoint) or 6 months (surgical implant), then about 2 months of close-out and reporting.
- Visit schedule: screening, procedure and protocol follow-up visits paid per subject to the site; an interim monitoring visit about every 2 active months per site (at least 4), plus close-out visits.
- Included: per-subject site payments; site payment management (K.1) at 20% on the first $250K of site payments and 12% above; pass-throughs at cost (insurance, ethics and authority fees, freight, travel) with 20% handling (C.16); medical monitor retainer; up to three serious adverse events; a clinical study report; and a 15% contingency on professional fees.
- Excluded: the EDC license, the device itself, core labs, and independent safety committees (DSMB, data safety monitoring board, or CEC, clinical events committee). Taxes and currency movements are also excluded.
- Costa Rica: the 3% CONIS levy is shown as a separate line under each sample table and applied the same way by the estimator when Costa Rica is selected. Costa Rica is the only country in Latin America with such a levy.
Estimate a range for your study
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.
Sample line-item budgets
Sample A: minimally invasive device, 20 subjects, one site
| 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 |
Sample B: surgical implant, 10 subjects, one site, 6-month follow-up
| 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.
What drives the cost
- Per-subject site payments. In our 2026 budgets these ran about $2K–$11K per subject for minimally invasive devices and $32K–$60K for surgical implants, which include operating room (OR) and facility time. This is the largest single swing.
- Monitoring months. Project management and monitoring are billed per active site-month: $4,750 for minimally invasive device studies and $7,750 for surgical implant studies. Slow enrollment costs money every month.
- Follow-up length. Each extra month keeps a site, the legal representative and trial master file (TMF) management running.
- Number of sites. Each site adds feasibility, contracting, an ethics submission, initiation and closure.
- Third-party handling. Site payments carry a 20% management fee on the first $250K (12% above that), and other pass-throughs carry 20%. Both are shown openly in the tables above.
- Clinical study report (CSR). For a single-arm study of up to 30 subjects at one or two sites, the report (statistical analysis plan, data cleanup, tables, listings and figures, and the full report) is budgeted at $35K–$50K. Larger or randomized studies of about 31–75 subjects move to $55K–$75K.
Illustrative month-by-month timeline (Sample A)
| 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.
Official regulator and ethics fees
| 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.
What’s not included, and costs that often surface later
- EDC license (we build and train on the sponsor’s licensed system), the device itself, core labs, and independent safety committees (a data monitoring committee or clinical events committee).
- Protocol authoring and medical writing beyond the CSR.
- Hospital stays beyond the protocol and unscheduled visits. The sample allows for up to three serious adverse events (SAEs) at $3,500 each; more are billed per event.
- Screen failures above plan, extra pre-study visits, amendments, and months added by slow enrollment.
- Taxes and currency movements on site contracts in local currency. (Costa Rica’s 3% levy is shown separately under each sample table.)
Ask any CRO which of these are in its number before you compare totals.
Frequently asked questions
Is this a fixed price?
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.
Why are surgical implant studies so much more expensive?
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.
What official fees should I expect?
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.
Does running an FIH study in Latin America mean the device is FDA-approved?
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.
Is EDC included?
We build and train on an electronic data capture (EDC) system the sponsor licenses. The license itself is not included or priced.
How long might a study take?
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.
Get a custom budget
Send us your protocol synopsis, and we’ll prepare a fitted budget and timeline for Costa Rica, El Salvador, Panama or Chile.
Glossary
- CEC / CBI / CNBI / CNEIS: ethics committees (scientific-ethics committee; institutional bioethics committee; Panama’s national bioethics committee; El Salvador’s national health research ethics committee).
- CONIS: Costa Rica’s national health research council. SRS: El Salvador’s health regulator.
- Minimally invasive device: catheter-based, wearable or diagnostic, short procedure. Surgical implant: permanent implant placed in an OR or cath lab (e.g. valve, stent graft, neurostimulator), with anesthesia, hospital stay and longer follow-up.
- CRO: contract research organization. CSR: clinical study report. EDC: electronic data capture. EFS: early feasibility study. FIH: first-in-human.
- OR: operating room. SAE: serious adverse event. TMF: trial master file. FDA: US Food and Drug Administration. USD: US dollars. 21 CFR 812.28: the FDA rule on accepting clinical data from studies conducted outside the US.