By Julio G. Martinez-Clark
CEO, bioaccess®
General information, not a quote. Every figure is either an official fee linked to the regulator, or a planning range from bioaccess® budgets and our rate card, marked “bioaccess® experience”. The worked examples are small first-in-human medical device studies run in Costa Rica, El Salvador, Panama or Chile. For drug trials and for complete budgets in other countries, confirm with us. All amounts are in US dollars unless noted. Official fees checked 29 October 2026; bioaccess® figures come from our 2026 budgets.
In this guide: The short answer · How a budget is built · Line by line · Two sample budgets · What one more month, subject or site adds · What changes by country · Official fees by country · Per-patient site cost · Mexico and Colombia start-up · What you can negotiate · Comparing quotes · Checklist · Glossary · FAQ
The short answer
A first-in-human device study budget in Latin America has three parts: site costs (paid to the hospital and investigator), CRO professional fees (project management, monitoring, regulatory, data, reporting) and third-party costs (insurance, translations, import, couriers, regulator fees). Everything is priced from the protocol’s schedule of events.
In our illustrative samples, a 20-subject minimally invasive device study at one site comes to about $433K to $735K over about 15 months, and a 10-subject surgical implant study to about $839K to $1.32M over about 20 months (bioaccess® experience). The biggest swing is the per-subject site payment, which depends on the procedure. The fixed official fees we list below are small next to these totals. Costa Rica’s levy is different: it is 3% of the total study budget.
How a clinical trial budget is built
| Part | What it covers | How it is priced | Who controls it |
|---|---|---|---|
| Site costs | Investigator and coordinator time, procedures, hospital and operating room, tests | Per subject and per visit, from the schedule of events | Negotiated with each site; paid at cost and auditable against the site’s invoices |
| CRO professional fees | Start-up, submissions, project management, monitoring, data, safety, report | Rate card: per site, per month, per visit or per deliverable | The CRO; this is where scope and fees can move |
| Third-party costs | Insurance, translations, regulator and ethics fees, import, freight, travel | At cost, with a handling fee | The market; the CRO can negotiate vendors but not reprice them |
A handling or administration charge on third-party costs is common. Ask any CRO to show it as a separate line.
The budget, line by line
Ranges are for one site, from the two samples below (bioaccess® experience). Lines and totals are rounded separately, so the lines may not add up exactly to the totals.
| # | Line item | What it covers | How it is priced | Sample A: minimally invasive device (20 subjects) | Sample B: surgical implant (10 subjects) |
|---|---|---|---|---|---|
| 1 | Study design review, kick-off and site feasibility | Protocol review, feasibility, pre-study visits | Rate card | about $38K | about $38K |
| 2 | Site budget and contract | Negotiating the site budget and agreement | Rate card, per site | $9K–$13K | $9K–$13K |
| 3 | Ethics and regulatory submissions, translations, import permit | Dossier, translations, submissions, answers to questions | Rate card | $53K–$61K | $53K–$61K |
| 4 | Legal representative and importer of record | Local legal presence and import responsibility | Monthly | $8K–$9K | $11K–$12K |
| 5 | Site initiation and training | Initiation visit, training, activation | Rate card, per site | about $18K | about $21K |
| 6 | Trial master file management | Keeping the study file inspection-ready | Monthly, per site | $5K–$6K | $7K–$9K |
| 7 | Product import and logistics | Import filing support, broker coordination, delivery | Rate card | $4K–$13K | $4K–$13K |
| 8 | Project management and monitoring | Ongoing management and remote and on-site oversight | Per site-month | $48K–$65K | $88K–$115K |
| 9 | Interim and close-out monitoring visits | On-site visits | Per visit | $14K–$23K | $24K–$34K |
| 10 | Safety, status reports and site closure | Safety reporting, status reports, closure | Rate card | $22K–$32K | $22K–$32K |
| 11 | Data system build and training | Building the study on the sponsor’s licensed data system | Rate card; licence not included | $16K–$18K | $16K–$18K |
| 12 | Medical monitor | Medical oversight through enrollment and follow-up | Monthly retainer | $32K–$38K | $49K–$56K |
| 13 | Serious adverse event handling | Processing and reporting each event | Per event | $0–$10.5K for 0–3 events | $0–$10.5K for 0–3 events |
| 14 | Clinical study report | Statistical analysis plan, data cleaning, tables and the full report | Per report, by study design and size | $35K–$50K | $35K–$50K |
| 15 | Per-subject site payments | Investigator, coordinator, procedures; operating room and facility for implants | Per subject and visit | $52K–$185K | $321K–$604K |
| 16 | Site payment management | Paying sites and reconciling invoices | Percentage of site payments | $10K–$37K | $59K–$93K |
| 17 | Third-party costs at cost | Insurance, ethics and regulator fees, freight, travel | At cost | $20K–$48K | $20K–$58K |
| 18 | Handling on third-party costs | Administering third-party payments | Percentage | $4K–$10K | $4K–$12K |
| 19 | Contingency | Reserve for scope changes | Percentage of lines 1–14 | $45K–$59K | $57K–$72K |
Rates behind the lines (bioaccess® experience; rate card v2026.13, subject to change):
- Project management and monitoring: $4,750 per enrolling site-month for minimally invasive device studies and $7,750 for surgical implant studies. Follow-up months are billed at a separate rate.
- Medical monitor: $3,500 per month.
- Serious adverse events: $3,500 per event.
- Site payment management: 20% of the first $250K of site payments and 12% above that.
- Other third-party costs: 20% handling.
- Contingency: 15% of professional fees (lines 1–14).
- Clinical study report: the $35K–$50K range covers a single-arm study of up to 30 subjects at one or two sites. For larger or randomized studies, confirm with us.
Two sample budgets
| Sample A: minimally invasive device | Sample B: surgical implant | |
|---|---|---|
| Subjects and sites | 20 subjects, 1 site, 1-month follow-up | 10 subjects, 1 site, 6-month follow-up |
| Duration | about 15 months | about 20 months |
| Sample total | $433K–$735K | $839K–$1.32M |
| Costa Rica only: add the 3% levy | $13K–$22K | $25K–$40K |
| Sample total if run in Costa Rica | $446K–$757K | $864K–$1.36M |
| Two-site version | about $505K–$865K | about $930K–$1.48M |
bioaccess® experience. Illustrative, not a quote.
Assumptions:
- Countries: the samples are built for Costa Rica, El Salvador, Panama or Chile. Regulatory start-up in Mexico or Colombia costs more; see below.
- Schedule: about 4 months of start-up. Enrollment runs at about 2.5 subjects per site per month (device) or 1.25 (implant), with a 3-month minimum. Follow-up is 1 month (device) or 6 months (implant), then about 2 months of close-out and reporting.
- Monitoring and safety: about 30% screen failures; an interim monitoring visit about every 2 active months per site (at least 4); up to three serious adverse events.
- Excluded: the data system licence, the product, core labs, independent safety committees, taxes and currency movements.
Full line codes and a month-by-month timeline: sample budget.
What one more month, subject or site adds
bioaccess® experience; rate card v2026.13:
- One more enrolling month: another site-month of project management and monitoring ($4,750 device or $7,750 implant per site), another month of the medical monitor ($3,500), and another month of the legal representative and trial master file.
- One more subject: another per-subject site payment (about $2K–$11K device or $32K–$60K implant), plus the site payment management percentage.
- One more site: another round of feasibility, contracting, ethics submission, initiation, monitoring and closure. A second site shortens enrollment but adds cost; compare the one-site and two-site totals above.
What changes by country
The line items are the same everywhere. These lines change by country:
| Line | What changes | Countries where it matters |
|---|---|---|
| Regulator and ethics fees | Published fees differ. Costa Rica charges a 3% levy on the whole budget | All; see the fee table |
| Per-subject site payments | Hospital, operating room and investigator rates | Every country; quote per site |
| Translations | Spanish in most countries; Portuguese in Brazil | Brazil needs a separate language set |
| Trial insurance | Local policy or certificate, priced by the insurer | Every country; see our insurance guide |
| Import | Permit route, broker and duties | Every country; see the import guide |
| Legal representative | Whether a local representative is required, and for how long | Confirm with us per country |
| Taxes and currency | Value-added tax on services, and site contracts in local currency | Confirm with us per country |
| Timeline | More months mean more monitoring and management months | Countries with sequential or long reviews; see the site activation guide |
Official regulator and ethics fees by country
| Country | Published fee | Official source |
|---|---|---|
| Costa Rica | CONIS levy (canon) of 3% of the total study budget, paid when the approved project is registered. The law’s exemptions do not apply to studies sponsored by for-profit organizations. Each accredited ethics committee sets its own review fee. | Ley 9234, arts. 60–61 |
| El Salvador | SRS clinical trial project evaluation $2,040; annual renewal or substantial amendment $60. | SRS fee schedule |
| El Salvador | CNEIS first ethics review US$2,400 for international pharmaceutical companies. For the category that applies to a device study, confirm with us. | CNEIS manual |
| Panama | CNBI, sponsored studies: new protocol B/.1,500 per protocol; amendment B/.800; additional site B/.500 per site; annual renewal B/.800 per site (the balboa trades at par with the US dollar). Institutional committees publish their own fees. | CNBI PT-011A |
| Ecuador | ARCSA import authorization for trial products US$150.24. Other fees: confirm with us. | ARCSA import procedure |
| Peru | DIGEMID’s import authorization procedure lists no fee. The page shows the online service disabled since 20 August 2026, so confirm the current filing route and fee with us. Freight, broker and duties are separate. | gob.pe DIGEMID procedure |
| Chile | ISP authorization is required for provisional use of an unregistered product. ISP fee and the applicable code: confirm with us. Ethics committee fees vary by committee. | ISP |
| Brazil, Colombia, Mexico, Argentina, Dominican Republic, Guatemala, Uruguay | Confirm with us. | — |
Per-patient site cost
From our 2026 budgets (bioaccess® experience). These are per-subject site payments, the same basis as line 15:
| Study type | Per-subject site payment |
|---|---|
| Minimally invasive device | about $2K–$11K |
| Surgical implant, including operating room and facility time | about $32K–$60K |
By procedure type (bioaccess® experience, de-identified across programs). These are site clinical costs per patient, including site overhead and excluding CRO fees and the product, so the basis differs from the table above:
| Procedure type | Per-patient site cost |
|---|---|
| Ophthalmology, outpatient implant | about $13K |
| Orthopedics, surgical implant (inpatient) | about $25K–$28K |
| Peripheral vascular or endovascular, cath lab | about $23K–$38K |
Regulatory start-up cost: Mexico and Colombia
bioaccess® experience. Our regulatory start-up-to-approval package starts at about $188K in Mexico and about $305K in Colombia, roughly 1.6 times Mexico. In our experience, Colombia’s package includes an additional INVIMA technical-dossier step. These are package starting points, not a matched-protocol comparison. They exclude the product, trial insurance and the study after approval. For your scope, confirm with us. bioaccess® runs first-in-human studies in Colombia now.
What you can negotiate and what you cannot
| Item | Negotiable? | Notes |
|---|---|---|
| CRO professional fees | Yes | Scope, staffing and fee structure can be discussed |
| Third-party vendor costs | Limited | The CRO can negotiate vendors but cannot reprice the market |
| Site and hospital payments | When the site contract is negotiated | Then paid at cost and auditable against invoices |
| Advance payment | Usually not | Common in study start-up: contracting, imports and translations are paid before enrollment |
| Official fees and levies | No | Set by the regulator or the law |
Where sponsors can save without hurting time or data quality: freeze the schedule of events before the quote, negotiate site payments at contract stage, and right-size statistics, translations and data hosting. Monitoring, data management and regulatory compliance are poor places to cut in a first-in-human study.
How to compare CRO quotes
| Ask | Why |
|---|---|
| Is every line in the table above included, and which are excluded? | Totals are not comparable if one quote leaves out the site payments or the report |
| How are site payments and third-party costs marked up? | Handling fees should be visible as lines |
| How many monitoring months are assumed? | Slow enrollment adds months of fees |
| What screen-failure rate and enrollment pace are assumed? | They drive the site payments and the duration |
| Which country fees and levies are included? | Costa Rica’s levy alone is 3% of the total |
| What triggers a change order? | Amendments, extra visits and longer enrollment change the budget |
| What is the payment schedule? | An advance payment is common in study start-up |
Budget checklist
- ☐ Final schedule of events sent with the request for a quote
- ☐ Country and number of sites chosen
- ☐ Screen-failure rate and enrollment pace agreed
- ☐ Site payments quoted per visit, including operating room and hospital time
- ☐ Insurance quote requested
- ☐ Import route and broker priced
- ☐ Official fees and levies listed per country
- ☐ Excluded items listed
- ☐ Contingency agreed
- ☐ Change-order triggers and payment schedule agreed
Glossary
- Schedule of events: the visit-by-visit list of procedures in the protocol; the basis of every budget.
- Pass-through: a cost the CRO pays for the sponsor and bills at cost, auditable against the invoice.
- Site-month: one month of activity at one site; the unit for management and monitoring fees.
- Screen failure: a person screened who does not enroll.
- Contingency: a reserve for changes in scope.
- CONIS levy (canon): Costa Rica’s charge of 3% of the total study budget, paid when the approved study is registered.
- Importer of record: the local party legally responsible for bringing the product into the country.
Frequently asked questions
How much does a first-in-human medical device trial cost in Latin America?
In our illustrative samples, about $433K to $735K for a 20-subject minimally invasive device study at one site, and about $839K to $1.32M for a 10-subject surgical implant study (bioaccess® experience). Your protocol sets the real number. For drug trials, confirm with us.
Which line moves the budget most?
Per-subject site payments. In our 2026 budgets they ran about $2K to $11K per subject for minimally invasive devices and $32K to $60K for surgical implants, including operating room time (bioaccess® experience).
Which country is cheapest?
It depends on the site, the procedure and the timeline, so compare study-specific budgets. Among the fees we list, the fixed ones are small next to a study total. Costa Rica’s levy is 3% of the total study budget.
Are regulator fees a big part of the budget?
The fixed fees we list are not. For example, Panama’s national bioethics committee charges B/.1,500 for a new protocol, and El Salvador’s regulator charges $2,040 to evaluate a clinical trial project. Costa Rica’s 3% levy grows with the budget.
What do these sample budgets exclude?
The data system licence, the product, core labs, independent safety committees, taxes and currency movements. Confirm inclusions and exclusions in each CRO proposal.
How much does one more month of enrollment cost?
In our samples, another site-month of management and monitoring ($4,750 for device studies or $7,750 for implant studies per site), plus $3,500 for the medical monitor and another month of the legal representative and trial master file (bioaccess® experience).
Is this a quote?
No. The figures are illustrative planning ranges and official fees. We prepare a budget for each study.
Get a budget for your study
Send us your synopsis and schedule of events. We will return a line-by-line budget by country. Contact bioaccess®.
Related reading: Sample budget · Budget drivers · Site activation timeline · Importing investigational drugs and devices · US vs Canada vs Latin America for first-in-human · Clinical trial insurance by country
Sources
- Costa Rica: Ley 9234, Ley Reguladora de Investigación Biomédica, arts. 60–61
- El Salvador: SRS fee schedule (2025); CNEIS operating manual
- Panama: CNBI fee schedule PT-011A
- Ecuador: ARCSA import of investigational products
- Peru: DIGEMID import authorization procedure
- bioaccess® rate card v2026.13 and 2026 study budgets (internal; de-identified)