PRACTICAL GUIDE | 2026
Pass-throughs, professional fees, and the parts of a proposal you can actually change.
By Julio G. Martinez-Clark
CEO, bioaccess®
Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.
First-in-human (FIH) trial budgets in Latin America are the most-asked commercial question in our practice — and the most misunderstood. Sponsors see a single large number and ask, “Is there flexibility in that, because that’s a lot more than we were expecting to pay?” The honest answer starts with anatomy: a proposal is not one number. It is three buckets, priced from the schedule of events, with very different rules for what moves and what does not.
What does an FIH budget actually buy? The three buckets
| Bucket | What it covers | Who controls the price |
|---|---|---|
| Site costs | Hospital fees, investigator fees, procedure and per-patient costs negotiated at the clinical trial agreement (CTA) | Pass-through: negotiated with the site, audited against invoices |
| CRO professional fees | Project management (a bilingual physician PM), monitoring, regulatory submissions, data management, quality oversight | The CRO: this is where fee flexibility lives |
| Third-party costs | Biostatistics, translations, EDC and data hosting, central labs, couriers, insurance, import agents | The market: the CRO can negotiate vendors but does not set the price |
Everything is priced from the schedule of events — the visit-by-visit list of what happens to each patient. More visits, more procedures, more complexity: more budget. That is why a precise quote needs the full protocol and schedule of events, while a synopsis alone only supports a rough range.
What are pass-throughs, and how are they audited?
A pass-through is a cost the CRO pays on your behalf and bills back at cost — site and hospital payments, third-party vendor invoices. It is not margin. Sponsors audit pass-throughs against the underlying invoices: the hospital’s bill, the lab’s invoice, the translation receipt. A general and administrative (G&A) charge of roughly 10–20% over third-party costs covers the administration of those pass-throughs — the contracting, payment, reconciliation, and audit trail.
What is negotiable — and what is not?
Negotiable: the CRO’s professional fees. “Flexibility on our CRO professional fees, because that’s what we control,” as our CEO puts it. Scope, staffing model, and fee structure are all discussable. Not negotiable: third-party costs — “the third-party cost is something we don’t control,” though a good CRO influences it through vendor negotiation. And not negotiable: the advance payment. “We need to have an advance payment, otherwise we won’t be able to start — it’s standard in the industry.” Pay-as-you-go sounds attractive; it does not fund site contracting, imports, and startup work that must be paid before enrollment.
| Lever | Negotiable? | Notes |
|---|---|---|
| CRO professional fees | Yes | Scope and staffing are discussable; this is the CRO’s margin |
| Third-party vendor costs | Limited | CRO can negotiate vendors, but cannot reprice the market |
| Site / hospital payments | At CTA | Negotiated with the site during contracting; then pass-through at cost |
| Advance payment | No | Standard in the industry; startup cannot be funded without it |
Where can you cut without sacrificing time or data quality?
Sponsors ask this constantly: “What areas could we cut in the proposal without sacrificing time and data quality?” Real answers from real programs:
- Right-size statistics, translations, and EDC/data hosting — typically a $40,000–$50,000 cluster. Trim scope and redundancy, not the functions.
- Self-monitoring: in one program the sponsor took monitoring in-house. It was a legitimate cut because the sponsor had the capability — but it only works if you truly do.
- Negotiate site and hospital payments hard at the CTA stage. They are pass-throughs, so every dollar negotiated is a dollar saved.
- Freeze the schedule of events before quoting. Scope creep after the proposal is the most expensive line item of all.
- Question multi-country designs on cost grounds — but keep them when the timeline needs the insurance. Do not cut the thing that protects your critical path.
What does 8 patients in Panama cost?
A recent 8-patient FIH in Panama came in around $300,000, including hospital fees. The hospital fees are a pass-through expense — negotiated at the CTA, billed at cost, auditable against invoices. That number is a reference point, not a price list: patient count, visit structure, procedure complexity, and country all move it. But it shows the shape of a real LATAM FIH budget — and why the three-bucket anatomy matters more than any single number.
Frequently asked questions
Q: Is there flexibility in an FIH proposal?
A: On the CRO’s professional fees, yes — that is what the CRO controls. Third-party costs can be influenced through vendor negotiation but not repriced; the advance payment is standard and non-negotiable.
Q: Can we do pay-as-you-go instead of an advance payment?
A: No. Site contracting, imports, translations, and startup staffing must be paid before enrollment begins. Advance payment is standard in the industry.
Q: What is the G&A charge on a proposal?
A: Roughly 10–20% over third-party costs. It covers administering the pass-throughs — contracting, payment, reconciliation, and the audit trail — not hidden margin.
Q: What can we cut without hurting time or data quality?
A: Right-size stats, translations, and EDC hosting (a ~$40–50k cluster); consider sponsor self-monitoring if you have the capability; negotiate site payments at the CTA; freeze the schedule of events.
Q: What do you need to quote our study accurately?
A: Protocol or synopsis plus the schedule of events and a feasibility questionnaire. The synopsis alone supports a rough range; precision needs the full package.
Q: What does a first-in-human trial budget in Latin America actually buy?
A: Three things: site execution, CRO professional management, and third-party services — all priced from the schedule of events, with pass-throughs audited against invoices.
First-in-human trial budgets in Latin America reward sponsors who read the anatomy, not just the total. Know which bucket each dollar sits in, know what moves and what does not, and cut scope — never quality infrastructure.
Talk with bioaccess® about your Latin America FIH strategy
Send us your synopsis and schedule of events. We will return a three-bucket budget — site, CRO, third-party — with every pass-through auditable, and tell you honestly what can move.
Talk with bioaccess® about your Latin America FIH strategy
References
- bioaccess® proposal and program data from first-in-human studies in Latin America, 2021–2026 (budget structures, pass-through auditing, CTA negotiations). Last verified: September 2026.
- Companion post: “FIH Cost in Panama or El Salvador vs the US: Use Published Clocks, Not Invented Averages” (cost-comparison angle).
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