PRACTICAL GUIDE | 2026

Enrollment plans built from site flow, not headlines.

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.

Suggested URL slug	latam-fih-patient-recruitment-feasibility
SEO title	Patient Recruitment for FIH Trials in Latin America: Feasibility Numbers | 2026 Guide
Meta description	How FIH enrollment is really modeled in LATAM: ~1 patient/month planning, 1–3 month KOL qualification, weekly recruitment management, and backup-site strategy.
Suggested excerpt	Population statistics don't enroll patients — investigators do. Here are the feasibility numbers bioaccess® actually uses to model FIH enrollment across Latin America.

Sponsors model recruitment from population statistics. We model it from the clinic's waiting room. Patient recruitment for FIH trials in Latin America is a feasibility exercise, not a demographics exercise — and the feasibility numbers look different from the headlines. These are the planning figures behind the enrollment models we defend to sponsor boards, drawn from client questions we have answered since 2021.

• bioaccess® — a first-in-human (FIH) contract research organization (CRO) running early-stage clinical trials across Latin America.
• FIH (first-in-human) — the first clinical use of a device or drug in people — typically a small, closely monitored early-feasibility study.
• KOL (key opinion leader) — a recognized clinical expert whose practice, referrals, and reputation drive patient flow for a trial.
• First patient in (FPI) — the enrollment of the first trial participant — the milestone that starts the enrollment clock.
• Inclusion/exclusion criteria — the protocol's rules defining exactly which patients may and may not enroll.

How is enrollment actually modeled?

From actual site patient flow — the number of eligible patients the investigator sees per month — not from the country's population or the disease's prevalence. Investigator interest beats demographics: a motivated investigator with a real referral network in a mid-size city out-enrolls a disengaged department in a capital. The planning figures below come from questions sponsors have asked us across calls and email since 2021.

Milestone	Planning figure	What it assumes
KOL identification and qualification	1–3 months	Finding and vetting the right investigators in the chosen country.
Approval to first inpatient	About 1 month after approval	Regulatory approval in hand, site activated, first patient enrolled.
Steady-state enrollment	About 1 patient per month (conservative)	FIH-eligible patients under narrow inclusion/exclusion criteria.
Recruitment management cadence	Weekly	Standing meetings with the site to find and clear roadblocks.

Why is the planning rate only about one patient per month?

First-in-human inclusion and exclusion criteria are narrow by design. The eligible patient is a subset of a subset: the right diagnosis, the right anatomy, the right stage — and willing to consent to an experimental device or drug. One patient per month is the conservative planning figure we will defend to a board. Actual enrollment often runs faster, but budgets and timelines should be built on the number we can stand behind, not the number we hope for.

Does investigator interest really beat demographics?

Yes. When sponsors ask how easy it is to find another bolus of patients mid-study, the answer has three parts: it depends on the investigator, the inclusion/exclusion criteria, and the healthcare system — in that order. The investigator comes first. There is also a structural factor no population table captures: in countries where public-system access is poor, patients are forced to look for trials. Clinical research becomes a genuine care pathway, not a last resort — a real enrollment dynamic, and one more reason patient recruitment for FIH trials in Latin America rewards on-the-ground feasibility over desk research.

What happens when enrollment stalls?

Our job is to recruit patients. We meet with the site every week, find the roadblock, and clear it. Sometimes the roadblock is clinical — referral patterns, screening failures. Sometimes it is logistical — including the US proctor's schedule, which has to align with the procedure date. Weekly management is the difference between an enrollment plan and an enrollment result.

The feasibility checklist: what we confirm before quoting enrollment

• Actual patient flow at the specific site — not national prevalence figures.
• The investigator's demonstrated interest and referral network.
• KOL qualification completed (1–3 months) before activation planning begins.
• Inclusion/exclusion criteria tested against real patient charts, where possible.
• Backup sites prequalified before first patient in — activation becomes a decision, not a project.
• Proctoring schedules aligned with the procedure calendar.
• A weekly recruitment-management rhythm with named owners on both sides.

Frequently asked questions

How long does it take to qualify KOLs in the chosen country?

One to three months: identifying candidate investigators, vetting their practice and patient flow, and confirming genuine interest in the study.

When should we expect the first inpatient?

About one month after regulatory approval — approval in hand, site activated, first patient enrolled.

What enrollment rate should we plan for?

Conservatively, about one patient per month. FIH criteria are narrow by design; plan on the number we can defend, not the number we hope for.

If we need another bolus of patients mid-study, how easy is it?

It depends on three things, in order: the investigator, the inclusion/exclusion criteria, and the healthcare system. That is why backup sites are prequalified up front.

Why would poor public-system access help recruitment?

Because it forces patients to look for trials — clinical research becomes a real care pathway. Sponsors should treat these patients with the same ethical rigor as any trial population; the point is about access dynamics, not about lowering standards.

Do you manage the US proctor's schedule as part of recruitment?

Yes. Proctor scheduling is part of weekly recruitment management — a misaligned proctor is a stalled enrollment, and we treat it as our roadblock to clear.

Build your enrollment model on real site flow

bioaccess® qualifies investigators, models enrollment from actual patient flow, prequalifies backup sites, and manages recruitment weekly — across Latin America. Bring us your protocol; we will tell you what the feasibility numbers actually look like.

Talk with bioaccess® about your Latin America FIH strategyTalk with bioaccess® about your Latin America FIH strategy

References

• Planning figures in this post reflect bioaccess® client programs and sponsor Q&A, 2021–2026 (all clients anonymized).
• Related reading: “Patient Recruitment Strategies in Chile for Clinical Trials Success” (bioaccessla.com blog) — a Chile-specific companion to this LATAM-wide FIH framing.
• General: confirm enrollment planning assumptions against the final protocol and the qualified sites before committing timelines.

PRACTICAL GUIDE | 2026

When the fastest regulatory answer is that there is no registration to file.

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.

Suggested URL slug	latam-countries-no-device-registration
SEO title	The Latin American Countries Where You Don't Need a Medical Device Registration: 2026 Guide
Meta description	Some LATAM markets have no device registration system at all. Learn where import-permit-only clearance works, and where registration-holder rules kick in.
Suggested excerpt	Belize has no medical device registration system: with CE marking and ISO 13485, a simple import permit clears a device in about 1–4 weeks. Here is the counterintuitive map of where LATAM registration is — and isn't — required.

A manufacturer from India asked us about Belize. They wanted a registration strategy, a local representative, a timeline. Julio's answer was one sentence: “Belize — you don't need us here.” There is no medical device registration system in Belize. That answer surprised them, and it surprises most sponsors, because the default assumption is that every market requires a registration. It does not. The Latin American countries where you don't need a medical device registration are a small but real part of the map — and knowing which is which saves months and real money.

• bioaccess® — a first-in-human (FIH) contract research organization (CRO) running early-stage clinical trials across Latin America.
• FIH (first-in-human) — the first clinical use of a device or drug in people — typically a small, closely monitored early-feasibility study.
• Registration holder — the legal entity named on a medical device registration, responsible to the regulator for the product on that market.
• Importer of record (IOR) — the entity legally responsible for importing a product — distinct from the registration holder in most markets, identical in Panama's single-importer model.
• Reliance — a regulator's use of another trusted authority's decision — for example, a CE mark — instead of conducting a full local review.
• CE marking — the European conformity marking showing a device meets EU Medical Device Regulation requirements; widely used as reliance evidence outside Europe.
• ISO 13485 — the international quality-management-system standard for medical device manufacturers.

Do I need a medical device registration in Belize?

No. Belize has no medical device registration system. Clearance is reliance-based: CE marking plus ISO 13485 certification, processed through a simple import permit. The practical result is a one-to-four-week clearance with no dossier filing and no dossier fees. That is the whole pathway. For a manufacturer that only needs product in the country — a clinical trial shipment, a distributor's first order — the answer is refreshingly simple, and it is the clearest example of the Latin American countries where you don't need a medical device registration.

Who holds the registration in Panama?

In Panama, the Registro Sanitario must be held by a locally licensed Panamanian entity that is also the importer of record. This is the single-importer model: the holder and the importer are the same local company, and the foreign manufacturer cannot hold the registration directly. Your partner structure in Panama is therefore a regulatory decision, not just a commercial one — the registration lives with the holder, so choose that entity as carefully as you would choose a distributor.

Can the manufacturer hold the registration directly?

In Colombia, yes. Colombia is the Latin American exception: the manufacturer can hold the sanitary registration directly with INVIMA (Colombia's national food and drug surveillance institute), with no local registration-holder entity standing between the manufacturer and the regulator. Julio's operating rule follows from this: file and hold the registration in the manufacturer's name so the sponsor keeps control and can rotate distributors without re-registering. In Brazil, Mexico, and Chile, the practical answer is different — bioaccess® engages a local company to act as registration holder on the manufacturer's behalf.

The registration-holder map

Market	Who holds the registration	What it means for you
Belize	No registration system — import permit on a reliance basis (CE + ISO 13485)	Clearance in about 1–4 weeks; no dossier fees; no local holder needed.
Panama	Locally licensed Panamanian entity, also the importer of record (single-importer model)	The manufacturer cannot hold it directly; partner selection is a regulatory decision.
Colombia	The manufacturer itself — the LATAM exception	Direct control; distributors can be rotated without re-registering.
Brazil, Mexico, Chile	A local company engaged to act as holder	bioaccess® hires the local holder on the manufacturer's behalf; hold it in the manufacturer's name.

When the honest answer is “don't hire us”

The Latin American countries where you don't need a medical device registration are also a test of honesty. If your only question is how to clear a CE-marked device into Belize, you do not need a registration consultant — you need a correct import permit and clean shipping paperwork. We will tell you that directly. The sponsors who trust us most are the ones we have talked out of work they did not need.

A practical market-entry checklist

• Confirm whether the market has a device registration system at all — before building any dossier.
• If it is import-permit-only, confirm the reliance basis (CE marking + ISO 13485) and the real permit timeline — Belize runs about 1–4 weeks.
• If registration is required, confirm who may legally hold it: Panama requires a local licensed entity that is also the importer of record; Colombia allows the manufacturer directly; Brazil, Mexico, and Chile use an engaged local holder.
• Hold the registration in the manufacturer's name wherever the rules allow, so distributors can be rotated.
• Confirm import mechanics and the importer of record before quoting any timeline to your board — formal, traceable importation is required; hand-carry is at most a limited bridge, never the plan.

Frequently asked questions

Do I need a medical device registration in Belize?

No. Belize has no device registration system. Clearance is reliance-based — CE marking plus ISO 13485 certification — through a simple import permit, in about one to four weeks, with no dossier fees.

Does my CE mark work as a registration across Latin America?

No. Reliance is a pathway some markets offer; it is not a regional rule. In markets with a registration system — Colombia, Brazil, Mexico, Argentina, Chile, Panama, Peru — you still register. The CE mark supports the filing; it does not replace it.

Who can hold a device registration in Panama?

A locally licensed Panamanian entity that is also the importer of record — the single-importer model. The foreign manufacturer cannot hold it directly.

Where can the manufacturer hold the registration directly?

Colombia is the Latin American exception: the manufacturer can hold the sanitary registration directly with INVIMA.

If no registration is needed, is there anything left to get wrong?

Yes — the import paperwork. Formal, traceable importation is still required, and the permit must be filed correctly. Hand-carry is at most a limited bridge, never the plan.

How do I know whether a small market is import-permit-only?

Check with the national authority before assuming anything. The map is counterintuitive, which is exactly why the question is worth asking before you budget for a registration you may not need.

Map your registration strategy before you spend on it

bioaccess® helps medical device companies determine where registration is required, who must hold it, and where an import permit is the entire pathway — across Latin America, from Belize to Brazil. If the answer is that you don't need us, we will say so.

Talk with bioaccess® about your Latin America FIH strategyTalk with bioaccess® about your Latin America FIH strategy

References

• Belize: Ministry of Health and Wellness — medical device import-permit pathway (confirm current requirements before acting).
• Panama: Ministry of Health — Registro Sanitario, single-importer model (confirm current rules before acting).
• Colombia: INVIMA — manufacturer-held sanitary registration.
• Brazil, Mexico, Chile: registration held via an engaged local company acting on the manufacturer's behalf.
• General: agency rules change frequently; confirm the strategy with qualified regulatory counsel.

PRACTICAL GUIDE | 2026

From signed contract to first patient: realistic clocks for the fast corridor and the major markets.

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.

How long does it take to start a first-in-human trial in Latin America? It is the most-asked timeline question in FIH vendor selection — and the honest answer is that there is no single clock. Sponsors ask three versions of it: “What is your quote for the start-up duration?” “What country do you propose for the quickest completion of the FIH study and data quality?” And “How can we speed up the timeline?” This post answers all three with the clocks we actually quote.

How long does it take to start a first-in-human trial in Latin America? The country-by-country clock

Latin America splits into two speed tiers. The fast corridor — Panama, Chile, El Salvador, and Costa Rica — activates in 15 to 45 days. The major markets — Mexico, Brazil, Colombia, and Argentina — typically need 6 to 9 months. Quote by pathway, not by continent.

Country	Typical activation window	Why
Panama	15–45 days	Ethics-submission ID in about 3 business days; requirements are rare — “we barely get any requirements.” Activated in about 15 days in a real program.
Chile	15–45 days	Streamlined ethics and regulatory pathway for FIH studies.
El Salvador	15–45 days	Fast approvals; notably lower hospital fees than Panama.
Costa Rica	15–45 days	Predictable regulatory process; strong clinical infrastructure.
Colombia	6–9 months	INVIMA review plus ethics; larger patient populations and investigator depth.
Mexico	6–9 months	COFEPRIS process; large market, verify current clocks at contracting — the agency is in transition.
Brazil	6–9 months	ANVISA plus ethics; the region’s largest patient pool.
Argentina	6–9 months	ANMAT plus ethics; deep clinical research tradition.

What drives the startup clock? Four stages

Every country’s clock is the sum of the same four stages. The fast corridor is fast because each stage compresses — not because any stage is skipped.

• 1. Preparation and translation. Protocol, investigator’s brochure, informed consent, case report forms, insurance policy. The quality of the source documents sets the pace — a clean package translates and submits once.
• 2. Ethics committee cadence. How often the committee meets, and whether review runs through a hospital committee or a national body. Panama issues the ethics-submission ID in about 3 business days, with up to 30 days for requirements that rarely arrive.
• 3. Import permits. The investigational device must enter the country through formal, traceable importation. Import timelines fold into the startup clock — plan them as part of the pathway, not after it.
• 4. Parallel vs. sequential submission. In fast markets, the ethics committee and the regulator receive submissions in parallel, not one after the other. Parallel submission is a designed-in timeline accelerator, not a shortcut.

How can you speed up the timeline?

• Activate multi-site — ideally multi-country. Parallel programs in two countries hedge both timeline and recruitment risk; it is the single most effective accelerator.
• Run ethics and regulatory submissions in parallel wherever the pathway allows it.
• Submit a complete, translation-ready package the first time. Most startup delay is rework, not review.
• Pre-qualify KOLs during startup so investigator contracting does not gate first-patient-in.
• Use a CRO that has run the exact pathway before — unfamiliar teams generate the “requirements” that stall everyone else.

From activation to first patient: KOL qualification and enrollment modeling

KOL qualification — identifying, evaluating, and contracting the investigators who will actually enroll — takes 1 to 3 months and can run in parallel with regulatory startup. After approvals land, the first patient typically follows in about a month. For enrollment modeling, we are deliberately conservative: about 1 patient per month for a first-in-human, adjusted to the site’s real patient flow. Recruitment is managed weekly — site meetings every week, roadblocks cleared continuously, backup sites prequalified before they are needed.

Frequently asked questions

Q: Which Latin American country is fastest for a first-in-human trial?

A: Panama, Chile, El Salvador, and Costa Rica form the fast corridor at 15–45 days to activation. Panama is the documented extreme: about 15 days in a real program.

Q: Can you really have a trial activated in 30 days?

A: In the fast corridor, yes. The ethics-submission ID arrives in about 3 business days; requirements, when they come at all, rarely add meaningful time.

Q: What slows startup down in Brazil or Mexico?

A: Full agency review (ANVISA, COFEPRIS) plus ethics committee processes, larger dossiers, and import logistics. The trade-off is scale: deeper investigator pools and larger patient populations.

Q: Do ethics committee and regulator review happen at the same time?

A: In fast markets, yes — submissions run in parallel, which is a major reason the corridor is fast. In major markets the sequence is longer; design the pathway country by country.

Q: How long does KOL qualification take?

A: One to three months — and it should run during regulatory startup, not after it, so investigators are contracted when approvals land.

Q: How long does it take to start a first-in-human trial in Latin America if we need the fastest possible path?

A: Pick the fast corridor, activate multi-site (ideally multi-country), submit ethics and regulator in parallel, and pre-qualify KOLs during startup. That combination is how 15-day activations happen.

How long does it take to start a first-in-human trial in Latin America? Anywhere from 15 days to 9 months — and the difference is the country pathway you choose, the parallelism you design in, and the discipline of the submission. Ask for the clock by country, by stage, and in writing.

Talk with bioaccess® about your Latin America FIH strategy

Tell us your device, your patient population, and your target first-patient-in date. We will give you a country-by-country startup clock — prep, ethics, import, and enrollment — before you commit to anything.

Talk with bioaccess® about your Latin America FIH strategy

References

• bioaccess® operational data from first-in-human programs across Latin America, 2021–2026 (activation timelines, ethics cadence, KOL qualification, enrollment modeling). Last verified: September 2026.
• Country regulators referenced: Panama MINSA, Chile ISP, El Salvador, Costa Rica, Colombia INVIMA, Mexico COFEPRIS, Brazil ANVISA, Argentina ANMAT.

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).

PRACTICAL GUIDE | 2026

The most-asked question in offshore FIH — answered with the actual regulation.

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.

Will the FDA accept data from a Latin American first-in-human trial? It is the single most-asked question in our offshore FIH practice. Sponsors ask it in nearly identical words on almost every first call: “Do I have to present this data to the FDA?… what approval do I need before doing that?” A US medtech sponsor once told us he feared an IDE rejection of “South American” data outright. Our answer then and now: that is not an issue at all — provided the study is run to the standard FDA actually asks for.

First, the definitions. FIH means first-in-human: the first time a device or drug is tested in people. GCP means good clinical practice — the international quality standard for designing, conducting, recording, and reporting clinical investigations so the data are credible and subjects are protected (ICH E6; ISO 14155 for medical devices). An IDE is a US investigational device exemption, the FDA permission to study a significant-risk device in humans.

What does the FDA actually require for foreign clinical data?

The rule for medical devices is 21 CFR 812.28, “Acceptance of data from clinical investigations conducted outside the United States.” FDA will accept information on an outside-the-US investigation to support an IDE or a device marketing application — a PMA, a 510(k), or a De Novo request — if the investigation was well designed and well conducted and specific conditions are met. The headline condition is a statement that the investigation was conducted in accordance with GCP, defined as a standard for design, conduct, performance, monitoring, auditing, recording, analysis, and reporting that provides assurance the data and results are credible and accurate and that subjects’ rights, safety, and well-being are protected. GCP includes prior and continuing review and approval by an independent ethics committee (IEC) — what US sponsors call an IRB — and documented, freely given informed consent. The sponsor must ensure FDA is able to validate the data, including by on-site inspection if the agency deems it necessary, and must supply supporting information on the investigators, the protocol, and how GCP compliance was achieved.

For drugs and biologics, the parallel rule is 21 CFR 312.120: FDA accepts foreign clinical studies not conducted under a US IND when they meet GCP requirements. The principle is the same across product types.

Does the FDA prefer data from some countries over others?

No. Sponsors sometimes assume FDA quietly discounts data from smaller or less familiar markets — Panama, El Salvador, the Dominican Republic. In practice, FDA has no published preference list and no country-level bar. The review question is always site-level: was this a qualified site, run by a trained investigator under an independent ethics committee, with GCP documentation FDA can audit? FDA’s scrutiny of any foreign dataset is the same wherever it comes from — GCP compliance, verifiability, and applicability of the study population and clinical practice to the United States. Choose countries by speed, cost, recruitment, and investigator quality. Do not choose them for a supposed “data prestige” ranking that does not exist in the regulation.

Do I have to present this data to the FDA?

Not necessarily. Many Latin American FIH studies are run for internal decision-making: prove the concept works in humans, learn how the device behaves, fix the design or the protocol. If the data never enter a US submission, there is no obligation to present them to the FDA. Early FIH data de-risk the FDA path instead: sponsors arrive at a pre-submission meeting or an IDE with real human evidence rather than assumptions. As Julio tells sponsors, “99% of our clients, they use the data” — and he has never seen FDA reject data because of the country where it was generated. Never. Never, never.

How do LATAM/US data splits work in pivotal studies?

When a pivotal program will run partly in Latin America and partly in the United States, the split is negotiated with FDA — it is “not a black-and-white answer.” Sponsors commonly discuss allocations such as 70–30, 80–20, or 50–50 between regions, typically in a pre-submission (Q-sub) meeting before the pivotal protocol is finalized. FDA wants assurance that the data support the US intended-use population, which is why the conversation happens up front, with the full FIH and feasibility record on the table.

Split model	Typical shape	When sponsors use it
LATAM-heavy (70–30)	Most enrollment in Latin America; US cohort confirms generalizability	FIH and feasibility already completed in LATAM; device is stable
Balanced (50–50)	Roughly equal enrollment	Sponsor wants parallel recruitment and a single global dataset
US-heavy (80–20)	Most enrollment in the US; LATAM sites add speed and diversity	Sponsor plans a US-led IDE with regional acceleration

The point: the split is a negotiation with FDA, not a dictate. Bring the question early and bring the data.

How do you de-risk FDA acceptance before the study starts?

• Confirm the protocol, monitoring plan, and data management meet ISO 14155 (devices) and ICH-GCP from day one — not as a retrofit before submission.
• Qualify investigators and sites against FDA-inspectable standards: training records, delegation logs, device accountability, source documentation.
• Document independent ethics-committee review and informed consent per GCP as defined in 21 CFR 812.28(a)(1).
• Build the inspectable file from the first patient, not the last. Our companion post, “What FDA Reviewers Actually Open After a LATAM Device FIH: The ISO 14155 Inspectable File,” covers that file’s mechanics; this post covers the acceptance question it serves.
• Consider an FDA pre-submission to align on the FIH study’s role in the IDE, 510(k), De Novo, or PMA strategy — especially before locking a pivotal data split.

Frequently asked questions

Q: Can I use Latin American FIH data in an IDE submission?

A: Yes — 21 CFR 812.28 expressly provides for FDA acceptance of outside-the-US device investigations supporting an IDE, when the study was well designed, GCP-compliant, and the data are credible and verifiable.

Q: What if my LATAM study was not fully GCP-compliant?

A: FDA allows a waiver request under 21 CFR 812.28(c), or a statement explaining the reason for noncompliance plus steps taken to ensure the data are credible and subjects were protected. Treat that as a fallback, not a plan: design for GCP from day one.

Q: Does FDA inspect Latin American sites?

A: FDA may validate foreign data through on-site inspection if it deems it necessary — and the sponsor must ensure that is possible. Build the site file as if an inspection is coming: that is the practical premise of the acceptance rule.

Q: Will FDA accept data from Panama, El Salvador, Colombia, or Brazil specifically?

A: The regulation sets no country-specific bar. FDA has never, to our knowledge, rejected data because of the Latin American country where it was generated. Site qualification and GCP compliance decide.

Q: Is GCP-compliant LATAM data usable in Europe or other regions too?

A: ICH-GCP is the international standard, so a GCP-compliant package is generally usable across regulators — but each region has its own submission rules. Confirm the strategy with regulatory counsel for every target market.

Q: Will the FDA accept data from a Latin American first-in-human trial run at two sites in two countries?

A: Yes, under the same conditions — multi-site, multi-country data are routine. Keep the GCP standard identical across sites and document any country-level differences in ethics or import processes.

Will the FDA accept data from a Latin American first-in-human trial? The evidence says yes — routinely, for years — when sponsors hold the study to the standard FDA wrote into the regulation. Geography is not the risk. Sloppy GCP is.

Talk with bioaccess® about your Latin America FIH strategy

If you are weighing a Latin American first-in-human and want to know how the data would slot into your FDA strategy — IDE, 510(k), De Novo, or PMA — we will walk through it with you before you spend anything.

Talk with bioaccess® about your Latin America FIH strategy

References

• 21 CFR 812.28 — Acceptance of data from clinical investigations conducted outside the United States (medical devices).
• 21 CFR 312.120 — Foreign clinical studies not conducted under an IND (drugs and biologics).
• FDA guidance: “Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions” — https://WWW.FDA.GOV/media/111346/download
• bioaccess® operational experience with LATAM FIH studies and FDA submissions, 2021–2026. Last verified: September 2026.

PRACTICAL GUIDE | 2026

First-in-Human for Biopharma in Latin America: Phase 1, Healthy Volunteers, and Bioanalytical Lab Selection

For biopharma FIH, the study is only half the question. The other half is who runs the assays — and whether regulators will accept the data.

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.

Publishing package

Key entities, defined plainly. FIH means first-in-human — the first time a drug is given to people. Phase 1 is the first clinical stage, usually in healthy volunteers (HV). A bioanalytical lab measures drug concentrations (PK, pharmacokinetics), effects (PD, pharmacodynamics), immune responses (ADA, anti-drug antibodies), and biomarkers in study samples. GCP (Good Clinical Practice) governs clinical studies; GCLP (Good Clinical Laboratory Practice) applies GCP principles to labs that analyze clinical samples; GLP (Good Laboratory Practice) governs nonclinical studies. ICH M10 is the international guideline for bioanalytical method validation and study-sample analysis. LC-MS/MS (liquid chromatography–tandem mass spectrometry) and LBA (ligand-binding assay) are the two main analytical platforms. INVIMA is Colombia’s regulator, ANMAT is Argentina’s, and ANVISA is Brazil’s. B/BE means bioavailability/bioequivalence; ISO 17025 is a laboratory competence standard; SLA is a service-level agreement on turnaround time.

Why does bioanalytical lab selection start before first patient in?

In a device FIH, the data product is the clinical outcome. In a biopharma FIH, the data product is the assay result — PK curves, ADA incidence, biomarker movement. If the lab is wrong, the study is wrong, no matter how good the clinic is. Dose-escalation decisions run on bioanalytical turnaround: slow assays mean slow cohorts. Select the lab during synopsis development, not after the protocol is final.

What should a sponsor check when selecting a bioanalytical lab?

Six checks. Every one of them is verify-before-you-commit:

1. GCP/GCLP compliance — not “GLP accreditation.” The lab analyzes clinical samples, so require GCP/GCLP compliance. GLP governs nonclinical studies; a lab with GLP experience for nonclinical support is a plus, but “GLP-accredited” is the wrong standard for a clinical bioanalytical lab.
2. PK methods validated or transferred per ICH M10. Chromatographic (LC-MS/MS) or ligand-binding methods, as appropriate to the molecule. Method validation or a documented method transfer — not a handshake.
3. ADA and biomarker assays validated fit-for-purpose. Immunogenicity (ADA) and biomarker assays must be validated under fit-for-purpose approaches consistent with FDA and EMA immunogenicity guidance. Be explicit about this: ICH M10 does NOT cover immunogenicity or biomarker assays. A lab that answers “we follow M10” for an ADA assay has not answered the question.
4. Documented regulatory inspection history. Ask for inspection history and findings. There is no formal “prior data acceptance” register at INVIMA, ANVISA, or ANMAT — do not let anyone sell you a listing that does not exist. Prefer labs that sit inside a regulator-authorized Phase 1 center (for example, under ANMAT’s post-7516/2025 FIH-center authorization framework).
5. Turnaround SLA fast enough for dose escalation. Dose-escalation committees decide on data. Get the turnaround commitment in writing, and keep a central-lab fallback (US or EU) for any method not locally validated.
6. Lock the assay format, matrices, and biomarker panel early. In the synopsis — not during study startup. Late changes to the assay panel are one of the most common preventable causes of FIH delay.

Criterion	What good looks like	Red flag
Compliance standard	GCP/GCLP-compliant lab; GLP experience for nonclinical support a plus	“GLP-accredited” presented as the clinical-lab standard
PK validation	ICH M10-validated or transferred methods (LC-MS/MS or LBA)	No validation package; verbal assurance only
ADA / biomarkers	Fit-for-purpose validation per FDA/EMA immunogenicity guidance	“We follow ICH M10” for an ADA assay
Regulatory track record	Documented inspection history; lab inside a regulator-authorized Phase 1 center	Claims of a formal “accepted lab” register that does not exist
Turnaround	Written SLA supporting dose-escalation cadence; central-lab fallback	No SLA; no fallback plan
Assay lock	Format, matrices, and panel fixed in the synopsis	Assay decisions drifting into startup

Does INVIMA B/BE certification or ISO 17025 settle the question?

No — and this is a common expensive misunderstanding. INVIMA’s bioavailability/bioequivalence (B/BE) certification is a BE-only scheme built for generic-drug registration. For an FIH program, treat it as an optional quality signal about a lab’s general discipline — never as an FIH requirement. A lab without B/BE certification is not disqualified from FIH work, and a lab with it is not automatically qualified.

ISO 17025 works the same way: a genuine differentiator in laboratory competence, but not a requirement for FIH bioanalysis. Use it as a tiebreaker between two otherwise equal labs, not as a gate.

Where do healthy-volunteer Phase 1 units fit in Latin America?

Argentina and Chile make a strong primary/backup healthy-volunteer pairing: established Phase 1 unit infrastructure, experienced investigators, and — in Argentina — a defined Phase I review clock of 35 technical plus 10 administrative business days (about 45 total) under ANMAT Disposición 7516/2025, Annex III. Mexico and Brazil have deep clinical infrastructure, but their healthy-volunteer Phase 1 capacity is less established than Argentina’s and Chile’s — factor that into country selection for a healthy-volunteer study, not just the regulatory clock.

Frequently asked questions

Is GLP accreditation required for the bioanalytical lab?

No. GLP governs nonclinical studies. For a lab analyzing clinical FIH samples, require GCP/GCLP compliance. GLP experience supporting nonclinical work is a bonus, not the standard.

Does ICH M10 cover immunogenicity and biomarker assays?

No. ICH M10 covers chromatographic and ligand-binding PK assays. ADA and biomarker assays need fit-for-purpose validation consistent with FDA and EMA immunogenicity guidance.

Can I use my US or EU central lab instead of a local one?

Yes — keep a central-lab fallback for any method not locally validated. Build it into the plan and the budget from the start, not as an emergency fix.

Does an INVIMA B/BE certificate qualify a lab for FIH bioanalysis?

It is an optional quality signal only. B/BE certification is a generic-registration scheme, not an FIH requirement.

Is there an official list of regulator-accepted bioanalytical labs?

No. There is no formal prior-acceptance register at INVIMA, ANVISA, or ANMAT. Evaluate documented inspection history instead.

How fast can a Phase 1 start in Argentina?

ANMAT’s Phase I clock is 35 technical plus 10 administrative business days — about 45 total — under Disposición 7516/2025, Annex III.

That discipline — lock the assays early, select the lab on documented evidence, and pair your healthy-volunteer units across countries — is what First-in-Human for Biopharma in Latin America: Phase 1, Healthy Volunteers, and Bioanalytical Lab Selection is really about. The lab is part of the study design, not a procurement line item.

References

• ICH M10 — Bioanalytical Method Validation and Study Sample Analysis.
• FDA and EMA immunogenicity/ADA assay guidance (fit-for-purpose validation).
• ANMAT Disposición 7516/2025, Annex III (Phase I review clock: 35 technical + 10 administrative business days).
• OECD Principles of GLP and GCLP guidance documents (scope: nonclinical vs. clinical-sample analysis).

PRACTICAL GUIDE | 2026

The Two-Country FIH Strategy: De-risking Timelines and Enrollment with Parallel Programs

One country is a plan. Two countries are insurance.

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.

Publishing package

FIH is first-in-human: the first time a device or drug is tested in people. A two-country FIH strategy does not mean running the same study twice. It means designing one program with staged, sequential cohorts across two countries in Latin America — early cohorts enrolling in the faster-activating market while the second market completes startup, with each cohort's safety data reviewed before the next begins. The two-country FIH strategy is timeline insurance: if one country's startup stalls or enrollment underperforms, the program still moves.

This is a design framework, not a promise about any specific pair of countries. Every pairing below is illustrative — an example of how the selection logic works, not a guaranteed outcome. The right pair depends on your device, your indication, and the feasibility data.

How does a staged two-country program actually work?

The architecture is sequential cohorts, parallel infrastructure:

1. Country A activates first. Typically a fast-corridor market — Panama, El Salvador, Chile, or Costa Rica — where ethics and regulator submissions run in parallel and activation is measured in weeks. Early cohorts enroll here.
2. Country B starts up in parallel. A larger market — Brazil, Mexico, Colombia, or Argentina — with deeper investigator benches and larger patient populations, on its longer startup clock. Its sites come online as later cohorts begin.
3. Safety gates between cohorts. Each cohort's safety data is reviewed independently before the next cohort enrolls, regardless of which country hosts it. The safety review is per-cohort, not per-country.
4. Enrollment flexes to reality. If Country A enrolls faster than modeled, later cohorts can expand there. If it underperforms, Country B's sites absorb the load. The program is no longer hostage to a single site's patient flow.

Note what this is not: it is not two independent studies, and it is not a way to dodge safety oversight. One protocol, one safety standard, two (or more) national regulatory pathways executed in parallel.

How do you choose the country pair?

Pair selection is the whole game. The framework bioaccess® uses weighs six criteria — and the answer is almost never 'the two fastest countries':

Selection criterion	What to evaluate	Why it matters
Activation speed	Weeks-to-activation by pathway: fast corridor (weeks) vs. major markets (months).	Determines which country hosts the early cohorts.
Patient flow for your indication	Real site-level flow, not national population. Small countries can starve a program; large countries with the wrong referral patterns can too.	Enrollment is the risk you are insuring against.
Investigator depth	Number of qualified investigators and backup sites per country.	One brilliant investigator is a single point of failure.
Perceived data rigor	How regulators and future partners view data from each market. Brazil, Argentina, Mexico, Colombia, and Chile generally sit in the top tier.	Matters when the FIH data must support FDA or partner discussions.
Cost tier	Site and hospital fees vary widely — hospital fees in El Salvador, for example, run well below Panama's.	A fast country that breaks the budget is not fast.
Import and startup mechanics	Import-permit lead times, IOR requirements, translation burden.	Two countries means two import workstreams; plan both from day one.

What do illustrative pairings look like?

These are design examples showing how the criteria combine — not recommendations for your study and not guaranteed outcomes:

• Fast corridor + major market. Early cohorts in a fast-activating country (Panama, El Salvador) while a larger market (Brazil, Colombia) completes startup for later cohorts. Speed now, scale and data-rigor perception later.
• Fast corridor + backup. Primary enrollment in one fast country with a second fast country on standby — for example, Panama primary with El Salvador or Chile ready to activate. Lower startup cost than a major-market pairing; less enrollment depth.
• Major market + major market. For programs that need enrollment volume from day one and can fund two full startup tracks. Maximum enrollment insurance, maximum cost.

The pattern: one country buys speed, the other buys depth, redundancy, or perception. If both countries in your pair serve the same purpose, you have not designed a strategy — you have duplicated a budget.

What does the two-country FIH strategy cost — and what does it buy?

Honest accounting. A second country roughly duplicates the startup-phase costs: a second ethics and regulatory filing, a second import-permit workstream, additional site qualification, translation, and CRO startup fees. It does not duplicate the per-patient economics — you are still enrolling the same total cohort; you are buying a second place to enroll them.

What that buys: the two-country FIH strategy converts the two largest FIH schedule risks — a stalled approval and a dry enrollment pipeline — from program-killers into manageable variances. For a venture-backed sponsor whose runway is measured in months, that insurance is frequently cheaper than the delay it prevents. For a well-funded sponsor with a common indication and proven sites, it may be unnecessary. The feasibility data should make the call, not the ambition.

When should you NOT go multi-country?

• The indication enrolls easily and one country's feasibility numbers are strong — redundancy without risk is overhead.
• The budget cannot absorb two startup tracks without cutting corners on monitoring or data quality. Never fund the second country by thinning the first.
• The device or protocol is still changing. Multi-country startup multiplies the cost of every amendment.
• No feasibility work has been done in either country. Two unvalidated countries are not diversification; they are two guesses.

Design checklist: the two-country FIH strategy done right

1. Run feasibility in both countries before committing. Test two to three countries; let site-level patient flow and startup clocks — not enthusiasm — pick the pair.
2. Assign each country a job. Speed, depth, redundancy, perception: if a country has no defined role, cut it.
3. Stage the cohorts with safety gates. Sequential cohorts, independent safety review between them, regardless of which country hosts each cohort.
4. Run both startup tracks in parallel. A backup country that starts up after the primary fails is not a backup; it is a rescue mission.
5. Budget the full second startup. Two filings, two import workstreams, two site qualifications. Price it honestly or do not do it.
6. Keep one protocol and one data standard. ICH-GCP (International Council for Harmonisation Good Clinical Practice) data from qualified sites is what makes multi-country FIH data usable downstream — including for FDA discussions.

Frequently asked questions

Does a two-country FIH study mean double the patients?

No. The total cohort is the same; it is distributed across the two countries' sites. You are buying a second enrollment engine and a second regulatory pathway, not a second study.

Which country should enroll the first cohort?

Usually the faster-activating one, so first-patient-in is not hostage to the slower market's startup clock. The slower market's sites join for later cohorts once activated.

Will the FDA accept FIH data from two Latin American countries?

FDA acceptance turns on ICH-GCP compliance and qualified sites and investigators — not on the number of countries. Multi-country data generated to one protocol and one standard is routinely usable; see our post on FDA acceptance of LATAM FIH data.

How much more does the two-country FIH strategy cost?

Roughly a duplicated startup track: second ethics/regulatory filing, second import workstream, added site qualification and translation. Per-patient costs do not double. The honest comparison is against the cost of a multi-month delay.

Can we add the second country later if the first one stalls?

You can, but a country added in panic starts its clock at zero — months behind. The insurance value comes from running both startup tracks in parallel from the beginning.

Is a two-country strategy the same as a backup site?

No. A backup site is redundancy within one regulatory pathway. A second country is redundancy across regulatory pathways — it protects against approval delays and country-level enrollment failure, which no backup site can fix.

Design the program before you commit to the countries

The two-country FIH strategy is a program-design decision, not a reaction to a stalled startup. bioaccess® builds staged multi-country FIH programs across Latin America — feasibility in two to three markets, parallel startup tracks, sequential cohorts with independent safety review — so your timeline survives contact with reality.

Talk with bioaccess® about your Latin America FIH strategy

Regulatory references

• ICH E6 Good Clinical Practice (GCP) — the data standard underlying multi-country FIH programs.
• bioaccess® blog: Will the FDA Accept Data from a Latin American First-in-Human Trial? (2026).
• bioaccess® blog: How Long Does It Take to Start a First-in-Human Trial in Latin America? A Country-by-Country Startup Clock (2026).
• bioaccess® blog: El Salvador, Panama, Chile, Costa Rica: Inside Latin America's Fast-Track FIH Corridor (2026).
• bioaccess® blog: Patient Recruitment for FIH Trials in Latin America: What the Feasibility Numbers Actually Look Like (2026).

PRACTICAL GUIDE | 2026

The homework every investigator completes — even the preselected one.

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.

Suggested URL slug	qualify-fih-sites-investigators-latam
SEO title	How We Qualify FIH Sites and Investigators in Latin America | 2026 Guide
Meta description	Inside bioaccess®'s site qualification method: questionnaire, sponsor approval, outreach, on-site evaluation — and why even preselected investigators do the homework.
Suggested excerpt	What does a site-search line item actually buy? The four-step qualification method bioaccess® has run for twenty years — and the five elements every site must pass.

A sponsor once told us our site-search line item seemed very high. Fair question. Here is the answer, with nothing hidden: how we qualify FIH sites and investigators in Latin America, step by step. We have been doing this for twenty years — and the method is the same whether the investigator is new to us or preselected by the sponsor.

• bioaccess® — a first-in-human (FIH) contract research organization (CRO) running early-stage clinical trials across Latin America.
• FIH (first-in-human) — the first clinical use of a device or drug in people — typically a small, closely monitored early-feasibility study.
• Site qualification — the structured process of selecting and vetting a clinical site and investigator before a study starts — distinct from site initiation, which activates an already-selected site.
• CRO (contract research organization) — the company contracted to run the clinical trial on the sponsor's behalf.

What does the site-search line item actually include?

Four things: questionnaire build, sponsor approval, outreach, and evaluation. The questionnaire is built for your device and your protocol — not a generic form. You approve it before it goes out. Then we run outreach to candidate sites and evaluate the responses on site. That is the line item. It looks expensive until you price a wrong site: a site that cannot enroll, cannot execute, or cannot survive an inspection costs multiples of the qualification fee.

What are the four steps of qualification?

Step	What happens	Why it matters
1. Questionnaire build	A site-qualification questionnaire tailored to the device, the procedure, and the protocol.	Generic forms miss device-specific risks.
2. Sponsor approval	You review and approve the questionnaire before outreach begins.	No surprises about what we are screening for.
3. Outreach	Structured contact with candidate sites and investigators.	Breadth before depth — the shortlist earns its place.
4. On-site evaluation	In-person assessment of the site and the team.	Paper claims get verified where the work happens.

What do you assess at each site?

Five elements — the whole environment, not just the physician's CV:

• The investigator — clinical credibility, FIH-relevant experience, and genuine interest. Interest is a qualification criterion, not a pleasantry — it predicts enrollment.
• Patient flow — real, current, eligible-patient volume for this indication — the direct input to the enrollment model.
• Coordinators — the study coordinators who run the day-to-day: experience, bandwidth, and language capability.
• Equipment — the procedure requires specific equipment; its presence and condition are verified on site, not assumed from a brochure.
• Certified site — the site's certifications and inspection readiness, so the data file survives regulatory scrutiny.

What if we already chose our investigator?

Even a preselected investigator gets the homework. The questionnaire goes out, the evaluation happens, and the environment gets qualified. Preselection is a head start, not a waiver — some of our best-performing sites were preselected, and some preselected sites failed the evaluation. The process is the same either way, because how we qualify FIH sites and investigators in Latin America does not change with who made the introduction.

Does the investigator need experience with our exact device?

Exact prior-device experience is nice to have, not required. What is required: relevant procedural skill, research discipline, real patient access, and a team that can execute a first-in-human protocol. A great investigator learns a new device quickly; a weak environment cannot be fixed by device familiarity. We weight the five elements accordingly.

What should I ask any CRO about site qualification?

• Show me the questionnaire you would build for my device — is it tailored or generic?
• Who approves it, and when — before or after outreach?
• What specifically happens during the on-site evaluation?
• What are your go/no-go criteria?
• What happens when a preselected investigator fails the evaluation?
• How do you verify patient flow — self-reported numbers or chart-level evidence?

Frequently asked questions

Have you worked with these sites before?

We have been doing this for twenty years, so the answer is often yes — but every program re-qualifies. Past work is a head start, not a substitute for the current questionnaire and evaluation.

Why not skip qualification for a site we already know?

Because sites change: investigators move, coordinators turn over, equipment ages, patient flow shifts. The homework verifies the site as it is today, not as it was in the last program.

How long does site qualification take?

It runs in parallel with regulatory preparation; the timeline depends on the country, the number of candidate sites, and how quickly the sponsor approves the questionnaire. Ask us to map it against your startup clock.

What is the difference between site qualification and site initiation?

Qualification selects the site — it answers whether this site should run the study. Initiation activates an already-selected site: training, contracts, and green-lighting enrollment.

Do you qualify backup sites?

Yes. Backup sites are prequalified before first patient in, so adding enrollment capacity later is a decision, not a new project.

What fails a site most often?

In our experience, it is rarely the investigator's skill — it is patient flow that does not match the claims, or coordinator bandwidth that cannot absorb a first-in-human protocol's demands.

See the questionnaire we would build for your device

bioaccess® qualifies FIH sites and investigators across Latin America — questionnaire, sponsor approval, outreach, and on-site evaluation, with the whole environment assessed. Send us your protocol and we will show you what the homework looks like.

Talk with bioaccess® about your Latin America FIH strategyTalk with bioaccess® about your Latin America FIH strategy

References

• Methodology described reflects bioaccess® site-qualification practice and sponsor Q&A, 2021–2026 (all clients anonymized).
• Related reading: “How to Choose the Right CRO for First-in-Human Studies in Colombia” (bioaccessla.com blog).
• General: confirm site-selection strategy against the final protocol before contracting sites.

PRACTICAL GUIDE | 2026

No checklist. One standard: convince the committee the product will be safe in humans.

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.

How much preclinical data do you need before a first-in-human in Latin America? Sponsors usually arrive expecting a checklist — a fixed list of studies, species, and durations that unlocks the clinic. Latin American regulators do not work that way. There is no region-wide preclinical checklist and no codified rule that studies must be GLP-compliant as a condition of first-in-human authorization. There is one standard instead: prove the device or drug will be safe in humans. The burden of proof is on you.

Definitions first. Preclinical (nonclinical) data is the bench and animal testing done before a product enters humans — biocompatibility, toxicology, safety pharmacology, animal performance studies. GLP means good laboratory practice (21 CFR Part 58 in the US): the quality system for nonclinical lab studies. Non-GLP or “R&D-grade” data was generated without that formal quality system. The distinction matters less in Latin America than sponsors expect — and more, later, at FDA.

Is there a fixed preclinical checklist for a LATAM first-in-human?

No. No Latin American regulator publishes a 21 CFR Part 58-style list of required preclinical studies for first-in-human authorization. Colombia’s INVIMA publishes an inventory of approved and not-approved device studies — protocol, product, sponsor, site, investigator — but no required species, sample sizes, durations, or GLP stamp. Chile’s guidance requires preclinical testing and risk evaluation to be exhaustive and sufficient to support the investigation, under ISO 14971, while expressly disclaiming any device-specific test menu. The file that is actually read is a risk-management file plus an investigator’s brochure — not a checklist with boxes to tick.

Is non-GLP preclinical data enough?

For medical devices, yes — with rationale. “If you have the rationale to support why that drug doesn’t need that specific test, that should be sufficient.” R&D-grade data has supported real first-in-human device programs in the region: biocompatibility files, animal performance studies, and risk assessments accepted on the strength of their science rather than their quality-system stamp. A rationale can substitute for a specific test when it explains why the test is unnecessary — not merely that it was skipped.

For drugs and biologics, narrow the claim. Colombia’s medicines framework expects an ICH M3(R2)-type nonclinical safety package, and a non-GLP pivotal toxicology study for a new chemical entity or biologic will draw questions from INVIMA and the ethics committee in the same way it would from FDA. There is no Colombian rule that says “tox studies must be GLP” — but say “no explicit GLP mandate” rather than “non-GLP is accepted.” And note Brazil: ANVISA’s nonclinical guidance expects GLP-conducted safety studies for medicines — the closest thing to an explicit GLP expectation in the region, though it sits at guidance level and applies to drugs, not the device pathway.

Can we reuse the data we already generated abroad?

Yes — origin is not the criterion. Sponsors ask, “Can we just use everything we already used?” — testing done in China, non-GLP work from years ago. The answer: “They don’t care… GLP, non-GLP… regardless of where.” No LATAM regulator imposes a country-of-origin restriction on preclinical data. Three practical caveats make reuse succeed or fail:

• Language: reports must be submitted in Spanish, or with translation. Budget for it.
• Completeness: for novel products, reviewers expect full study reports — not summaries or slide decks.
• Traceability: show the standard used, the laboratory’s quality system (reviewers frequently ask about accreditation, such as ISO/IEC 17025 or a national GLP program, even where GLP is not mandated), and that the tested article matches the clinical product.

What does a convincing preclinical package look like?

Think of the package as an argument, not an inventory. Every study should answer a human-safety question, and the investigator’s brochure should tie the answers together:

• Map each test to a risk: what human harm does this study rule out, and for which patient population?
• Write the rationale for every test you did not run — the missing study with the best explanation beats the missing study with none.
• In Colombia, include the procedure risk matrix: regulators there want the risk analysis of the clinical procedure, not just the product. Confirm exactly what the committee expects before filing.
• Tie it to ISO 14971 risk management for devices: hazards, harms, controls, and residual risk, all traceable.
• Keep the test article consistent: the device or formulation tested preclinically must be the one going into humans, or the bridge must be explicit.

Does a LATAM-sufficient package satisfy the FDA later?

Not automatically — and this is the strategic point. FDA generally expects IND-enabling safety pharmacology and toxicology to follow GLP (21 CFR Part 58). A package that clears a Latin American first-in-human and a package that supports a US IND are not always the same thing. Design the preclinical program for both endpoints from the start: run the LATAM FIH on the rationale the region accepts, but build the tox package so it also serves the later FDA path. The cheapest preclinical program is the one you run once.

Frequently asked questions

Q: Is GLP required for a first-in-human trial in Colombia?

A: No codified GLP requirement exists for FIH authorization in Colombia — for devices, R&D-grade data with strong rationale has been accepted. For drugs and biologics, expect INVIMA and the ethics committee to probe non-GLP pivotal toxicology closely.

Q: Can we use preclinical data generated in China?

A: Yes. No LATAM regulator restricts preclinical data by country of origin. Submit full study reports in Spanish (or translated), with lab accreditation and test-article traceability documented.

Q: What if we skipped a standard preclinical test?

A: Provide the scientific rationale for why that test was unnecessary for your product. A reasoned omission is defensible; an unexplained gap is not.

Q: Who decides whether our preclinical package is sufficient?

A: The national regulator (e.g., INVIMA in Colombia) together with the ethics committee — which in Colombia does primary review. Their standard is sufficiency of evidence for human safety, not checklist compliance.

Q: How much preclinical data do you need before a first-in-human in Latin America — really?

A: Enough to convince a regulator and an ethics committee that the product will be safe in humans, documented so each study maps to a risk. That is the entire rule. Everything else is execution.

Q: Does non-GLP preclinical data hurt us with FDA later?

A: It can, for drugs: FDA generally expects IND-enabling safety studies under GLP. Plan the program so the LATAM FIH package and the future IND package are built together, not twice.

How much preclinical data do you need before a first-in-human in Latin America? As much as it takes to meet the burden of proof — no more, no less, and no checklist will tell you the number. Bring the rationale, not just the reports.

Talk with bioaccess® about your Latin America FIH strategy

Bring us your existing preclinical package — GLP, non-GLP, generated anywhere. We will assess it against the burden-of-proof standard for your target countries and tell you what is sufficient, what needs a rationale, and what needs to be run.

Talk with bioaccess® about your Latin America FIH strategy

References

• Colombia: Decreto 4725 de 2005 (medical-device regime, including investigational use of unregistered devices); Resolución 8430 de 1993 (ethical norms for health research); INVIMA device clinical-investigation guidance. Resolución 2378 de 2008 adopts GCP for medicines trials.
• Chile: ANDIM/ISP guidance — preclinical testing and risk evaluation must be exhaustive and sufficient under ISO 14971; no device-specific test menu.
• Brazil (medicines): ANVISA nonclinical guide expects GLP-conducted safety studies — guidance-level expectation; confirm current text before relying on it.
• US reference: 21 CFR Part 58 (GLP for nonclinical laboratory studies); ICH M3(R2) (nonclinical safety studies for human trials).
• bioaccess® preclinical sufficiency experience across LATAM FIH programs, 2021–2026. Last verified: September 2026.

PRACTICAL GUIDE | 2026

When the rebate math works, when it doesn’t, and what sponsors learn too late.

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.

Latin America vs. Australia for first-in-human trials is the comparison sponsors actually run. Australia is bioaccess®’s real FIH competitor — sponsors arrive already sold on offshore FIH and ask us to argue the other side. So here is the honest version: Australia’s genuine advantages, where it falls short, where Latin America wins, and when each region is the right call.

Definitions first. FIH means first-in-human — the first testing of a device or drug in people. Australia’s R&D Tax Incentive (RDTI) is a government tax offset for eligible research and development: a 43.5% refundable offset for companies with aggregated turnover under A$20 million, meaning the credit is paid in cash even to companies with no tax liability. TGA is Australia’s Therapeutic Goods Administration, the national regulator.

What does Australia offer FIH sponsors?

Australia’s headline advantage is real money. The RDTI provides a 43.5% refundable tax offset on eligible R&D expenditure for companies with aggregated turnover below A$20 million (larger companies receive a non-refundable offset starting at 38.5%, scaling with R&D intensity). For a cash-constrained startup, a cash refund on nearly half of eligible spend is a powerful funding mechanism. Clinical trials are a core use case: biotech companies routinely claim trial costs, and the program is jointly administered by AusIndustry and the Australian Taxation Office.

Beyond the rebate: English-language operations, mature TGA-regulated early-phase units, world-class hospitals in Sydney and Melbourne, and a global reputation for high-quality data that regulators everywhere recognize. Foreign companies can access the incentive, typically through an Australian subsidiary or local structure, provided the R&D is conducted in Australia — though eligibility turns on who incurs the expenditure and who owns the resulting IP, a frequent focus of audits.

Where does Australia fall short?

Cost before the rebate is high — early-phase unit fees, investigator costs, and operational overhead run well above Latin American levels, which is why the incentive exists at all. Recruitment is the deeper problem: Australia’s population is small and trial competition for patients is intense, so enrollment can drag. And approvals are not the smooth path sponsors expect — one US sponsor told us it lost three years in Australia because it could not get approval. That is one company’s experience, not a national statistic, but it is the kind of story that makes sponsors ask us for the comparison in the first place.

Where does Latin America win?

• Cost: typically 30–50%+ savings versus the US — lower per-patient and operational costs, with no rebate paperwork required to realize them.
• Speed: activation in as little as four weeks in the fast corridor (Panama, Chile, El Salvador, Costa Rica) versus the eight-month timelines sponsors report elsewhere.
• Recruitment: deep investigator access and large treatment-naïve populations; enrollment risk — the binding constraint in most FIH programs — is structurally lower.
• Time zones: US-aligned working hours, versus a 10–16 hour gap with Australia.
• Data acceptance: ICH-GCP data from qualified LATAM sites is routinely usable with FDA under 21 CFR 812.28 (devices) and 21 CFR 312.120 (drugs).

Dimension	Australia	Latin America
Net-cost lever	43.5% refundable R&D tax offset (eligible entities, turnover < A$20M)	30–50%+ lower base costs vs. the US; no claim process
Activation	Months; delays reported by sponsors	As little as 4 weeks in the fast corridor
Recruitment	Difficult; small population, high trial competition	Strong investigator access; large patient pools
Language	English	Spanish / Portuguese; bilingual CRO staff standard
Regulator	TGA	INVIMA, COFEPRIS, ANVISA, ANMAT, ISP, DIGEMID
US time-zone gap	10–16 hours	Aligned

When should you choose Australia over Latin America?

Honestly: when the rebate math genuinely works for you. If you already have — or will build — an Australian entity conducting eligible R&D, the 43.5% cash offset can beat LATAM’s base-cost advantage on paper. Australia also fits sponsors who specifically value TGA oversight, whose therapeutic area matches an Australian unit’s deep expertise, or whose investors simply prefer the jurisdiction. Run both models with real quotes before deciding — rebate-on-paper versus all-in cost are different numbers.

When should you choose Latin America?

When speed is the critical path. When recruitment risk — not budget — is what keeps you up at night. When you are a startup that needs the lowest absolute cash outlay, not a future tax refund. And when you want physician-level local execution in your time zone, with FDA-usable GCP data at the end of it.

Frequently asked questions

Q: Can a US company claim Australia’s R&D tax incentive for a clinical trial?

A: Yes, if the R&D is conducted in Australia — typically through an Australian subsidiary or local arrangement. Eligibility depends on who incurs the expenditure and effective ownership of the resulting IP, which auditors scrutinize.

Q: Is Australia cheaper than Latin America after the 43.5% rebate?

A: Sometimes on paper. The rebate applies to eligible expenditure; Australia’s pre-rebate costs are substantially higher, and the refund arrives after filing. Compare all-in, time-adjusted cost with real quotes — not headline rates.

Q: Will FDA accept FIH data from both Australia and Latin America?

A: Yes, under the same rules: GCP-compliant data from qualified sites. Geography is not the criterion in either case.

Q: Can we run FIH in both regions?

A: Yes — staged or parallel multi-region programs are common for de-risking timelines and enrollment. Each region’s data must meet the same GCP standard.

Q: How long do approvals take in Australia?

A: Timelines vary by study and pathway; sponsors have reported significant delays, including multi-year cases. Verify current expectations with a local regulatory advisor for your specific program.

Q: Latin America vs. Australia for first-in-human trials — what is the simplest decision rule?

A: If your binding constraint is absolute cash and speed to data, Latin America usually wins. If you have an Australian structure and the rebate math closes the gap, Australia deserves a real quote. Never decide on reputation alone — decide on quotes, clocks, and enrollment risk.

Latin America vs. Australia for first-in-human trials is not a contest with one winner. It is a trade: a world-class rebate compensating for world-class costs and recruitment friction, against lower base costs, faster activation, and deeper enrollment access. Know which constraint binds your program — and choose accordingly.

Talk with bioaccess® about your Latin America FIH strategy

Considering Australia, Latin America, or both? Send us your synopsis and we will model the two paths side by side — real startup clocks, real enrollment assumptions, real budget anatomy — so you decide on numbers, not narratives.

Talk with bioaccess® about your Latin America FIH strategy

References

• WilmerHale Launch (April 2026): Australia’s R&D Tax Incentive — 43.5% refundable offset for eligible entities with aggregated turnover below A$20 million — https://launch.wilmerhale.com/research/blog/20260413-dont-let-australias-r-d-tax-incentive-trigger-unintended-us-international-tax-cost-sharing-issues
• Opportuna Legal: Australia’s R&D Tax Incentive — general overview for clinical trials — https://www.opportunalegal.com.au/single-post/australia-s-r-d-tax-incentive-a-general-overview-for-clinical-trials
• bioaccess® client experience with Australia benchmarking and LATAM FIH programs, 2021–2026. Last verified: September 2026.