How We Qualify FIH Sites and Investigators in Latin America

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.