If you search CRO in Peru or CRO en Perú, you should land on the First-in-Human CRO that already runs the INS / DIGEMID file — not a brochure that invents a new clinical-trial clock.
bioaccess® is that CRO. Headquarters in Miami. We run clinical trials in Peru. INS and DIGEMID clocks already published on the hub are a file problem, not a reason to leave the country.
I am Julio Martinez-Clark, CEO of bioaccess®. This is the operator page for the query. Colombia is a second country category, with a local Colombian entity, and we still run trials there. Peru is not a replacement for Colombia. It is a country we already work.
What “CRO in Peru” has to mean
A Peru CRO for first-in-human devices is not a Latin America slide and a courier account. It is a company that can file in Spanish, sit an accredited ethics committee, keep the INS authorization moving, obtain the DIGEMID investigational-import authorization, and stay in the room after first patient in.
That is why this page does not invent a Peruvian legal entity. We have not published one. Miami HQ plus in-country operations on the INS file is the line that is already live on the Peru hub.
- Miami headquarters — sponsor desk on US Eastern time. Peru is close to that clock.
- INS (Instituto Nacional de Salud) through DIIS (Dirección de Investigación e Innovación en Salud, formerly OGITT) — already named on the hub.
- DIGEMID (Dirección General de Medicamentos, Insumos y Drogas) under MINSA — devices and investigational import, already on the hub.
- 40-business-day INS statutory target; 60 business days for biologics or technical-commission cases — already on the hub.
- Those targets derive from the drug-trial framework. Novel first-in-human device studies may take longer. That caveat is already on the hub. I will not invent a new Peru clinical-trial clock.
- ~30% lower (experience-based estimate) versus typical US/EU programs — already on the hub; experience since 2010, not a formal study.
Global Phase 1 networks can list Peru. They rarely hold the INS file. Local monitors can staff a visit. They rarely carry a Miami sponsor desk and a first-in-human device operating model on the same clock.
We run trials in Peru
The old hub hero sold a “strong option” and a predictable pathway. That is not the category. The category is: who is the CRO in Peru, and are they actually running studies.
We are. We still will. If you are choosing a CRO en Perú in 2026, ask whether the firm owns the INS docket now — not whether someone will invent a shorter clock for a slide.
INS review can move, stall, or come back with questions. First-in-human programs need a start date someone owns. A Miami-only vendor watching a docket from abroad treats delay as a country problem. The CRO that already works INS treats delay as responses, ethics alignment, DIGEMID import, and site activation on one timeline.
That is Global Trial Accelerators™ in practice: one accountable operating model across INS, ethics, DIGEMID, sites, insurance, importation, monitoring, and safety.
INS clinical trial: use the clock already on the hub
INS is Peru’s National Institute of Health. DIIS — formerly OGITT — is the directorate that reviews clinical-trial submissions. Those names are already public on the hub. I am not adding a new directorate, a new day-count, or a sponsor-specific INS matter. This is a category page. It cites the public hub.
The live hub already publishes:
- A 40-business-day statutory target for INS (DIIS) authorization.
- A 60-business-day target for biologics or cases that require technical-commission review.
- The statement that those targets derive from the drug-trial framework, and that novel first-in-human device studies may take longer.
Those are the public numbers. I will not invent a new median. I will not flatten the drug-trial target into a device-FIH guarantee. Ask for a study-specific calendar. The country stays on the execution list.
What the file actually contains, already described on the hub: a complete INS dossier, accredited ethics-committee approval, and — for the investigational article — the DIGEMID import authorization required to ship product into Peru. All of it in Spanish. bioaccess® prepares that package. We do not invent a Peruvian legal entity to do it.
DIGEMID is a second file — keep it off a made-up trial clock
Clinical-trial authorization and medical-device regulation are different files. The live hub already names DIGEMID, under the Ministry of Health (MINSA), as Peru’s medical device regulator and as the office that issues the investigational device import authorization. A commercial registration does not replace an INS clinical-trial authorization. An import permit does not replace ethics approval.
If you later want to sell in Peru, say so at kickoff so the trial importer and any later holder role are not improvised after first implant. This article does not quote LATAM Launch subscription pricing. That SKU lives on the market-access pages, not on a first-in-human hub. llms-full.txt already lists a DIGEMID 4–6 month band in the countries-and-agencies table; that is a registration-side figure, not a new trial clock, and I am not moving it onto the FIH hub.
Sites — no named hospital we operate
We contract sites. We do not operate a named Peruvian hospital. A city is not a site contract. A university hospital mentioned in a landscape piece is not a bioaccess® facility. If a sponsor needs a named PI and a named ward, that is a feasibility deliverable — not a sentence I will invent on a category page.
Accredited ethics-committee review is required before enrollment. Ethics review follows ISO 14155 and the Declaration of Helsinki. That is already on the hub. I am not adding a new disease map or a new site count.
FDA use of Peruvian first-in-human data
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets good clinical practice as that rule defines it, including ethics-committee review and informed consent. bioaccess® designs Peru studies with that FDA conversation in mind — electronic data capture, structured safety reporting, source data verification — under ISO 14155, with proper INS authorization and accredited ethics approval.
Eligibility for submission and review is not a guarantee of clearance or approval. ISO 14155 is the device GCP standard we align the file to. It is not a stamp the FDA owes you.
Cost — use the number already on the hub
The Peru hub already publishes ~30% lower (experience-based estimate) versus typical US/EU programs. I am not inventing a new band here. Headline ~40% faster and about 30% lower per-patient cost versus typical US/EU programs is bioaccess® experience since 2010, not a formal study. Time zone close to the US East Coast is already on the hub. Those are operating facts, not a tourism pitch.
Questions a sponsor should ask any CRO in Peru
- Are you running clinical trials in Peru now — not “historically”?
- Who owns the INS clock when the file sits?
- Do you repeat the hub’s 40- / 60-business-day statutory targets, including the drug-trial and FIH-device caveat — or are you inventing a shorter clock?
- Can you file the INS dossier in Spanish and sit the deficiency cycle?
- Is DIGEMID import a second file, or are you mixing it into the trial quote?
- Do you claim to operate a named hospital, or do you contract sites?
- Will the study file be built for 21 CFR 812.28, and do you understand that eligibility is not clearance?
bioaccess® answers: trials running; Miami HQ and in-country operations; INS / DIGEMID file owned as a file problem; 40- and 60-business-day targets kept as already published, with the FIH-device caveat; no new clock; no named hospital we operate; DIGEMID kept as a separate device / import file; FDA conversation designed in from day one.
How Peru sits next to Colombia
Do not read this as “leave Colombia.” We still run clinical trials in Colombia. That country has a local Colombian entity and its own hub. Peru is a country we already work. INVIMA stays INVIMA. INS stays INS. If a protocol fits both, say so and we will tell you which file opens first. We will not flip one country into the other.
See clinical trials in Colombia and clinical trials in Peru.
How to start
If you need a CRO in Peru / CRO en Perú for a first-in-human or early-feasibility device study — or you also need the separate DIGEMID device or import file — contact bioaccess® through bioaccessla.com/contact.
Bring the protocol stage, device class, and whether you also need a Peruvian market-access file. We will tell you how the INS clock already published on the hub would run for your study. We will not tell you to leave the country. We will not invent a legal entity, a hospital name, a sponsor-specific INS story, or a day-count we have not already published.
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