Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current INS, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim INEN Lima as a bioaccess® client.
If you searched INEN Lima first-in-human, Instituto Nacional de Enfermedades Neoplasicas clinical trial, INEN CRO Peru, or “go direct INEN Lima,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Enfermedades Neoplasicas (INEN) in Lima, Peru, is a real national cancer-institute string on ClinicalTrials.gov. The ranking dump stores it without an accent: Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru. bioaccess® does not operate INEN. It is not a first-in-human medical-device CRO, and it is not the operator of the INS file.
bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns INS / DIGEMID, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.
This page is the Lima INEN intercept. It is not a Brazil, Mexico, or Argentina campus. It does not clone ICESP or Barretos. Sharing an oncology search query is not a license to merge countries. We do not invent a Peruvian legal entity on this page.
Why the campus name wins the search — and why that is not a CRO
Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:
- Instituto Nacional de Enfermedades Neoplasicas (Lima, Peru): ALL interventional n=51 (rank 23). Example NCT IDs: NCT00002850, NCT00005970, NCT00022516.
Cite ALL only as given. We will not invent a DEVICE n.
Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.
We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.
That is the leak: a founder searching “INEN Lima clinical trial” finds rank 23 on ALL (n=51) without finding INS, DIGEMID, import, insurance, or 21 CFR 812.28. A national cancer-institute ranking is registry volume, not a CRO, and not a Peruvian entity we invent.
The site is the site. The CRO is the operator.
A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.
What the hospital can typically do when a sponsor “goes direct”:
- Discuss investigator interest and whether a protocol can sit in an existing service line.
- Share institutional ethics-committee calendars and hospital research rules.
- Quote visit, staffing, and local procedure costs for the cases they will physically run.
What the hospital is not built to own for an investigational device:
- INS. INS (DIIS, formerly OGITT) authorizes trials in Peru. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. A hallway conversation in Lima is not that stack. We will not invent DIGESA onto this page.
- Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent a campus-only premium here.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
- The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
- Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.
Going direct to this campus is how you confirm a room. It is not how you open an investigational file.
Site versus CRO
| Workstream | What INEN (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Rooms, caseload, local staff, source documents | Protocol fit, training, device accountability |
| Ethics | Institutional committee calendar and local rules | Packet, ICF, IB alignment, deficiency cycle |
| National authority | Not the permit holder by appearing on an NCT | INS / DIGEMID clinical-investigation file |
| Import | Receiving and storage if contracted | Importer of record |
| Quality | Hospital or university quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative — eligibility, not clearance |
| Country optionality | One Lima national cancer-institute NCT string | Colombia (INVIMA) and the rest of the bioaccess® platform |
How INS / DIGEMID actually works (the short version)
Use clinical-trials-peru. INS (DIIS, formerly OGITT) authorizes trials. A published statutory target on that hub is 40 business days in the drug-trial framework, and 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. We will not invent a new Peruvian clock on this page. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. The Peru hub already cites experience-based cost on the order of ~30% lower versus US/EU — that is a country-page figure, not an INEN quote we invent here.
bioaccess® does not claim to operate INEN and does not invent a Peruvian legal entity on this page. The hospital remains the site. The CRO still owns the file.
All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.
Ask for a protocol-specific calendar. A hospital email is not INS authorization or a DIGEMID import permit. bioaccess® manages the file. That is CRO work, not site work.
Do not smear the hospital
INEN is a serious Lima national institute. n=51 ALL is registry volume, not a punchline. This page is not a claim that bioaccess® operates INEN or that we have a Peruvian legal entity invented for the intercept. Use the site if the protocol fits. Hire the operator. Keep ICESP and Barretos on their Brazil pages.
What the CRO still does after you have the campus on a slide
- Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the INS / ethics packet.
- Importer of record and device accountability.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.
The firm was founded in 2010. That is the operator layer around a campus string.
Colombia is still on the map
A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I contract INEN Lima directly for a device FIH?
You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your INS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.
Did bioaccess® run the NCT IDs listed here?
No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.
Is this the same page as ICESP or Barretos Cancer Hospital?
No. Those are Brazilian NCT strings under ANVISA. This page is Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru, under INS / DIGEMID only.
If I already have this campus, what does the CRO still do?
Regulatory-fit (this country versus Colombia versus a multi-site design); the INS / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.
Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?
No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.
Is DIGEMID the only agency?
No. Name both. INS (DIIS, formerly OGITT) authorizes trials. DIGEMID under MINSA regulates devices and investigational import. Do not collapse the stack into “just DIGEMID.” We will not invent DIGESA.
Is the 40-business-day figure a device-FIH guarantee?
No. It is a published statutory target on the Peru hub in the drug-trial framework; 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. We will not invent a new clock. Ask for a protocol-specific calendar.
Does bioaccess® operate INEN or have a Peruvian entity named here?
No. We do not claim to operate INEN and do not invent a Peruvian legal entity. The hospital is the site. The ~30% lower versus US/EU figure is already on the Peru hub — not an INEN quote.
Next step
If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Peru.
Julio G. Martinez-Clark, CEO · bioaccess®