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 Hospital Nacional Cayetano Heredia as a bioaccess® client.
If you searched Hospital Nacional Cayetano Heredia first-in-human, Cayetano Heredia Lima clinical trial, HNCH CRO Peru, or “go direct Hospital Nacional Cayetano Heredia,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Nacional Cayetano Heredia in Lima, Peru, is a real named national-hospital string on ClinicalTrials.gov. It is not Universidad Peruana Cayetano Heredia. 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 named Lima hospital. Distinct from INEN Lima (CMS 95644). It is also not Universidad Peruana Cayetano Heredia (university string ALL n=23 — not this hospital). Sharing “Cayetano Heredia” is not a merge. 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:
Counts come from leftover rows in /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- Hospital Nacional Cayetano Heredia (Lima, Peru) — leftover ranking row: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT00352716, NCT00441285, NCT00612898.
- JSONL confirm on the same named hospital string (1 September 2026 dump): unique NCT IDs n=34. Cite leftover ALL n=25 as the ranking row. Cite JSONL n=34 as the same named hospital string confirmed. Do not treat 25 and 34 as two campuses.
- Do not merge Universidad Peruana Cayetano Heredia (ALL n=23). That is a university string, not this hospital page. Listed separately so a founder searching the university still does not land here as a union.
Cite leftover ALL n=25 as ranking. Cite JSONL n=34 as the named hospital string. Do not add them. Do not add the university n=23. DEVICE n=0; we will not pad it.
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 “Hospital Nacional Cayetano Heredia clinical trial” or “Cayetano Heredia Lima FIH” finds leftover ALL n=25 (JSONL named-string n=34) without finding INS, DIGEMID, import, insurance, or 21 CFR 812.28 — and without landing on INEN. A named Lima hospital is still a site. An NCT location row is not a CRO. We do not invent a Peruvian legal entity.
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. We do not invent a Peruvian legal entity. A hallway conversation at Hospital Nacional Cayetano Heredia is not an INEN file and is not a university-string file.
- 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.
How INS 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 a campus quote we invent here. We do not invent a Peruvian legal entity on this page.
Ask for a protocol-specific calendar. A hospital email is not INS clearance. bioaccess® manages the file. That is CRO work, not site work.
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.
Do not smear the hospital
Hospital Nacional Cayetano Heredia is a serious named Lima hospital on the public registry. Leftover ALL n=25 is registry volume, not a punchline. JSONL n=34 is the same named hospital string, not a second campus. Do not merge it into INEN or into Universidad Peruana Cayetano Heredia. Do not invent a DEVICE n. Do not invent a Peruvian legal entity. Do not invent a PI. Use the site when the protocol fits. Hire the operator.
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 Hospital Nacional Cayetano Heredia 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.
Is this the same page as INEN Lima or Universidad Peruana Cayetano Heredia?
No. INEN is CMS 95644. Universidad Peruana Cayetano Heredia is a university NCT string (ALL n=23), not this hospital. This page is Hospital Nacional Cayetano Heredia only. Leftover ALL n=25 is ranking; JSONL n=34 is the same named hospital string. We do not union with the university.
Should I add leftover ALL n=25 and JSONL n=34?
No. Leftover ALL n=25 is the ranking row. JSONL n=34 is the same named hospital string confirmed. They are not two campuses.
Is Universidad Peruana Cayetano Heredia this hospital?
No. That is a university string (ALL n=23). This page is the hospital. We do not merge them. INEN is CMS 95644, a different Lima string.
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. Ask for a protocol-specific calendar.
Did bioaccess® run NCT00352716?
No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.
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®