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 Barranco CRS Lima as a bioaccess® client.
If you searched Barranco CRS first-in-human, Barranco CRS Lima clinical trial, Barranco CRO Peru, or “go direct Barranco CRS Lima,” you followed a campus string ClinicalTrials.gov still publishes. Barranco CRS in Lima, Peru, is a real named research-site string on ClinicalTrials.gov. 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Lima Barranco CRS campus. It is not Hospital Nacional Guillermo Almenara Irigoyen (CMS 95763), not Hospital María Auxiliadora (CMS 95765), not INEN (CMS 95644), and not Hospital Nacional Cayetano Heredia (CMS 95697). Sharing Lima is not a license to collapse them.
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 unique strings after batch 16 (CMS 95766–95773 live) 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 We do not publish a unique-study union across alias strings.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. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- Barranco CRS (Lima, Peru) — canonical NCT string: ALL interventional n=16; DEVICE n=0. Example NCT IDs: NCT02583048, NCT02720094, NCT05534984.
Cite canonical ALL n=16 and DEVICE n=0. We will not invent a DEVICE ranking.
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 center as a client site.
That is the leak: a founder searching “Barranco CRS first-in-human” finds ALL n=16 (DEVICE n=0) without finding INS, DIGEMID, ethics, import, insurance, or 21 CFR 812.28. A named Lima research site is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named center 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 center 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 center 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 Barranco CRS is not an Almenara file and is not an INEN 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 center
Barranco CRS is a serious named Lima research site on the public registry. ALL n=16 is registry volume, not a punchline. Do not invent a DEVICE n. Do not invent a PI. Do not invent a Peruvian legal entity. 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 Barranco CRS Lima directly for a device FIH?
You can try. The center 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 center. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as Almenara, María Auxiliadora, INEN, or Cayetano Heredia?
No. Almenara is CMS 95763. María Auxiliadora is CMS 95765. INEN is CMS 95644. Cayetano Heredia is CMS 95697. This page is Barranco CRS, Lima only.
Did bioaccess® run NCT02583048?
No. We cite it as facility evidence. We will not invent a sponsor or a PI.
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. Lima siblings (do not merge): Almenara, INEN. Country: clinical trials in Peru.
Julio G. Martinez-Clark, CEO · bioaccess®