Figures cited from named public press (Trendlines / Seger and PharmaDeviceNews, retrieved 1 September 2026) and the published bioaccess® El Salvador country page. Press mention_n is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current DNM/SRS, CNEIS, and FDA rules with qualified advisers. We name only the facility, PI, and sponsor those sources support. We do not invent a CRO the wires did not name. We do not claim Zacamil National Hospital or Seger Surgical Solutions as a bioaccess® client.
If you searched Zacamil National Hospital first-in-human, Zacamil Hospital CRO, SEGER IDEA El Salvador, or “go direct Zacamil San Salvador,” you followed a hospital name that is genuinely in the public file. Zacamil National Hospital / Zacamil Hospital in San Salvador is a real public hospital. It is not a first-in-human medical-device CRO, and it is not the operator of the DNM/SRS file.
bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns DNM/SRS, CNEIS 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 San Salvador is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A press release that names the building does not become a CRO.
This page is the intercept for the Zacamil press cluster. It is distinct from Clínica Quesada / Quesada Clinic (already intercepted: Clínica Quesada San Salvador FIH — Horizon Polaris robotic cataract). Different building. Different device class. Linking is correct. Cloning Quesada is not. Hospital El Salvador, named on the country hub as landscape infrastructure, is also not this hospital and not a facility we operate.
Why the hospital name wins the search — and why that is not a CRO
Device press writes the implant, the city, the hospital, and sometimes the surgeon. It rarely writes the CRO. On the 1 September 2026 LATAM device FIH/EFS press sweep, Zacamil National Hospital / Zacamil Hospital, San Salvador, El Salvador, is rank 8, mention_n=3. Example URLs the ranking actually used:
- The Trendlines Group, 17 March 2026 — Seger Surgical Solutions announced successful completion of three first-in-human cases of the SEGER IDEA™ laparoscopic bowel closure device. Procedures conducted at Zacamil National Hospital in El Salvador. Quote in that item: Dr. Francisco Alabi, Zacamil National Hospital, El Salvador. No CRO named.
- Matching OTC / Trendlines syndication of the same company milestone (same building, same n=3).
- PharmaDeviceNews, 16 March 2026 — names Zacamil Hospital; three first-in-human procedures; bowel-closure times under two minutes as reported in that article. That rewrite does not always name the PI. We will not invent a PI on that URL. We name Alabi only where Trendlines already printed it.
That is useful public information about a press-named San Salvador FIH site. It is how a founder googles “SEGER El Salvador” or “Zacamil first-in-human” and lands on a public hospital without landing on SRS, CNEIS, importer of record, ISO 14155, or 21 CFR 812.28. We cite those URLs as facility evidence. We will not invent a CRO. We will not claim bioaccess® ran the Seger FIH. No live bioaccess® case-study page names this hospital as a client site.
A later ClinicalTrials.gov row (NCT07508592) exists for a Seger feasibility study listing Hospital Nacional Zacamil. This intercept is the press page. We will not pad mention_n with NCT counts. If you came from the registry, read the NCT as a location string, not as a CRO product.
The site is the site. The CRO is the operator.
A San Salvador national hospital can provide rooms, surgical staff, and an investigator the sponsor already put in the wire. 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 surgical service.
- Share local research rules and how the case would physically run.
- 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:
- DNM / SRS. Superintendencia de Regulación Sanitaria (SRS) replaced Dirección Nacional de Medicamentos (DNM) in August 2024. The published El Salvador hub puts study startup at 30–60 days via parallel SRS and CNEIS review on one digital platform. A hallway conversation at Zacamil is not that file.
- CNEIS. Comité Nacional de Ética de la Investigación en Salud. Centralized ethics. Spanish protocol package.
- Investigational import. See importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent a Zacamil-only premium here.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
- The 21 CFR 812.28 package. Eligibility is not clearance. A site MSA does not produce it.
- Multi-country optionality. If San Salvador enrollment or the indication later needs Colombia, Panama, or another bioaccess® market, a single-hospital MSA will not stretch.
Going direct to Zacamil is how you confirm a room. It is not how you open an investigational file.
Site versus CRO
| Workstream | What Zacamil (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Rooms, surgical service, local staff, source documents | Protocol fit, training, device accountability |
| Ethics | Local cooperation with the national ethics process | CNEIS packet, ICF, IB alignment |
| National authority | Not the permit holder by appearing in a Trendlines item | DNM/SRS (30–60 day startup already published on the country hub) |
| Import | Receiving and storage if contracted | Importer of record |
| Quality | Hospital 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 San Salvador campus | Colombia (INVIMA) and the rest of the bioaccess® platform |
How DNM/SRS and CNEIS actually work (the short version)
Use clinical-trials-el-salvador for the full pathway. Facts a sponsor searching this hospital needs on one screen, already published there and not re-averaged here:
- SRS is the national regulatory authority (successor to DNM, August 2024). llms.txt still lists DNM; the live hub names both.
- Ethics is centralized at CNEIS. Parallel SRS + CNEIS on one digital platform is why the hub already publishes 30–60 day study startup.
- ~60% cost savings vs equivalent US programs, 98.5% GCP compliance across the published site network, and a US-dollar economy — already on that hub. We will not invent a Zacamil-only rate.
- This site does not publish DNM or SRS as PAHO/WHO Level 4. We will not invent that badge.
- Under 21 CFR 812.28, foreign clinical data from El Salvador is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper SRS authorization and CNEIS ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.
Ask for a protocol-specific calendar. A hospital email is not an SRS approval. bioaccess® manages the file. That is CRO work, not site work.
All bioaccess® El Salvador device protocols 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.
Do not smear the hospital — and do not merge Zacamil with Quesada
Zacamil National Hospital is a serious public resource. Three independent press URLs naming the building is a signal of public visibility, not a punchline. Use the site when the protocol fits. Hire the operator.
Do not merge this hospital into Clínica Quesada. Do not treat Hospital El Salvador (country-hub landscape name) as Zacamil. Different buildings. Different queries.
What the CRO still does after you have a Zacamil slide
- Regulatory-fit, not tourism. El Salvador is a lead first-in-human jurisdiction on the published hub. One San Salvador 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 SRS / CNEIS packet.
- Importer of record and device accountability.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate Zacamil only if it fits the protocol.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative — eligibility, not a promise of FDA action.
The firm was founded in 2010. That is the operator layer around a press-named hospital.
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 Zacamil National Hospital directly for a device FIH?
You can try. The hospital can discuss investigator interest and local procedure costs. It cannot, by appearing in three Seger URLs, become your SRS 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 SEGER IDEA first-in-human cases?
No public bioaccess® case-study page names this hospital. We will not invent that claim. mention_n=3 is a press-URL count, not bioaccess® enrollment.
Is this the same site as Clínica Quesada?
No. Quesada is a different San Salvador building already intercepted for a different public device story. This page is Zacamil only.
If I already have Zacamil, what does the CRO still do?
Regulatory-fit (El Salvador vs Colombia vs a multi-country design); the SRS/CNEIS packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one San Salvador room is not enough.
Next step
If the search that brought you here was Zacamil National Hospital or SEGER IDEA El Salvador, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in El Salvador. Distinct San Salvador clinic: Clínica Quesada.
Julio G. Martinez-Clark, CEO · bioaccess®