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 ARCSA, 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 IECED Guayaquil as a bioaccess® client.
If you searched IECED Guayaquil first-in-human, Instituto Ecuatoriano de Enfermedades Digestivas clinical trial, IECED Ecuador CRO, or “go direct IECED Guayaquil,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Ecuatoriano de Enfermedades Digestivas (IECED) in Guayaquil, Ecuador, is a real named institute-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ARCSA file.
bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ARCSA, CEISH 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 institute still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Guayaquil IECED campus. It is DISTINCT from English-alias ecuadorian-institute-digestive-diseases-guayaquil-fih and academy-tertiary-ieced-guayaquil-fih clone strings — do not publish those as separate ranks. Sharing Guayaquil / IECED is not a license to multiply pages. IECED is not a Quito National Police UDV string. IECED is not a generic Ecuador fold.
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 the last live leftover-site batch 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 We do not publish a unique-study union across alias strings.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.
- Instituto Ecuatoriano de Enfermedades Digestivas (IECED) (Guayaquil, Ecuador) — canonical NCT string: ALL interventional n=8; DEVICE n=4. Example NCT IDs: NCT05640401, NCT06102980, NCT06264466.
Cite canonical ALL n=8 and DEVICE n=4. Do not clone English IECED alias ranks or academy-tertiary-ieced onto this slug. Spell ARCSA on first use in agency copy via leftover_lib (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria).
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 institute as a client site.
That is the leak: a founder searching IECED Guayaquil first-in-human finds ALL n=8 (DEVICE n=4) without finding ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria). A named institute campus is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named institute 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 institute 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 institute is not built to own for an investigational device:
- ARCSA. ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria) is the national file for an investigational device study in Ecuador. CEISH ethics still has to sit before enrollment. A hallway conversation on this campus is not that stack. Live Ecuador blogs already use 4–8 week ethics and 30–90 day submission language; we will not invent a new median here. We do not invent an Ecuadorian legal entity. A hallway conversation at IECED Guayaquil is not an ARCSA / CEISH clearance and is not an English-alias IECED clone 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 ARCSA actually works (the short version)
Use clinical-trials-ecuador. ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria) — a decentralized Ministry of Health agency — authorizes clinical trials and classifies devices (I, IIa, IIb, III). Every study also needs written approval from a Human Research Ethics Committee (CEISH — Comité de Ética de Investigación en Seres Humanos) before enrollment. That hub does not invent a new Ecuador day-count; live Ecuador blogs already use 4–8 week ethics language and 30–90 day submission language under Ministerial Agreement 0075-2017 and later reforms. Ask for a protocol-specific calendar. Commercial sanitary / device classification is a second file. We will not invent PAHO/WHO Level 4 standing for ARCSA. We do not invent an Ecuadorian legal entity on this page. Headline ~30% lower (experience-based) program cost versus typical US/EU baselines is already on that hub — not a campus quote we invent here.
Ask for a protocol-specific calendar. A hospital email is not ARCSA 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
IECED Guayaquil is a serious named Ecuadorian campus on the public registry. ALL n=8 and DEVICE n=4 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator. We do not invent an Ecuadorian legal entity on this page.
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 ARCSA / 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
Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 IECED Guayaquil directly for a device FIH?
You can try. The institute can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ARCSA 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 institute. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as Ecuadorian Institute of Digestive Diseases (English alias) or academy tertiary IECED?
No. Those are alias / department_lab clone strings for the same Guayaquil IECED campus. This page is Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Guayaquil only — do not publish the English alias or academy-tertiary ranks separately.
Did bioaccess® run NCT05640401?
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. Country operator page: clinical trials in Ecuador (ARCSA / CEISH file).
Julio G. Martinez-Clark, CEO · bioaccess®