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 ISP, 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 Clínica INDISA Santiago as a bioaccess® client.
If you searched Clínica INDISA Santiago first-in-human, Clinica Indisa clinical trial, INDISA Chile CRO, INDISA Clínica da Familia CRO, or “go direct Clínica INDISA Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Clínica INDISA / Clinica Indisa / INDISA in Santiago, Chile, is a real named private clinic-campus string on ClinicalTrials.gov (aliases include INDISA Clínica da Familia, INDISA, Clinica Indisa, Clínica INDISA, Clínica Indisa). It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.
bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns ISP, 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 clinic still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Santiago Clínica INDISA campus. It is DISTINCT from Clínica Colonial Santiago, Clínica Alemana de Santiago, Clínica Las Condes Santiago, Clínica MEDS La Dehesa Santiago, and Hospital FACH Santiago. Sharing Santiago metro — and even sharing Levita NCT rows with sibling campuses — is not a license to collapse them. Clínica INDISA is not Clínica Colonial. Clínica INDISA is not Clínica Alemana. Clínica INDISA is not Clínica Las Condes. Clínica INDISA is not Clínica MEDS. Clínica INDISA is not Hospital FACH.
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. We do not invent DEVICE n by unioning all aliases without disclosure. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- INDISA Clínica da Familia (Santiago, Chile) — strongest feasibility anchor: NCT01578642 (Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter…; COMPLETED).
- INDISA (Santiago, Chile) — DEVICE initial clinical evaluation: NCT01927562 (Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes; COMPLETED).
- Clinica Indisa (Santiago, Chile) — modern device cluster: NCT05353777 (Clinical Evaluation of the Levita Robotic Platform; COMPLETED). Shared with FACH / Tisné / San Borja — do not claim as INDISA-only.
- Clínica INDISA (Santiago, Chile) — NCT07017517 (NLRP3 Inflammasome and Physical Therapy…; RECRUITING; DEVICE + BEHAVIORAL). Cite carefully; not a FIH title. Do not treat BEHAVIORAL-only framing as device FIH evidence.
List aliases separately: INDISA Clínica da Familia, INDISA, Clinica Indisa, Clínica INDISA, Clínica Indisa. Strongest FIH/feasibility anchor remains NCT01578642. Modern device cluster includes NCT05353777 (Levita).
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 clinic 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 clinic as a client site.
That is the leak: a founder searching Clínica INDISA Santiago first-in-human finds feasibility and Levita DEVICE rows without finding ISP. A named clinic campus is still a site. An NCT location row is not a CRO. A private-clinic brand story is still not a CRO.
The site is the site. The CRO is the operator.
A named clinic 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 clinic 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 clinic is not built to own for an investigational device:
- ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Clínica INDISA is not a Clínica Colonial file, not a Clínica Alemana file, not a Clínica Las Condes file, not a Clínica MEDS file, and not a Hospital FACH 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 ISP actually works (the short version)
Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.
Ask for a protocol-specific calendar. A hospital email is not ISP 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
Clínica INDISA Santiago is a serious named Chilean private campus on the public registry — metabolic endoscopy feasibility (NCT01578642) and Levita DEVICE rows are real facility evidence, not a punchline. Do not invent a PI. Do not invent DEVICE n by silent alias union. Do not treat NCT07017517 as a FIH title. 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 ISP / 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 Clínica INDISA Santiago directly for a device FIH?
You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ISP 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 clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as Clínica Alemana, Clínica Las Condes, Clínica MEDS, or Hospital FACH?
No. clinica-alemana-santiago-fih, clinica-las-condes-santiago-fih, clinica-meds-dehesa-santiago-fih, and hospital-fach-santiago-fih are distinct Santiago campuses. This page is Clínica INDISA / Clinica Indisa / INDISA only.
Did bioaccess® run NCT01578642, NCT01927562, NCT05353777, or NCT07017517?
No. We cite them as facility evidence. We will not invent a sponsor or a PI. We will not claim bioaccess® ran these studies. NCT05353777 also names other Chile sites; do not treat it as INDISA-only. NCT07017517 is DEVICE + BEHAVIORAL and is not cited here as a FIH title.
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. Santiago siblings (do not merge): Clínica Colonial Santiago, Clínica Alemana de Santiago, Clínica Las Condes Santiago, Clínica MEDS La Dehesa Santiago, Hospital FACH Santiago.
Julio G. Martinez-Clark, CEO · bioaccess®