Names and roles cited from live ClinicalTrials.gov records NCT07461818, NCT06815939, NCT07538050, and NCT07232355 (overall-official, central-contact, and location-contact fields), checked 27 September 2026. Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current El Salvador and U.S. regulatory and ethics rules with qualified advisers. We do not reprint emails or phones and do not add affiliations beyond the registry strings cited here.
If you searched Karla Alfaro MD El Salvador, Dr Karla Alfaro clinical trial, Karla Alfaro Basic Health International, or “go direct to Karla Alfaro,” you followed investigator and contact strings ClinicalTrials.gov publishes. The work visible on those records is cervical cancer screening and pre-cancer treatment in El Salvador. A named principal investigator is not a first-in-human (FIH) medical-device contract research organization (CRO), and a personal reply is not the operator of the national file.
bioaccess®’s position is simple and it is not adversarial: the investigator is part of the site. The CRO still owns the Superintendencia de Regulación Sanitaria (SRS) and Comité Nacional de Ética de la Investigación en Salud (CNEIS) filings, investigational import, insurance, ISO 14155 monitoring, and the 21 CFR 812.28 package.
Registry roles, copied as listed (checked 27 September 2026)
Registry count: ALL 4 / DEVICE 2. All four records are listed as RECRUITING.
| Record | Sponsor | Type / intervention | Status | Role(s) listed for Karla Alfaro |
|---|---|---|---|---|
| NCT07461818 (POC) | Basic Health International, Inc. | Interventional; IRIS™ Thermal Ablation Device (DEVICE); estimated 5,000 | RECRUITING | Overall PRINCIPAL_INVESTIGATOR (affiliation Basic Health International, Inc.), shared with Rachel Masch, MD; central CONTACT |
| NCT06815939 (OPTICS) | DL Analytics | Interventional screening; interventions include the EVA System (DEVICE); estimated 10,000 | RECRUITING | Overall PRINCIPAL_INVESTIGATOR (affiliation Basic Health International, Inc.), shared with David Levitz, PhD (DL Analytics); site PRINCIPAL_INVESTIGATOR and CONTACT at “Ministerio de Salud,” San Salvador |
| NCT07538050 (SCALE AIM 2) | The Cleveland Clinic | Interventional; same-day screen and treat (BEHAVIORAL); estimated 1,000 | RECRUITING | Site PRINCIPAL_INVESTIGATOR and CONTACT (listed as “Karla Alfaro, MD, MPH”) at “Ministry of Health Clinics,” San Salvador |
| NCT07232355 (PROGRESS) | Atila Biosystems Inc. | Observational; estimated 5,000 | RECRUITING (see note) | Site CONTACT at Basic Health International, San Salvador |
Notes from the records themselves: OPTICS lists an estimated primary completion of 31 July 2026, which has passed, and an estimated study completion of 31 December 2026. PROGRESS lists estimated completion in June 2026, which has passed, and was last updated 19 November 2025, so its recruiting status is unconfirmed. SCALE AIM 2 started 16 April 2026. POC started 1 January 2026. None of the four records calls itself first-in-human, and none names a CRO.
Facility intercept for the site she is most often tied to on the registry: Basic Health International San Salvador. The Ministry of Health locations are listed only as generic strings (“Ministerio de Salud,” “Ministry of Health Clinics”), so we do not name a specific clinic.
The contact is the contact. The CRO is the operator.
What a named investigator can typically do when a sponsor “goes direct”:
- Discuss investigator interest and whether a protocol fits an existing service.
- Share local research rules and how the cases would physically run.
- Estimate local visit, staffing, and procedure effort for the cases they will run.
What a contact is not built to own for an investigational device:
- SRS authorization and the CNEIS packet, filed in parallel on the national digital platform.
- Investigational import and device accountability — see importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent a premium here.
- ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF).
- The 21 CFR 812.28 package. Eligibility is not clearance, and a site agreement does not produce it.
Going direct is how you confirm a room and a person. It is not how you open an investigational file.
Regulator, ethics, timeline, and cost (published figures)
These lines are copied from the published bioaccess® post El Salvador first-in-human cost and timeline vs the United States, not re-averaged here:
- The live El Salvador hub already publishes a 30–60 day study-startup band via parallel review by the Superintendencia de Regulación Sanitaria (SRS) and the Comité Nacional de Ética de la Investigación en Salud (CNEIS) on one digital platform. That band is investigation authorization plus ethics — not commercial registro.
- SRS replaced the former Dirección Nacional de Medicamentos (DNM) in August 2024. Ethics stays centralized at CNEIS.
- The El Salvador hub already publishes roughly 60% cost savings versus equivalent U.S. programs, plus a dollarized (U.S. dollar) economy. That is orientation from the country page, not a formal study for your device.
Ask for a study-specific calendar before you put a single date on a board slide. A site email is not an SRS authorization. Trial authorization and commercial registro are separate files; see CNEIS/SRS trial authorization vs registro.
All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Foreign clinical data can be eligible for U.S. Food and Drug Administration (FDA) submission and review under 21 CFR 812.28. Eligibility is not clearance or approval. See OUS FIH and FDA IDE.
Do not smear the investigator
Karla Alfaro, MD is a named principal investigator on public cervical-screening and pre-cancer treatment records in El Salvador. That is evidence of a person doing registered research, not a punchline. Cite the roles as listed. Hire the operator. Activate a site only if it fits.
Colombia note
Colombia remains a strong market-access geography and a historical first-in-human geography for bioaccess®. The public line still stands: INVIMA clinical-trial approval timelines have become unpredictable, so bioaccess® does not currently recommend Colombia for new first-in-human execution. We pick the country the device needs.
Frequently asked questions
Can I email Karla Alfaro, MD directly about a device study?
You can try through whatever channel the public registry exposes. A named investigator can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your SRS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager.
What roles does ClinicalTrials.gov show for her?
Overall PRINCIPAL_INVESTIGATOR on NCT07461818 and NCT06815939; central CONTACT on NCT07461818; site PRINCIPAL_INVESTIGATOR and CONTACT on NCT06815939 and NCT07538050; site CONTACT on NCT07232355.
Did bioaccess® run any of these studies?
No public bioaccess® page says so, and the records do not name a CRO. We will not invent that claim.
Next step
Start as the operator: contact bioaccess® or First-in-Human CRO. Country system: clinical trials in El Salvador. Facility sibling: Basic Health International San Salvador.