Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: October 2026.
bioaccess® is the CRO in El Salvador and CRO en El Salvador. Headquarters in Miami. El Salvador is a lead first-in-human jurisdiction. We run trials there. DNM/SRS clocks are a file problem — not a reason to leave the country.
bioaccess® is the First-in-Human CRO for El Salvador: Miami headquarters, in-country operations, and a lead FIH jurisdiction under DNM/SRS. If you are searching CRO in El Salvador / CRO en El Salvador, this is the page that should answer. Colombia and Venezuela are sibling country categories — not replacements.
bioaccess® is the CRO in El Salvador and CRO en El Salvador. Miami headquarters. El Salvador is a lead first-in-human jurisdiction. We run trials here, and this is not a country we talk sponsors out of.
We run clinical trials in El Salvador. The Superintendencia de Regulación Sanitaria (SRS), established in August 2024, replaced the Dirección Nacional de Medicamentos (DNM) as the national regulatory authority. SRS and CNEIS submissions run in parallel — two submissions coordinated on one timeline; there is no unified single-platform filing. The realistic submission-to-first-patient envelope is a study-specific timeline (we confirm it per protocol), with device import authorization as a separate SRS step. Clocks move, stall, or come back with questions. That is a file problem for the CRO that already works the docket.
Sites sit in San Salvador — the capital network, including Hospital El Salvador as published landscape infrastructure, not a hospital we operate. Studies are designed with FDA submission in mind under 21 CFR 812.28. Eligibility of foreign data for FDA submission and review is not a guarantee of clearance or approval.
bioaccess® owns this category: Miami HQ, in-country operations, and a lead FIH jurisdiction under DNM/SRS. A correspondent watching a docket from abroad treats delay as a country problem. The CRO on the ground treats delay as responses, ethics alignment, investigational import, and site activation on one timeline. That is how Global Trial Accelerators™ is meant to run.
The realistic envelope is a study-specific timeline (we confirm it per protocol) from submission to first patient, with device import authorization as a separate SRS step. The SRS is the region's newest regulator (autonomous since August 2024); new regulators mean process friction, and this page builds the buffer instead of promising it away. Ask for a study-specific calendar. The country stays on the execution list as a first-in-human jurisdiction.
Clinical investigations in El Salvador sit under the Superintendencia de Regulación Sanitaria (SRS), successor to the Dirección Nacional de Medicamentos (DNM) since August 2024 under the Ley de la Superintendencia de Regulación Sanitaria (7 August 2024 — already on the market-access page). Ethics is centralized at the Comité Nacional de Ética de la Investigación en Salud (CNEIS). The site submits to SRS and CNEIS in parallel — two submissions, one timeline. The dedicated clinical-trials bill (Expediente 255-1-2025-1, entered January 2025) carries a favorable committee opinion but is not enacted. The operative inspection standard is the SRS October 2025 GCP-inspection guide, expressly covering device trials under ISO 14155. Device import authorization is a separate SRS step. Sponsors submit a Spanish protocol package. bioaccess® runs that submission. We are not inventing a PAHO/WHO Level 4 badge for DNM or SRS.
San Salvador's hospital network anchors the public site list . Hospital El Salvador is a flagship public hospital with radiological and surgical capacity — landscape infrastructure, not a bioaccess® facility. Therapeutic areas: cardiovascular, ophthalmic, urological, and orthopedic device studies.
El Salvador FIH infrastructure
A clinical-trial authorization and a commercial device registration are different files. Our market-access page states that bioaccess® acts as the Salvadoran legal representative through our own local entity. That holder role is a market-access file. It does not replace SRS/CNEIS trial review. Say at kickoff if you need both. Market-access registration pricing is quoted separately.
El Salvador DNM/SRS registration
Foreign first-in-human data is eligible for FDA submission and review when studies comply with good clinical practice as 21 CFR 812.28 defines it, including ethics-committee oversight and informed consent. bioaccess® designs El Salvador studies with FDA submission in mind. Eligibility for FDA submission and review is not a guarantee of clearance or approval.
| Metric | El Salvador 🇸🇻 | United States 🇺🇸 | Europe (EU) 🇪🇺 |
|---|---|---|---|
| Submission to first patient | Varies by study; we confirm per protocol (SRS + CNEIS, separate submissions) | Varies by study; we confirm per protocol (IDE + IRB) | Varies by study; we confirm per protocol (per-country CA + EC) |
| Cost vs. US program | Lower (study-specific quote) | Baseline | Lower (study-specific quote) |
| Regulatory + ethics submission | Parallel (one digital platform) | Sequential | Sequential |
| FDA data acceptance | Eligible for submission/review — 21 CFR 812.28 (ISO 14155) | Native | Yes, with justification |
| Currency / FX risk | US dollar — zero FX risk | US dollar | Euro / local — FX exposure |
| Ethics review model | Centralized (CNEIS) | Local IRBs | Per-country ECs |
Ranges vary by indication, study complexity, and monitoring. Eligibility under 21 CFR 812.28 is not FDA clearance or approval.
bioaccess® is the CRO in El Salvador and CRO en El Salvador: Miami headquarters, in-country operations, and a lead first-in-human jurisdiction under DNM/SRS. We run clinical trials in El Salvador. DNM/SRS clocks are managed as a file problem, not used as a reason to leave.
Colombia is a sibling country category with a local Colombian entity. Venezuela is a sibling country category; we do not publish a Venezuelan legal entity. Panama is MINSA/CNBI.
See the First-in-Human CRO.
Category article: CRO in El Salvador.
FIH in El Salvador: first-in-human trials in El Salvador.
EFS in El Salvador: early feasibility studies in El Salvador.
Sibling country: clinical trials in Colombia.
Sibling country: clinical trials in Venezuela.
Sibling country: clinical trials in Panama.
Yes. bioaccess® is the First-in-Human CRO for El Salvador: Miami headquarters, in-country operations, and a lead FIH jurisdiction under DNM/SRS. If you search those queries, this is the page that should answer.
Yes. bioaccess® runs and will run clinical trials in El Salvador. DNM/SRS clocks are real. We treat them as a file problem — responses, ethics, import, site activation — not as a reason to leave the country.
The realistic envelope is a study-specific timeline (we confirm it per protocol) from submission to first patient, with device import authorization as a separate SRS step. This page does not claim a timeline that varies by study (we confirm it per protocol). Ask for a study-specific calendar.
The Superintendencia de Regulación Sanitaria (SRS) is El Salvador's National Regulatory Authority, established in August 2024. It replaced the former Dirección Nacional de Medicamentos (DNM) under the Ley de la Superintendencia de Regulación Sanitaria (7 August 2024).
Costs depend on study design and are typically lower than equivalent US clinical programs, driven by site and investigator fees and a dollarized economy; we provide a study-specific quote.
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets the GCP conditions in that rule, including SRS authorization and CNEIS ethics approval. Eligibility is not a guarantee of clearance or approval.
No. Hospital El Salvador is landscape infrastructure — the country's largest public hospital, with a published radiological center. We do not claim to operate it.
Yes, as a second, separate file. Our market-access page states that bioaccess® acts as the Salvadoran legal representative through our own local entity. A commercial registration does not replace an SRS/CNEIS clinical-trial authorization. This page does not quote market-access registration pricing.
El Salvador is a lead FIH country category. Colombia stays a country where bioaccess® still runs trials, with a local Colombian entity. Venezuela is a second country category. Panama is MINSA/CNBI. Each of those countries has its own page.
Last reviewed: October 2026
All countries we serve · Contact bioaccess® · First-in-Human CRO