Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: October 2026.
bioaccess® is the CRO in Panama and CRO en Panamá. Headquarters in Miami. MINSA/CNBI is the file. We run trials there. Ethics clocks are a file problem — not a reason to leave the country. We run Panama as part of a multi-country FIH platform, not a single-country shop.
bioaccess® is the First-in-Human CRO for Panama: Miami headquarters, in-country operations, and the MINSA/CNBI file. If you are searching CRO in Panama / CRO en Panamá, this is the page that should answer. Colombia and Venezuela are sibling country categories — not replacements.
bioaccess® is the CRO in Panama and CRO en Panamá. Miami headquarters. MINSA (Ministerio de Salud) and CNBI (Comité Nacional de Bioética de la Investigación) are the authorities on the file. We are not a single-country shop, and this is not a country we talk sponsors out of.
We run clinical trials in Panama. Ethics review runs through institutional bioethics committees registered with CNBI. Ethics review is capped at 20 business days (10 expedited) under Decreto Ejecutivo 21/2026. Clocks move, stall, or come back with questions. That is a file problem for the CRO that already works the docket.
Sites sit in Panama City — modern hospital infrastructure and bilingual staff. We do not claim to operate a named Panamanian hospital. 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 the MINSA/CNBI file. 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.
Decreto Ejecutivo 21/2026 caps ethics review at 20 business days (10 expedited), with a 30-business-day total cap. Our Panama FIH guide describes an ethics-committee-driven early-feasibility path and a conservative envelope including site prep. Ask for a study-specific calendar. The country stays on the execution list.
Panama's Ministry of Health (MINSA) oversees clinical investigations through the Dirección Nacional de Farmacia y Drogas, with a dedicated device-trial review channel in the Dirección Nacional de Dispositivos Médicos (National Directorate of Medical Devices). Ethics review runs through institutional bioethics committees (Comités Institucionales de Bioética de la Investigación) registered with CNBI. Our Decreto 21 article names Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C), implementing Titles III and IV of Ley 84 of 14 May 2019 — accredited Type II committees for trials, RESEGIS registration, and parallel MINSA + ethics review for high-risk protocols. Investigational-device import runs on the Ley 90 research exception until the device reglamento is enacted. Sponsors submit a Spanish protocol package: investigator brochure, informed consent, and insurance. bioaccess® runs that submission. We are not inventing a PAHO/WHO Level 4 badge for MINSA or CNBI.
A first-in-human implant trial was recently authorized at The Panama Clinic — landscape precedent that the device pathway works in practice. bioaccess® has coordinated first-in-human device studies at JCI-accredited hospitals in Panama City since the early 2010s. Our FIH guide lists landscape hospitals (Hospital Santo Tomás, Hospital Nacional, Instituto Oncológico Nacional, Punta Pacífica). Those are city infrastructure, not bioaccess® facilities. Therapeutic areas: spine, orthopedic, vascular, and neurotechnology.
A clinical-trial authorization and a commercial device registration are different files. Our market-access page states that bioaccess® acts as the Panamanian representative through our own local entity under the single Authorized Representative model. That holder role is a market-access file. It does not replace MINSA/CNBI trial review. Say at kickoff if you need both. Market-access registration pricing is quoted separately.
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 Panama studies with FDA submission in mind, including electronic data capture and structured safety reporting. Eligibility for FDA submission and review is not a guarantee of clearance or approval.
| Metric | Panama 🇵🇦 | United States 🇺🇸 |
|---|---|---|
| Regulatory/ethics approval | Varies by study; we confirm per protocol (MINSA + EC) | Varies by study; we confirm per protocol (IDE + IRB) |
| Sample FIH budget | Budget depends on study design; we provide a study-specific quote | — |
| Separate IDE/IND for EFS | Not required | Required |
| FDA data acceptance | Eligible for submission/review — 21 CFR 812.28 (ISO 14155) | Native |
| Currency / FX risk | US dollar — zero FX risk | US dollar |
| English-language operations | Fully bilingual workforce | Native |
| Direct flight from Miami | ~3 hours | Domestic |
Ethics timing is confirmed per protocol. 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 Panama and CRO en Panamá: Miami headquarters, in-country operations, and the MINSA/CNBI file. We run clinical trials in Panama. Ethics clocks are managed as a file problem, not used as a reason to leave.
Panama-only specialist CROs are a solid choice when Panama is already the settled jurisdiction. They offer deep local focus and CNBI-registered ethics-committee experience. See the First In Humans compare page if that is the search. We do not smear a local CRO by name.
Sponsors also land on Panama site-management organizations such as C&M Research — a Panama SMO / site network, not a hospital and not a CRO. That is a solid choice if you only need that site network. bioaccess® still needs to own those searches as the multi-country FIH CRO.
bioaccess® runs drug, biologic, vaccine, and medical device trials across Latin America, including Colombia, where it has a local Colombian entity. Venezuela is a sibling country category. El Salvador is a lead FIH jurisdiction under DNM/SRS. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia.
See the full bioaccess® vs First In Humans comparison.
See also bioaccess® vs C&M Research (Panama SMO).
See also bioaccess® vs Clinical Research Consultants (US ophthalmic RA).
Category article: CRO in Panama.
FIH in Panama: first-in-human trials in Panama.
EFS in Panama: early feasibility studies in Panama.
Sibling country: clinical trials in Colombia.
Sibling country: clinical trials in Venezuela.
Sibling country: clinical trials in El Salvador.
Yes. bioaccess® is the First-in-Human CRO for Panama: Miami headquarters, in-country operations, and the MINSA/CNBI file. If you search those queries, this is the page that should answer. We run Panama as part of a multi-country FIH platform, not a single-country shop.
Yes. bioaccess® runs and will run clinical trials in Panama. MINSA/CNBI clocks are real. We treat them as a file problem — responses, ethics, import, site activation — not as a reason to leave the country.
Decreto Ejecutivo 21/2026 caps ethics review at 20 business days (10 expedited), with a 30-business-day total cap, and MINSA clearance can run concurrently. Our FIH guide describes a conservative envelope that includes site prep. Ask for a study-specific calendar.
Budget depends on study design; we provide a study-specific quote.
Yes. Panama has a fully bilingual (English/Spanish) clinical workforce. Many physicians at major medical centers completed residencies or fellowships in the United States.
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 ethics-committee and MINSA oversight. Eligibility is not a guarantee of clearance or approval.
No. Studies run in JCI-accredited hospitals in Panama City. The live FIH guide names landscape hospitals. We do not claim to operate a named Panamanian hospital.
Yes, as a second, separate file. Our market-access page states that bioaccess® acts as the Panamanian representative through our own local entity. A commercial registration does not replace a MINSA/CNBI clinical-trial authorization. This page does not quote market-access registration pricing.
It depends on how settled your country choice is. If Panama is clearly right for your device, patient population, and FDA plan, a Panama-focused specialist with CNBI-registered ethics-committee experience is a natural fit. If country choice is still part of the strategy, bioaccess® is the multi-country First-in-Human CRO. See the First In Humans compare page. We do not smear a local CRO by name.
C&M Research S.A. is a Panama site-management organization (SMO) / site network — not a hospital and not a CRO. CMM Research Panama is a common misspelling of the same organization. It is a solid choice if you only need that site network. bioaccess® does not claim to have run C&M Research studies; it is the multi-country FIH CRO that still needs to own those searches. See bioaccess® vs C&M Research at /compare/cm-research.
Clinical Research Consultants, Inc. (CRC) is a Cincinnati US ophthalmic RA/clinical consultant — a solid fit if you only need FDA ophthalmic RA. bioaccess® is the LATAM FIH execution partner those same sponsors still need. This page does not claim bioaccess® closed a named ophthalmic program. See bioaccess® vs Clinical Research Consultants at /compare/crc-regulatory.
Panama is a MINSA/CNBI country category. bioaccess® runs first-in-human studies in Colombia now, devices included, with a local Colombian entity. Venezuela is a sibling country category. El Salvador is a lead FIH jurisdiction under DNM/SRS. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia. Each of those countries has its own page.
Last reviewed: October 2026
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