Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
bioaccess® is the CRO in Costa Rica and CRO en Costa Rica. Headquarters in Miami. We run clinical trials there. CONIS and accredited-CEC clocks are a file problem — not a reason to leave the country.
bioaccess® is the First-in-Human CRO for Costa Rica: Miami headquarters and in-country operations on the CONIS / CEC file. If you are searching CRO in Costa Rica / CRO en Costa Rica, this is the page that should answer. Colombia is a second country category with its own local Colombian entity — not a replacement.
bioaccess® is the CRO in Costa Rica and CRO en Costa Rica. Miami headquarters. We run first-in-human device studies under Ley N.° 9234. That is the operating identity — not a Costa Rican legal entity we do not publish, and not a country we talk sponsors out of.
CONIS (Consejo Nacional de Investigación en Salud), an organ of the Ministry of Health (Ministerio de Salud), is the national clinical-research authority. An accredited Comité Ético Científico (CEC) must give written approval before enrollment. Those are two legal acts. Clocks move when the Spanish file is incomplete. That is a file problem for the CRO that already works the docket — not a reason to take the study out of Costa Rica.
Typical combined ethics-plus-regulatory approval on this hub is already ~30–90 days. Approved studies pay a statutory 3% CONIS canon on the study budget. 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 CONIS / CEC file on one timeline. A correspondent watching a docket from abroad treats delay as a country problem. The CRO on the file treats delay as CEC questions, CONIS registration, the 3% canon, investigational import, and site activation. That is how Global Trial Accelerators™ is meant to run.
This hub already publishes ~30–90 days for combined ethics-plus-regulatory approval under Ley N.° 9234. The live activation calendar on this site is clearer: a CONIS-accredited CEC must approve the protocol in writing, and the approved project is then registered with CONIS. Registration is not a substitute for CEC approval. We will not invent a new median. Ask for a study-specific calendar. The country stays on the execution list.
Costa Rica FIH activation calendar
CONIS (Consejo Nacional de Investigación en Salud) is the national clinical-research authority and operates as an organ of the Ministry of Health (Ministerio de Salud). All biomedical research in Costa Rica is governed by the Biomedical Research Regulatory Law (Ley Reguladora de Investigación Biomédica, Ley N.° 9234), which defines sponsor obligations, investigator responsibilities, informed consent, ethics-committee accreditation, and inspection powers. Those names and that statute are already public on this hub. bioaccess® prepares the Spanish CONIS dossier and coordinates the file through start-up.
Before enrollment, every study must be approved by an accredited scientific ethics committee — Comité Ético Científico (CEC) — registered under Ley N.° 9234. Ethics review is conducted against ICH-GCP and, for medical devices, ISO 14155, with review of protocol, investigator brochure, informed consent, insurance coverage, and site qualifications. Typical combined ethics-plus-regulatory approval runs in the ~30–90 day range depending on device risk classification and dossier completeness. We do not operate a named Costa Rican hospital.
Under Ley N.° 9234, approved biomedical research pays a statutory 3% CONIS canon (levy) on the study budget. The live activation calendar already says: build it into the budget before you sign the site; the budget the CEC forwards and the budget used for the canon must match. Independent, non-commercial research can be treated differently; a sponsored device first-in-human is not that case. bioaccess® puts the canon in the sponsor budget from the outset. This hub does not quote LATAM Launch subscription pricing.
3% canon on the activation calendar
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 Costa Rica 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.
| Consideration | New clinical trial | Later Costa Rica registration |
|---|---|---|
| bioaccess® current recommendation | Actively executed. We run trials in Costa Rica. | Separate market-access file |
| Primary reason | CONIS / CEC clocks treated as a file problem | Already distinguished from FIH on the live activation calendar |
| Regulatory instrument | Ley N.° 9234 — CEC approval + CONIS registration | A commercial holder file is not a first-in-human permit |
| Already-published clock / levy | ~30–90 days ethics + regulatory; 3% CONIS canon | Holder / subscription pricing is not on this hub |
| Where to go next | This page / CRO in Costa Rica article | Activation calendar (FIH vs registration are different files) |
~30–90 days ethics-plus-regulatory approval, Ley N.° 9234, accredited CEC review, and the 3% CONIS canon are already published on this hub. Ranges vary by device complexity, therapeutic area, and dossier completeness. Eligibility under 21 CFR 812.28 is not FDA clearance or approval. This hub does not quote LATAM Launch subscription pricing.
bioaccess® is the CRO in Costa Rica and CRO en Costa Rica: Miami headquarters and in-country operations on the CONIS / CEC file. We run clinical trials in Costa Rica. Clocks are managed as a file problem, not used as a reason to leave.
Colombia is a second country category. bioaccess® still runs trials in Colombia with a local Colombian entity. This Costa Rica page does not replace that page and does not invent a Costa Rican legal entity.
See the First-in-Human CRO.
Category article: CRO in Costa Rica.
Activation calendar: CEC, CONIS registration, and the 3% canon.
Yes. bioaccess® is the First-in-Human CRO for Costa Rica: Miami headquarters and in-country operations on the CONIS / CEC file. We do not publish a Costa Rican legal entity on this page.
Yes. bioaccess® runs and will run clinical trials in Costa Rica. CONIS and CEC clocks are real. We treat them as a file problem — Spanish dossier, CEC questions, CONIS registration, the 3% canon, import, site activation — not as a reason to leave the country.
This hub already publishes ~30–90 days for typical ethics-plus-regulatory approval, depending on device risk classification and dossier completeness. The live activation calendar treats CEC approval and CONIS registration as sequential gates, not one ministry slogan. Ask for a study-specific calendar. We will not invent a new median here.
CONIS (Consejo Nacional de Investigación en Salud), an organ of the Ministry of Health (Ministerio de Salud), is Costa Rica's national clinical-research authority. All biomedical research is governed by the Biomedical Research Regulatory Law (Ley Reguladora de Investigación Biomédica, Ley N.° 9234).
Every study must be approved by an accredited scientific ethics committee — Comité Ético Científico (CEC) — registered under Ley N.° 9234. Ethics review is conducted against ICH-GCP and, for medical devices, ISO 14155.
Under Ley N.° 9234, approved biomedical research pays a statutory 3% CONIS canon (levy) on the study budget. It is not a CRO fee. bioaccess® builds this into sponsor budgets from the outset so the number the CEC forwards matches the number paid at registration.
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 CONIS / Ministry of Health authorization and accredited-CEC ethics approval. bioaccess® designs every Costa Rica study with that FDA conversation in mind. Eligibility is not a guarantee of clearance or approval.
No. We contract sites. We do not claim to operate a named Costa Rican hospital, and we do not publish a Costa Rican legal entity on this page.
Costa Rica is a country we run first-in-human work in. Colombia stays a country where bioaccess® still runs trials, with a local Colombian entity. Do not read this page as a replacement for Colombia.
Last reviewed: July 2026
All countries we serve · Contact bioaccess® · First-in-Human CRO