bioaccess® is not affiliated with Clinical Accelerator. Facts about Clinical Accelerator come from its public website and ClinicalTrials.gov, checked 28 September 2026. General information, not legal or regulatory advice.
If you searched for Clinical Accelerator, you are probably a MedTech founder planning a first-in-human (FIH) study or an early feasibility study (EFS) and deciding where to run it. Clinical Accelerator is an established medical device contract research organization (CRO) in Eastern Europe, the Caucasus and Central Asia. bioaccess® runs device FIH and EFS programs in Latin America. This page compares the two regions honestly. Both can produce credible early data.
What Clinical Accelerator says about itself
From its own public pages:
- It describes itself as “The Sponsor-Aligned CRO for First-in-Human and Early Feasibility Trials” for novel medical devices.
- Its homepage coverage map lists Armenia, Bulgaria, Czechia, Georgia, Lithuania, Poland, Serbia, Ukraine and Uzbekistan. The team page names country leads for Georgia and Uzbekistan, plus clinical operations for Lithuania and the EU.
- The homepage cites 200+ FIH and EFS trials run, 60+ dedicated clinical sites, a 150MM+ patient population, and about 60 days on average from kickoff to first patient in (FPI). It adds that timelines vary by indication and country.
- Its experience page centers on cardiovascular devices (heart failure, transcatheter valves, interatrial shunts, renal denervation, electrophysiology, neurovascular), plus oncology and other areas.
- ClinicalTrials.gov names Clinical Accelerator as a collaborator on nine records. Their sites include Georgia, Uzbekistan and Ukraine.
These are Clinical Accelerator’s own statements. We have not audited them and we are not disputing them. Kazakhstan and Moldova are not on its map. Our country guides for them are linked below.
The same U.S. data-acceptance rule applies to both regions
Under 21 CFR 812.28, the U.S. Food and Drug Administration (FDA) accepts device data from outside the United States to support an investigational device exemption (IDE), 510(k), De Novo request or premarket approval (PMA) application. The study must be well designed and well conducted under good clinical practice (GCP), including independent ethics committee (IEC) review and informed consent, and FDA must be able to validate the data, by onsite inspection if it decides one is needed. If a PMA relies only on foreign data, 21 CFR 814.15 adds that the data must apply to the U.S. population and U.S. medical practice.
The rule does not favor or penalize any country. What counts is protocol quality, conduct under ISO 14155 (the international GCP standard for device investigations), monitoring and data integrity. More: FDA acceptance.
Where Eastern Europe, the Caucasus and Central Asia are strong
- Recent device-specific rules. Georgia adopted a technical regulation for device clinical research in October 2023 (Resolution No. 386), and a published summary says it references ISO 14155:2020 and International Council for Harmonisation (ICH) GCP. A new Uzbek regulation on device clinical trials took effect on 26 February 2026. Serbia’s Medicines and Medical Devices Agency (ALIMS) takes the agency application and the national ethics application at the same time.
- Short published approval clocks. Moldova’s medicines and device agency says it issues its opinion within 30 working days of a complete application. CROs working in Georgia publish approval timelines of under two months.
- An early-device track record. ClinicalTrials.gov lists 14 Georgia records whose primary purpose is marked “device feasibility.” Among the countries on this page, only Brazil has more (15).
- Specialist cardiovascular depth, a real advantage for structural heart and heart failure devices.
Where Latin America is strong
- Your time zone. Panama City and Bogotá are on UTC−5 (Coordinated Universal Time minus five hours) and Santiago and São Paulo on UTC−3, 0–2 hours from U.S. Eastern time. Belgrade to Tashkent runs about 6–10 hours ahead.
- Large patient populations. World Bank 2024 figures: Brazil about 212 million, Mexico about 131 million, Argentina about 46 million. On ClinicalTrials.gov, Brazil has 1,170 interventional device records, Mexico 244 and Chile 199.
- Published clocks. Our Panama hub publishes ethics approval in 3–5 weeks, with MINSA (Ministry of Health) clearance available at the same time, and a 6–8 week average to first patient with bioaccess® coordination. Our Brazil hub publishes 6–10 weeks for ANVISA (Agência Nacional de Vigilância Sanitária) plus ethics review. Argentina’s ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) regulates device clinical investigations under Disposition 969/1997.
- One team from FIH to the United States. bioaccess® is headquartered in Miami. Its sister organization, Amavita Research Services, runs a Miami clinical research site for device and early feasibility studies.
Latin America has trade-offs too: Spanish or Portuguese documents, investigational import permits, and uneven regulator predictability. Colombia’s INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) clinical-trial timelines have recently been harder to forecast. Small countries such as Panama (about 4.5 million people) carry the same narrow-pool risk as Georgia or Armenia.
Side-by-side comparison
| Factor | Eastern Europe, Caucasus and Central Asia | Latin America (bioaccess®) |
|---|---|---|
| Example pathways | Georgia: agency registration certificate plus a local ethics committee opinion at each site. Kazakhstan: national expert review, bioethics commission, then a Ministry of Healthcare permit. Serbia: ALIMS and national ethics filed together | Panama: MINSA plus ethics committees registered with the national bioethics committee (CNBI). Brazil: ANVISA resolution RDC 837/2023 plus institutional research ethics committees (CEPs). Argentina: ANMAT plus ethics |
| Published timing | Clinical Accelerator: about 60 days kickoff to FPI (its average). Moldova: agency opinion within 30 working days of a complete file | Panama: 3–5 week ethics and a 6–8 week average to first patient (bioaccess® hub). Brazil: 6–10 weeks, ANVISA plus ethics |
| GCP standard | ISO 14155 cited in Georgian and Kazakh rules | bioaccess® runs device studies under ISO 14155 |
| FDA use of data | 21 CFR 812.28 (same rule) | 21 CFR 812.28 (same rule) |
| Interventional device records on ClinicalTrials.gov (28 Sep 2026) | Serbia 97, Georgia 90, Ukraine 54, Armenia 36, Kazakhstan 26, Uzbekistan 23, Moldova 3 | Brazil 1,170, Mexico 244, Chile 199, Colombia 118, Argentina 111, Panama 39 |
| Time difference from U.S. Eastern | About 6–10 hours ahead | About 0–2 hours |
| Languages for documents | Georgian, Armenian, Kazakh or Russian, Uzbek, Romanian, Ukrainian, Serbian | Spanish, Portuguese |
Registry counts cover all interventional device studies, not just FIH. They show footprint, not quality.
Questions to ask any FIH CRO, in either region
- Which regulator and ethics body will review my device class, and who is the legal applicant or local representative?
- Can I have a written, study-specific calendar, including what pauses the clock?
- How many patients meeting my inclusion criteria did the named sites treat last year? Strict criteria shrink eligible pools fast, especially in small countries or when one hospital dominates referrals.
- Which implanting physicians will do the cases, and what similar devices have they used?
- How will monitoring, data and safety reporting be packaged for 812.28? Who handles import, insurance and translations?
See also: how to compare CRO proposals for FIH trials.
Where bioaccess® fits
If Clinical Accelerator’s region and cardiovascular focus suit your device, it is a serious option. If you want a start in your own time zone, large Latin American populations, and one team that can carry the program into a U.S. early feasibility study, talk to us. See First-in-Human CRO and early feasibility studies.
Country guides: Georgia · Uzbekistan · Kazakhstan · Armenia · Moldova · Ukraine · Serbia
Frequently asked questions
Is bioaccess® affiliated with Clinical Accelerator?
No. They are independent companies working in different regions. This page relies only on Clinical Accelerator’s public website and ClinicalTrials.gov.
Will the FDA accept first-in-human data from Georgia or Uzbekistan?
The same rule, 21 CFR 812.28, applies to data from any country outside the United States. The study must follow GCP, including ethics review and informed consent, and FDA must be able to validate the data. Acceptance is decided case by case, and the rule does not favor one region over another.
Which region starts faster?
Both publish short clocks: Clinical Accelerator cites about 60 days on average from kickoff to first patient, and our Panama hub a 6–8 week average to first patient with bioaccess® coordination. Compare written, study-specific calendars, not averages.
Which countries does Clinical Accelerator cover?
Its homepage map lists Armenia, Bulgaria, Czechia, Georgia, Lithuania, Poland, Serbia, Ukraine and Uzbekistan. Please confirm current coverage with Clinical Accelerator directly.
Can I use both regions in one program?
Yes. Each country needs its own ethics and regulatory approvals. Collect the data to one protocol and one GCP standard.
Next step
Want an honest read on which region fits your device? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.
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