Vantage Clinical in Kazakhstan, and Where Latin America Fits

General information, not legal or regulatory advice. bioaccess® does not speak for Vantage. Statements about Vantage are attributed to its public website (vantage-ct.com) and its newsletter, The Vantage Brief, as of 28 September 2026. Confirm any detail that matters to your program with Vantage directly.

If you searched Vantage Clinical, Vantage Kazakhstan, or vantage-ct, you are probably weighing Kazakhstan for an early-phase clinical trial. This page does three things. It separates the Kazakhstan platform from a U.S. site network with a similar name. It summarizes what Vantage publicly says it offers. And it explains where Latin America, and bioaccess®, The First-in-Human CRO (contract research organization), fit when your program includes a medical device first-in-human (FIH) study.

First, which “Vantage”?

Two unrelated organizations show up for this search:

• Vantage Clinical (vantage-ct.com). Describes itself as sovereign-backed clinical trial infrastructure in Kazakhstan, built by biotech operators and investors. It lists locations in New York, Dubai, and Astana, and its site footer uses the name “Vantage Clinical Trials.” The Vantage Brief lists Charlie Regis, Almas Kenessary, and Zach Lomis as co-founders and partners, and Didar Bitmanov as chief operating officer (COO).
• Vantage Clinical Trials (vantagetrials.com). An independent clinical research site network in the Tampa Bay area of Florida, founded in 2018, with sites in Tampa, St. Petersburg, and The Villages.

This page is about the first one.

What Vantage says it offers in Kazakhstan

Vantage calls itself “the Kazakhstan layer”: the in-country platform, while sponsors keep flexibility on which CRO they use. Its website lists four parts:

• Government integration. Direct ministerial relationships and sovereign backing.
• Site and principal investigator (PI) network. Government-owned hospitals, Joint Commission International (JCI)-accredited facilities, and in-country site contracting, qualification, and activation.
• Accelerated recruitment. A centralized digital health database that Vantage says covers 20 million citizens.
• Regulatory navigation. Local approvals coordinated with Kazakhstan’s National Center for Drugs and Medical Devices Evaluation, with protocols built around International Council for Harmonisation (ICH) E6(R2) Good Clinical Practice (GCP).

Vantage describes itself as CRO-agnostic. Sponsors can bring their existing CRO, or Vantage coordinates with global CROs. Its newsletter names Tigermed as its global CRO partner. Its feasibility form covers first-in-human and proof-of-concept (POC) studies through Phase 3. Its June 2026 newsletter describes a first-in-human feasibility study of a bioresorbable peripheral vascular scaffold at a national hospital in Astana.

Vantage also publishes performance figures for Kazakhstan, such as 2–3x faster enrollment, 20–30% of Western cost, and 250+ completed and ongoing trials in the country. Those are Vantage’s figures. bioaccess® has not independently checked them, and we do not repeat them as our own. If a number matters to your budget, ask Vantage what it is based on.

Where Latin America fits

Kazakhstan and Latin America are not an either/or choice. They can answer different questions in an early-stage plan. bioaccess® has focused on first-in-human and early feasibility studies (EFS) since 2010. Most of our sponsors are U.S. medical device startups. We anchor on U.S. regulatory strategy and run studies across a defined list of 19 Latin American and Caribbean countries.

Three situations where Latin America is worth a look alongside a Kazakhstan plan:

1. Device-first programs. If your first human milestone is a device FIH or EFS, Latin America offers pre-qualified sites with small-cohort device experience, in time zones close to the U.S. Later-phase or larger cohorts can go wherever your regulatory strategy points, Kazakhstan included.
2. A second geography. Early-phase plans often stall for reasons unrelated to the science: a site’s calendar, an import permit, a regulator’s queue. A second country in a different region lowers single-country risk.
3. Hands-on oversight from the U.S. Some sponsor teams want to be in the room for the first cases. Short flights and overlapping working hours make that practical in Latin America.

Neither region is automatically faster or cheaper for every protocol. Match the geography to the device, the U.S. Food and Drug Administration (FDA) pathway, and what your investors need to see.

At a glance

FDA and foreign data, briefly

FDA does not keep a country scorecard. For drugs and biologics, FDA considers foreign clinical data under 21 CFR 312.120. For devices, 21 CFR 812.28 lets FDA accept data from studies outside the U.S. to support an investigational device exemption (IDE) or a marketing submission, when the study followed GCP (for devices, usually ISO 14155, the International Organization for Standardization standard for device trials), had independent ethics review and informed consent, and FDA can validate the data, including by inspection if needed. Eligibility is not clearance or approval. Plan the bridge with FDA early, usually through a Pre-Submission meeting. More detail: Does the FDA accept clinical data from Latin America? and Can first-in-human data from outside the U.S. support an FDA IDE submission?

Related pages

• Kazakhstan as a first-in-human destination
• Other Eurasia destinations: Georgia, Uzbekistan, Armenia, Moldova
• bioaccess®, The First-in-Human CRO and countries we serve

Frequently asked questions

Is Vantage Clinical the same company as Vantage Clinical Trials in Florida?

No. Vantage Clinical (vantage-ct.com) is a clinical trial platform focused on Kazakhstan, with offices listed in New York, Dubai, and Astana. Vantage Clinical Trials (vantagetrials.com) is an independent research site network in the Tampa Bay area of Florida, founded in 2018. They are separate organizations.

Is bioaccess® part of Vantage?

No. bioaccess® and Vantage are independent companies. bioaccess® is The First-in-Human CRO, headquartered in Miami and focused on the U.S. and Latin America. If your plan includes both Kazakhstan and Latin America, tell us and we will coordinate with your Kazakhstan partner.

Does Vantage run medical device trials?

Vantage’s feasibility form lists first-in-human and proof-of-concept studies through Phase 3, and its June 2026 newsletter describes a first-in-human feasibility study of a bioresorbable peripheral vascular scaffold at a national hospital in Astana. For specifics on devices in Kazakhstan, ask Vantage directly.

Will the FDA accept data from Kazakhstan or Latin America?

FDA decides case by case, not by country. It considers foreign drug and biologic data under 21 CFR 312.120 and foreign device data under 21 CFR 812.28, looking at GCP compliance, ethics review, informed consent, and whether it can validate the data. Eligibility is not clearance or approval, so align the plan with FDA early, usually through a Pre-Submission meeting.

Can one program use both Kazakhstan and Latin America?

Yes. Sequencing the two regions is usually simpler than running both under one protocol at the same time, because each has its own regulator, ethics committees, language, and import logistics. One sequence to consider: a device first-in-human or early feasibility study in Latin America, then larger or later-phase cohorts wherever your regulatory strategy points.

How do I start a conversation?

For Kazakhstan feasibility, contact Vantage at info@vantage-ct.com. For a device first-in-human or early feasibility study in Latin America, schedule time with Julio Martinez-Clark, CEO of bioaccess®, at bioaccessla.com/schedule-time-with-julio-martinez-clark.

Next step

Planning a device first-in-human study and weighing Kazakhstan, Latin America, or both? Schedule time with Julio Martinez-Clark, CEO of bioaccess®.

Schedule time with Julio Martinez-Clark