ADAX INTERNATIONAL, d.o.o.

What ADAX INTERNATIONAL, d.o.o. does

ADAX INTERNATIONAL, d.o.o. is a Slovenia-headquartered clinical research organization (CRO) that supports pharmaceutical and medical device companies across clinical trial execution, regulatory affairs, and professional training. Founded in 1991 and structured as a private limited company (d.o.o.), the firm operates from Ljubljana with wholly-owned subsidiaries in Serbia (Novi Beograd) and Bosnia and Herzegovina (Sarajevo), serving clients in Central and Southeast Europe. The company's offerings span organization, coordination, monitoring, and regulatory support for clinical trials in Phase I–IV and bioequivalence studies, alongside medical device services including clinical investigations, clinical evaluation reports, CE marking support, and EU MDR 745/2017 technical documentation.

The underlying technology stack is services-led rather than platform-led: ADAX delivers clinical trial management, medical writing, data management, biostatistics, and functional service providing (insourcing/outsourcing of qualified experts for engagements ranging from one week to several years). Its proprietary assets are concentrated in regulatory-recognized intellectual property — notably ICH E6(R2) GCP training that meets TransCelerate BioPharma minimum criteria for mutual recognition, plus EU MDR 745/2017 training content delivered through a self-service eLearning portal at 80 EUR per course. Certificates are valid for three years and recognized by all TransCelerate member sponsors, providing a defensible credentialing asset.

ADAX generates revenue through three streams: (1) professional services fees for clinical research and medical device regulatory work sold via direct engagement to pharma and device manufacturers; (2) Functional Service Providing / staff augmentation billed on a project or duration basis; and (3) training and certification revenue through the eLearning portal (pay-as-you-go at 80 EUR per course with corporate discounts for multi-user packages). The go-to-market model is hybrid — direct sales for enterprise CRO engagements and a product-led self-service motion for individual training — supported by website content, direct email, and the eLearning portal as the primary acquisition channels.

Name

ADAX INTERNATIONAL, d.o.o.

Legal name

ADAX, raziskave v medicini, d.o.o.

Website

https://adax.si

Company type

Private

Founded year

1991

Operating status

Operating

Headcount range

1–10 employees

Short description

ADAX International is a Slovenia-based clinical research organization (CRO) serving pharmaceutical and medical device companies across Central and Southeast Europe with clinical trial monitoring, EU MDR regulatory support, and TransCelerate-recognized GCP training delivered via its eLearning portal.

Ownership category

akta.pro rank

Product category

Contract Research Organization Services

NAICS

Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Clinical Research Support (CRC/CTA) (EDAOAJAO)

Keywords

• Clinical research services
• Clinical trial management
• Medical device regulatory
• GCP training programs
• Pharmaceutical CRO

Headquarters

HQ city

Ljubljana

HQ country

Slovenia

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Clinical Research Services: Full-service clinical trial support including organization, coordination, monitoring, and regulatory affairs for pharmaceutical and medical device companies. Services span Phase I-IV clinical studies and bioequivalence studies.
2. Training and Certification: eLearning courses for GCP training and MDR regulation training, priced at 80 EUR per course. Certificates issued upon successful completion (80% pass rate, valid 3 years).
3. Functional Service Providing: Staff augmentation services providing clinical research experts for durations ranging from one week to several years through insourcing (expert works at client location) or outsourcing (expert works at ADAX location) models.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

ADAX INTERNATIONAL is a Slovenia-based clinical research organization (CRO) that delivers full-spectrum clinical trials services across Phases I–IV and bioequivalence studies, alongside medical device regulatory services covering CE marking, clinical evaluation, and technical documentation. The firm also provides functional service providing (expert staffing), medical writing, and accredited eLearning/GCP and EU MDR training courses for pharmaceutical companies, medical device manufacturers, and clinical research sites.

Product overview

ADAX INTERNATIONAL, d.o.o. is a clinical research organization providing integrated services across clinical trials, medical device regulatory support, and professional training. The core offering consists of Clinical Trials Services for pharmaceutical products (covering phases I-IV and bioequivalence studies), Medical Device Services (including clinical investigations, clinical evaluation, and technical documentation), and a Training Centre (ADAX eLearning platform) offering ICH E6(R2) GCP training courses for investigators, site personnel, and sponsor representatives, as well as EU Medical Device Regulation 2017/745 training. Additional services include expert staffing through Functional Service Providing with Insourcing and Outsourcing models, and Medical Writing services. The company operates across Slovenia, Serbia, and Bosnia and Herzegovina.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Trials Services Full-spectrum clinical trial management across Phases I–IV, including bioequivalence studies, for pharmaceutical sponsors and CRO partners.
• Medical Device Services Regulatory and clinical support for medical device manufacturers, including CE marking, clinical evaluation, and technical documentation under EU MDR 2017/745.
• Functional Service Providing Outsourced expert staffing that places clinical research professionals into client teams to augment or run sponsor-side operations.
• Medical Writing Services Preparation of clinical and regulatory documentation, including study protocols, clinical study reports, and regulatory submission content for sponsors.
• ICH E6(R2) GCP Investigator Site Personnel Training TransCelerate-recognized GCP eLearning course for investigator site personnel, offered in Slovenian and English versions to certify site staff in Good Clinical Practice.
• ICH E6(R2) GCP Sponsor's Representatives Training TransCelerate-recognized GCP eLearning course designed for sponsor representatives responsible for trial oversight.
• EU MDR 2017/745 Training eLearning course covering compliance requirements under the EU Medical Device Regulation 2017/745, aimed at manufacturers and regulatory personnel.
• Retail Trade in Medical Devices Training eLearning course addressing regulatory requirements for retail trade and distribution of medical devices.

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• TransCelerate BioPharmacoreStrategic or Co-development PartnerTransCelerate BioPharma has developed guidelines enabling innovative drug companies to recognize and rely on GCP training meeting identified Minimum Criteria. ADAX ICH E6(R2) GCP Investigator Site Training meets all minimum criteria and is recognized by all TransCelerate members as an approved training provider. This recognition enables mutual recognition of GCP training among trial sponsors globally.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Cato SMS: Specialty CRO focused on complex clinical trials, pharmacovigilance, and regulatory services. Comparable in offering a tightly focused, expertise-driven alternative to mega-CROs in pharma and devices.
• PSI CRO: Privately held, mid-size clinical CRO covering all phases plus medical-device and rare-disease services. Comparable boutique CRO profile focused on pharma/biotech sponsors with similar service breadth.
• Medpace: Mid-size clinical CRO focused on full-service Phase I-IV trials across all major therapeutic areas. Closely comparable in therapeutic-area breadth and clinical-trial-only orientation, though at much larger scale.
• Ergomed: Clinical and pharmacovigilance CRO offering Phase I-IV trial services and FSP. Comparable as a mid-tier clinical CRO with similar service mix; provides a useful size-up benchmark for ADAX.
• Worldwide Clinical Trials: Mid-size global clinical CRO offering Phase I-IV trial management, medical device and regulatory services across multiple therapeutic areas. Directly comparable to ADAX in service breadth, though with materially larger scale and global reach.

Emerging players

• Clinipace Worldwide: Mid-market, technology-enabled clinical CRO offering full-service trial management and biostatistics. Comparable therapeutic-area breadth and operational model, though with greater tech integration and US presence.

Broad incumbents

• ICON plc: Global clinical CRO formed via PRA Health Sciences and Parexel integrations. Competes directly with ADAX for multinational trial awards while offering much broader therapeutic and geographic coverage.
• Charles River Laboratories: Large, publicly listed CRO/CDMO with extensive clinical trial, regulatory, and medical-device services. Overlaps with ADAX across clinical trials, medical-device investigations, and training but operates at vastly greater scale and global reach.
• IQVIA: World's largest clinical CRO and life-science services provider. Competes with ADAX in clinical trial operations, FSP staffing, and medical-device services; included to bracket the scale ceiling.

Regional players

• Smerud Medical Research: Nordic-based clinical CRO providing trial management, monitoring, regulatory, and biostatistics for pharma and medical devices. Closely comparable in service mix, therapeutic-area breadth, and boutique/regional scale profile.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/adax-international-d-o-o-

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ADAX INTERNATIONAL, d.o.o.