CLINMARK

What CLINMARK does

CLINMARK sp. z o.o. is a privately held, founder-owned Contract Research Organization (CRO) headquartered in Warsaw, Poland, founded in 2001 and operating continuously for 23 years. The company provides a full-service clinical research portfolio — including clinical trial execution across phases I-IV, project management, regulatory affairs, clinical monitoring, medical monitoring, data management, biostatistics, pharmacovigilance, and medical writing — to pharmaceutical, biotechnology, and medical device sponsors across 75+ countries on five continents, with a documented specialization in emerging markets (Africa, Eastern Europe, Middle East, Asia) since 2005.

Beyond core CRO delivery, CLINMARK operates three adjacency lines: (i) a CDMO segment covering comparator sourcing from ~60 markets, placebo development, secondary labeling and packaging, and cold-chain pharmaceutical logistics spanning -78.5°C to +25°C; (ii) a quality/consulting practice delivering GCP and GMP audits, mock regulatory inspections, due diligence, and Quality Management System advisory; and (iii) specialized services including Project Rescue (advertised 3-week average regulatory submission turnaround), Functional Service Provision (FSP), patient recruitment, and dedicated Medical Device (CE Mark/FDA/MDR), cosmetics, and dietary supplement offerings. The company claims 8 of the top 10 pharmaceutical companies as clients, 400+ clinical trials and 450+ consulting engagements executed, 25,000+ subjects enrolled, and audits performed across 60+ GMP geographies.

The business model is enterprise professional services on a project/quote-based pricing model with no public pricing, sold through direct field sales and event-driven demand generation (BIO-Europe, OCT Barcelona, CEBioForum, Clinical Trials for Medical Device Conference). The revenue mix is roughly evenly split across clinical trial execution, consulting, FSP staffing, and CDMO services. Distribution is single-channel (direct enterprise sales) to mid-to-large pharma/biotech sponsors. The company is privately held, has no disclosed institutional investors, no funding rounds, and no subsidiaries; ownership is concentrated in CEO Marek Wasiluk (DMD, MBA; in clinical trials since 1999) and CSO Grzegorz Pogorzelski, MD (former VP/Head of Clinical Operations at international CROs and prior tenure at Merck & Co.).

Name

CLINMARK

Legal name

Clinmark sp. z o.o.

Website

https://clinmark.eu

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

11–50 employees

Short description

CLINMARK is a Warsaw-based full-service Contract Research Organization founded in 2001, serving pharmaceutical, biotechnology, and medical device companies globally with clinical trial execution, consulting, and CDMO services across 75+ countries, including emerging markets.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

Keywords

• Clinical research services
• Contract research organization
• Pharmacovigilance services
• Medical device regulatory
• GCP compliance audits

Headquarters

HQ city

Warsaw

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: Full-service clinical trial execution including project management, clinical monitoring, data management, biostatistics, medical monitoring, pharmacovigilance, and medical writing services for pharmaceutical and biotechnology companies
2. Consulting Services: Quality management consulting, study planning, vendor selection, project oversight, risk assessment, due diligence evaluations, and regulatory inspection preparation services
3. Functional Service Provision (FSP): Flexible staffing and functional service provision allowing sponsors to augment their teams with Clinmark experts on an as-needed basis
4. Pharmaceutical Logistics: Distribution services for IMPs, RLDs, lab kits, medical devices including cold chain transport, comparator sourcing, placebo manufacturing, labeling and packaging

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

CLINMARK is a full-service Contract Research Organization (CRO) providing clinical trial execution, regulatory affairs, data management, biostatistics, pharmacovigilance, medical writing, and project management services to pharmaceutical, biotechnology, and medical device companies. The company also offers consulting services including GCP/GMP audits, mock inspections, due diligence, QMS consultancy, and a CDMO segment covering comparator sourcing, placebo development, labeling/packaging, and pharmaceutical distribution across 75+ countries.

Product overview

CLINMARK is a full-service Contract Research Organization (CRO) established in 2001, offering an integrated portfolio of clinical research and consulting services. The core offering includes clinical trials execution across phases I-IV with supporting operational services (Project Management, Data Management, Biostatistics, Medical Monitoring, Pharmacovigilance, Medical Writing, and Clinical Monitoring). Specialized divisions cover Medical Devices (CE Mark, FDA Registration, clinical investigations), cosmetics testing, and dietary supplements services. The CDMO segment provides manufacturing-related services including Comparator Sourcing, Placebo Development, Labeling and Packaging, and Distribution. Consulting services encompass GCP/GMP Audits, Mock Inspections, Due Diligence, and QMS Consultancy. The company also offers Project Rescue Services and Functional Service Provision (FSP). This combination of operational, manufacturing, and consulting services creates an integrated ecosystem for pharmaceutical and biotech company drug development needs.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Trials Execution Full-service clinical trial management from protocol design through study completion, covering patient enrollment, site management, and operational execution across phases I-IV for pharmaceutical and biotechnology sponsors.
• Regulatory Affairs

Quantifiable outcome

• 25,000+ enrolled subjects
• +3 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Three partnerships are on record, tiered notable and strategic.

• PolTREG S.A.notableStrategic or Co-development Partner · 1 July 2023Clinmark cooperates with PolTREG team working on drugs for innovative cell and gene therapies for autoimmune diseases. Clinmark team participated in the opening of PolTREG's state-of-the-art cell and gene therapy manufacturing facility, described as one of the most modern plants in Europe.
• University of NgaounderestrategicStrategic or Co-development Partner · 1 January 2020Partnership agreement established with University of Ngaoundere in Cameroon under the auspices of the Prime Minister of Cameroon for cooperation in organizing pre-clinical studies, sharing knowledge and best practices for clinical trials development, and effective market authorization of new products.
• Brain Research Africa InitiativestrategicStrategic or Co-development Partner · 1 January 2020Partnership with Brain Research Africa Initiative leaders to establish cooperation framework for medicinal product development and clinical trials in Africa.

Scale indicators17 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• IQVIA: IQVIA is the world's largest CRO and clinical technology provider, offering full-service Phase I–IV clinical trial execution, consulting, and real-world evidence services to top-10 pharma. Directly comparable to Clinmark's core CRO offering but at vastly greater scale and with proprietary technology platforms.
• Parexel International: Parexel is a large global CRO offering Phase I–IV clinical development, regulatory consulting, and biopharmaceutical services. Directly competes with Clinmark for enterprise pharma trial mandates across multiple therapeutic areas.
• Charles River Laboratories: Charles River is a large CRO/research services provider with a broad preclinical and clinical footprint, including biostatistics, pharmacovigilance, and consulting. Overlaps with Clinmark's clinical and consulting service lines but is materially larger and more diversified.
• ICON plc: ICON is a top-3 global CRO providing full-service clinical development, consulting, and laboratory services to pharmaceutical and biotech sponsors. Comparable to Clinmark across Phase I–IV trials, biostatistics, and pharmacovigilance but with materially greater headcount and geographic infrastructure.

Direct peers

• Medpace: Medpace is a mid-to-large full-service CRO with strong therapeutic specialization (including oncology) and a reputation for high-quality execution, similar to Clinmark's positioning. Comparable business model — scientific-led, sponsor-focused — and competes head-to-head for biotech and emerging pharma trials.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized CRO focused on Phase II–IV trials, pharmacovigilance, and consulting across multiple therapeutic areas including oncology and CNS. Closely comparable to Clinmark in size, service breadth, and therapeutic focus.
• Pharm-Olam International: Pharm-Olam is a mid-sized full-service CRO with deep emerging-markets reach (Latin America, Eastern Europe, Middle East, Africa), mirroring Clinmark's geographic niche. Competes directly for sponsor trials routed through emerging regions.
• Advanced Clinical: Advanced Clinical is a mid-sized CRO and consulting firm serving pharma, biotech, and medical device sponsors with clinical operations and quality/GCP consulting. Overlaps directly with Clinmark's CRO plus consulting bundle.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/clinmark
• Facebookfacebook.com/profile.php

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 CLINMARK