Omega CRO

What Omega CRO does

Omega CRO, founded in March 1997 in Ankara, Turkey, is the country's first Contract Research Organization and operates as a privately held, full-service CRO serving biotechnology, pharmaceutical, and medical device companies. The company executes Phase I-IV clinical trials, post-marketing studies, observational research, and pharmacoeconomic studies, with documented throughput of more than 1,000 medium-to-large projects cumulatively, 50+ mid-large projects per year, and 400+ investigator-initiated trials supported annually. It has built an integrated ecosystem of nine in-house capabilities: full-service clinical operations, HelixLab central laboratory, Omega Genetics laboratory, Omega Biorepository, Omega Depot for Investigational Medicinal Product logistics, OmegaCare home healthcare, TURP remote patient monitoring and digital health platform, Randomizasyon.com.tr IWRS, and GlobaSteer data science and analytics.

The technology backbone centers on TURP, a digital health platform that integrates certified medical devices (pulse oximeters, ECG, Holter monitors, CGMs, ultrasound, digital stethoscopes) with clinician dashboards, structured patient monitoring, and messaging, supporting decentralized trial execution. HelixLab provides standardized central lab analyses with traceable sample management under ISO 9001, ISO/IEC 27001, ALCOA+, and GCLP frameworks, while Omega Biorepository maintains multi-temperature-zone storage with chain-of-custody controls aligned to CAP and ISBER guidelines. GlobaSteer delivers AI/ML-enabled predictive analytics, risk-based monitoring, and biometrics services. Compliance posture spans ICH-GCP, GDPR, KVKK, FDA/CE-certified medical device integrations, and Turkish regulatory (TITCK) expertise.

Omega CRO generates revenue through professional services fees for clinical research management, with an enterprise field sales go-to-market targeting pharmaceutical, biotech, and medical device sponsors. Pricing is custom-quoted per study with no public disclosure. Operations span six countries with direct teams (Turkey, Azerbaijan, Turkish Republic of Northern Cyprus, USA, Canada, Kosovo) and a partner network extending reach across the EU and MENA region through EUCROF membership. The company maintains sub-5% employee turnover among its 200+ full-time workforce and is recognized among Turkey's Top 500 service exporters.

Name

Omega CRO

Legal name

OMEGA CRO

Website

https://omega-cro.com.tr

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

51–100 employees

Short description

Omega CRO is Turkey's first Contract Research Organization (founded 1997), providing full-service Phase I-IV clinical research management to pharmaceutical, biotechnology, and medical device companies across six countries. Its integrated ecosystem spans a central lab, genetics lab, biorepository, IMP depot, home healthcare, and the TURP remote patient monitoring platform.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Medical and Diagnostic Laboratories (6215), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE), Real-World Evidence (RWE), HEOR & Epidemiology CROs (HLAGAAAK), Bioanalytical & Biomarker CROs (PK/PD/Immunogenicity) (HLAGAAAD), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

Keywords

• Clinical research services
• Contract research organization
• Clinical trial management
• Pharmaceutical research management
• Central laboratory services

Headquarters

HQ city

Beytepe

Offices6 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: Full-service CRO providing clinical and epidemiological research management to pharmaceutical companies, biotechnology companies, and medical device organizations. Services span Phase I-IV clinical trials and post-marketing studies. Revenue is generated through service fees for study design, execution, monitoring, data management, regulatory affairs, and other research management services.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

Omega CRO is a full-service Contract Research Organization providing end-to-end clinical research management for biotechnology, pharmaceutical, and medical device companies. Services span Phase I-IV clinical trials and post-marketing studies, including clinical strategy and design, regulatory affairs, project and quality management, clinical operations, data science and biometrics, safety and pharmacovigilance, clinical supply and logistics, and patient-centered/decentralized trial solutions. The offering is delivered through an integrated in-house ecosystem that combines proprietary digital health technology (TURP), an IWRS platform (Randomizasyon.com.tr), central laboratory and biorepository services (HelixLab, Omega Genetics, Omega Biorepository), home healthcare (OmegaCare), IMP depot logistics, and AI-driven analytics (GlobaSteer).

Product overview

Omega CRO is Turkey's first Contract Research Organization (established 1997) offering a comprehensive, integrated clinical research ecosystem. The portfolio centers on full-service CRO capabilities (clinical strategy, regulatory affairs, data management, safety) enhanced by proprietary digital health technology (TURP Remote Patient Monitoring platform) and a unified laboratory infrastructure (HelixLab, Omega Genetics, Omega Biorepository, Laboratory Animal Facility). Operational services include OmegaCare home healthcare, Omega Depot for IMP logistics, and specialized patient engagement platforms (calismasi.info, arastirmasi.info). The GlobaSteer subsidiary provides AI-powered data science. The ecosystem integrates therapeutic expertise across cardiovascular, dermatology, endocrinology/metabolic, gastroenterology, and hemophilia. Financial management is supported through Omega Pay, and randomization through Randomizasyon.com.tr.

Differentiator

Problem solved

Functional benefit

Products and services

• Full-Service Clinical Research (CRO) Services End-to-end clinical research management for biotechnology, pharmaceutical, and medical device sponsors, covering Phase I-IV trials and post-marketing studies, including clinical strategy and design, regulatory affairs, project and quality management, clinical operations, data science and biometrics, safety and pharmacovigilance, clinical supply and logistics, and patient-centered/decentralized solutions.
• TURP Remote Patient Monitoring and Digital Health Platform Digital health platform that enables healthcare professionals to monitor patients remotely during clinical trials, providing structured patient follow-up programs, centralized measurement management, medical device integration (pulse oximeters, ECG, Holter, CGM, smart rings, etc.), clinician dashboard for patient lists and messaging, and AI-supported decision features.
• HelixLab Central Laboratory Central laboratory service for clinical research providing standardized measurement approaches, traceable sample management, and protocol-compliant reporting. Capabilities include molecular genetics, flow cytometry, cell culture, PK/PD, and immunogenicity assessments, staffed by a PhD-level research team under ISO 9001 and ISO/IEC 27001.
• Omega Genetics Laboratory Genomic and molecular analysis laboratory providing biomarker and pharmacogenomic testing, NGS validation, and bioinformatics support for clinical trial design and patient stratification.
• Omega Biorepository Secure, traceable storage infrastructure for biological specimens across multiple temperature zones (room temperature, +4°C, -20°C, -70°C/-80°C, and cryogenic liquid nitrogen), with chain-of-custody management and audit readiness compliant with CAP and ISBER guidelines.
• Laboratory Animal Facility Preclinical research facility providing ethical and regulatory-compliant housing, monitoring, and study support for laboratory animals, compliant with EU Directive 2010/63/EU, GLP principles, and local HADYEK ethics committee approvals.
• OmegaCare Home Healthcare Licensed home healthcare service providing decentralized clinical trial support through protocol-compliant home visits, sample collection, patient monitoring, and follow-up services for decentralized and hybrid clinical trials.
• GlobaSteer Data Science Platform Dedicated data science subsidiary providing advanced analytics using AI and machine learning technologies, plus risk-based monitoring (RBM) and predictive analytics to support clinical trial decision-making.
• Real-World Evidence (RWE) Generation Comprehensive RWE solutions that leverage real-world data to provide insights into the safety, efficacy, and value of medical interventions in routine clinical practice, including observational studies and registries.
• Omega Depot (IMP Storage and Distribution) Licensed depot facility for secure storage and distribution of Investigational Medicinal Products (IMPs) and Non-Investigational Medicinal Products (NIMPs) for clinical trials.
• Randomizasyon.com.tr IWRS Platform Interactive Web Response System (IWRS) platform providing randomization and product management solutions for clinical trial operations, maintained in compliance with international regulations.
• Patient Recruitment Platforms (calismasi.info and arastirmasi.info) Targeted promotional websites for patient recruitment in clinical trials, enabling creation of personalized study websites to boost visibility and engagement among potential clinical trial participants.
• Cardiovascular Observational Research Services Specialized cardiovascular observational research capabilities including national registries (TURKMI, PatenT, HinT, HAPPY, SALTURK, Cappadocia Cohort) and real-world evidence generation for cardiovascular therapies.
• Hemophilia Clinical Trial Support Specialized laboratory and clinical support for hemophilia studies including coagulation testing, inhibitor monitoring, PK/PD sampling, genetic analysis, and home sampling coordination.

Quantifiable outcome

• 1,000+ medium-large-scale research projects completed across nearly 30 years of operation
• +3 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature7 records

Partnerships

Four partnerships are on record, tiered core.

• EUCROF (European CRO Federation)coreStrategic or Co-development PartnerOmega CRO is a collaborating partner with the European CRO Federation (EUCROF), providing direct access to a vast network of European research expertise, ensuring alignment with the latest EU regulations, and enhancing ability to conduct efficient and compliant observational studies across the European Union.
• Trusted CRO Partners (USA & Canada)coreChannel Partner/ Reseller/ DistributorStrategic alliances with leading CROs in the United States to navigate the complex FDA regulatory landscape and manage US-based sites effectively. Through trusted CRO partners in both USA and Canada, Omega provides full support for studies requiring Health Canada approvals, complementing direct US operations for comprehensive North American coverage.
• Trusted CRO Partners (EU)coreChannel Partner/ Reseller/ DistributorCollaborations with respected CRO partners across key EU member states allow Omega CRO to manage multi-country studies efficiently, ensuring compliance with EMA and national regulations across the European Union.
• Regional CRO Partners (MENA)coreChannel Partner/ Reseller/ DistributorStrong, reliable partnerships with regional CROs across the Middle East and North Africa (MENA) providing in-depth understanding of local ethics committees, regulatory bodies, and healthcare practices, enabling successful study execution and patient recruitment in diverse MENA markets.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• IQVIA: The largest global CRO and real-world evidence provider, offering full-service Phase I–IV clinical operations, central labs, and data analytics. Comparable to Omega CRO as the dominant scale incumbent across the same sponsor base and service categories.
• ICON plc: Top-three global full-service CRO with broad therapeutic-area coverage and central laboratory services. Comparable to Omega CRO across full-service clinical operations, central lab, and post-PRA Health Sciences integration scope.
• Parexel International: Major global full-service CRO (taken private by EQT/Goldman Sachs) with deep Phase II–IV and post-marketing capability. Comparable to Omega CRO on full-service CRO positioning and therapeutic-area expertise.
• Charles River Laboratories: Global CRO spanning preclinical through clinical research, including a Discovery and Safety Assessment segment. Comparable to Omega CRO's clinical operations, safety/pharmacovigilance, and preclinical lab services footprint.
• Fortrea Holdings: Clinical development and patient access business spun off from Labcorp in 2023, offering full-service Phase I–IV CRO and post-approval services. Comparable to Omega CRO as a full-service clinical research competitor.

Direct peers

• Medpace Holdings: Mid-size, profitable, full-service CRO with strong central lab, biometrics, and image-management capabilities. Most directly comparable to Omega CRO as a full-service clinical CRO competing for similar mid-sized biotech and pharma sponsors.
• Worldwide Clinical Trials: Mid-size full-service CRO with therapeutic expertise in CNS, cardiometabolic, oncology, and rare diseases. Comparable to Omega CRO on mid-size full-service model and specialty therapeutic depth.
• CTI Clinical Trial & Consulting Services: Mid-size full-service CRO with therapeutic specialization in rare/orphan diseases, hematology, and infectious disease. Comparable to Omega CRO on mid-size CRO model and specialty therapeutic positioning (e.g., hemophilia).

Emerging players

• Novotech: Asia-Pacific focused full-service CRO (backed by private equity) expanding globally in biotech Phase I–III trials. Comparable to Omega CRO as a regionally-rooted, fast-growing full-service CRO targeting biotech sponsors.

Regional players

• KCR: European-headquartered (Poland) full-service CRO with strong Central/Eastern Europe presence and Phase I–IV coverage. Comparable to Omega CRO as a regional European-rooted full-service CRO with overlapping emerging-market geographies.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/omega-contract-research-organization-cro-

Compliance15 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries9 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 Omega CRO