Clinical Trials
Comprehensive support from protocol design to final study reports — covering Phase I through Phase IV across all therapeutic areas.
End-to-End Clinical Trial Management
As Turkey's first CRO, established in 1997, Omega CRO brings over 25 years of experience in managing Phase III and IV clinical trials and post-marketing surveys. Our full-service capabilities span the entire clinical development lifecycle — from initial protocol design and regulatory submissions to site management, monitoring, data analysis, and final clinical study reports.
We support biotechnology, pharmaceutical, and medical device companies in accelerating the development of their medical therapeutics through a comprehensive range of clinical research services and a collaborative approach. Our experienced team works closely with sponsors to ensure every aspect of the study is planned with precision, from initial concept through to regulatory submission.
Phase I–IV Clinical Trial Expertise
Phase I
First-in-human safety, pharmacokinetics, dose-finding in healthy volunteers or small patient cohorts.
Phase II
Proof-of-concept, efficacy signal, dose optimization, and safety in target patient populations.
Phase III
Pivotal registrational trials with large patient cohorts for efficacy and safety confirmation.
Phase IV
Post-marketing surveillance, long-term safety, real-world effectiveness, and new indications.
Comprehensive Trial Capabilities
Every aspect of your clinical trial, managed by experienced professionals under one roof.
Protocol Design & Study Planning
Scientifically rigorous protocol development, sample size calculation, endpoint selection, and statistical analysis planning aligned with regulatory requirements.
Regulatory Submissions
Comprehensive regulatory affairs support including IND/CTA preparation, ethics committee submissions, and agency communications (TİTCK, EMA, FDA).
Site Selection & Management
Global site network with experienced investigators, rapid site activation, and proactive monitoring ensuring GCP compliance and data quality.
Data Management & Biostatistics
Integrated data management, electronic data capture (EDC), statistical analysis, and medical writing for clinical study reports (CSR).
Safety & Pharmacovigilance
Dedicated safety monitoring, SAE management, periodic safety reports, and risk-based quality management throughout the trial.
IMP Supply & Logistics
Turkey's first clinical trial-specific depot (est. 2003) with secure import, storage, distribution, and destruction of investigational products.
Why Turkey for Clinical Trials?
Turkey offers a strategic advantage for conducting clinical trials due to its well-established regulatory framework, experienced investigators, diverse patient population, and cost-effective site operations. Omega CRO's direct presence in Türkiye, TRNC, USA, and Kosovo — with partnerships across the EU and MENA — ensures efficient enrollment and high-quality data across multi-regional studies.
Application Scenarios in the Omega Ecosystem
How the Omega Research Ecosystem supports clinical trials with integrated laboratory, home-based, and diagnostic solutions.
Omega Care
In-Home Patient Visits
Turkey's first dedicated in-home clinical trial visit service (est. 2019). Protocol-compliant home sampling, PRO collection, and follow-up that reduce site burden and improve patient retention.
Omega Genetics
Biomarker-Driven Patient Stratification
Pharmacogenomic profiling, companion diagnostic testing, and molecular biomarker analysis for patient selection and response monitoring in precision medicine trials.
HelixLab
Central Safety Laboratory
Protocol-aligned safety panels (hematology, biochemistry, coagulation, urinalysis) with standardized pre-analytical workflows across all study sites. ISO 17025 accredited.
Omega Bio
Companion Diagnostic Kits
Kit-based assay standardization for biomarker and immunogenicity testing, ensuring lot-to-lot consistency across multi-country trials.
Omega Biorepository
Longitudinal Sample Biobanking
Multi-temperature biobanking of serial serum, plasma, and tissue samples enabling retrospective biomarker analysis and future-proofing trial data.
Animal Facility
Preclinical-to-Clinical Transition
GLP-compliant toxicology, pharmacology, and safety studies to support IND-enabling packages before first-in-human dosing.
Ready to Start Your Clinical Trial?
Partner with Turkey's first CRO for comprehensive, end-to-end clinical trial management.
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