Omega Research Ecosystem

Omega Research Ecosystem

An integrated data approach in clinical research — from study design to analysis, and from analysis to publication.

The Challenge

What Problems Do We Solve?

In multi-center clinical studies, data consistency, traceability, and scientific quality are critical elements that affect the entire research lifecycle. These factors extend beyond the analysis phase and influence study design, sampling strategies, the selection of diagnostic kits, statistical evaluation approaches, clinical trial monitoring, and the transformation of results into scientific outputs.

The Omega Research Ecosystem delivers integrated solutions aimed at generating globally comparable and reliable data — through a combination of central laboratory infrastructure, kit-based and validated analysis platforms, clinical research-ready methodologies, protocol-aligned statistical analysis frameworks, and continuous scientific and methodological oversight throughout the study lifecycle.

The Omega Research Ecosystem

Six integrated units working under a unified operational plan to deliver end-to-end research support — from home-based patient care to advanced molecular diagnostics.

Omega Care

Home Health

Clinical trial home visits — protocol-compliant home sampling, dosing, and follow-up solutions that reduce site burden. Securely integrates off-site data generation while maintaining visit windows, sample quality, and traceability.

Clinical Trial Home Visits ICH GCP ALCOA+
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Omega Genetics

Omega Genetics

Integrated biomarker and pharmacogenomic approaches within genomic and molecular analyses. Validated methods, NGS, WGS/WES, liquid biopsy, and bioinformatics support translating genetic data into clinically meaningful outcomes.

NGS / WGS GCLP Bioinformatics
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HelixLab

HelixLab

Central laboratory infrastructure designed for clinical research. Standardized measurement, protocol-aligned methodology, and a robust quality framework from study design to reporting.

ISO/IEC 17025 ISO 9001 ISO 27001
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Omega Bio

Omega Bio

Kit-based analytical infrastructure enabling methodological standardization and alignment for selected molecular techniques, depending on protocol requirements. Integrates with HelixLab workflows for diagnostic kit validation.

Kit-Based Standardization

Omega Biorepository

Complete biological specimen lifecycle management — from collection to long-term storage with chain-of-custody traceability. Multi-temperature zones from ambient to cryogenic LN₂ with ISBER-aligned operations.

ISBER GCLP CAP LN₂
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Omega Drug Depot

Türkiye’s first clinical trial depot since 2003 — IMP storage, temperature-controlled distribution, import licence and customs.

2003 2-8°C -25°C 7/24
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Laboratory Animal Facility

Ethical, regulation-compliant preclinical animal studies. HADYEK-approved, 3R principles, EU Directive 2010/63/EU aligned. Toxicology, pharmacology, and safety data generation prior to clinical transition.

GLP HADYEK 3R Principles
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Analytical Service Domains

The ecosystem's analytical services span the full spectrum from safety laboratory to advanced molecular and cellular testing.

Safety Lab

Hematology, biochemistry, coagulation, urinalysis

Genomic & Molecular

NGS, WGS, WES, Sanger sequencing, MLPA, fragment analysis

Microbiology

Culture-based methods, PCR, qPCR, antimicrobial susceptibility

Viral Safety & Virology

Viral load testing, serology, neutralization assays

Flow Cytometry

Immunophenotyping, cell enumeration, receptor analysis

Cytogenetics & FISH

Chromosomal analysis, fluorescence in situ hybridization

Biomarker Development

Biomarker discovery, assay development, method validation

PK/PD Testing

Pharmacokinetic / pharmacodynamic bioanalysis

Immunogenicity

ELISA, NAb assays, immunogenicity assessment

Cell Culture

PBMC preparation, cell counting, viability analysis

Ligand Binding Assays

Receptor binding, functional cell-based assays

Diagnostic Kits

Kit-based analysis infrastructure (Omega Bio)

Scientific Leadership & Quality Approach

Ecosystem activities are managed in an integrated manner under a Scientific & Laboratory Directorate structure. This model is designed to ensure continuity of quality systems and preservation of methodological integrity.

Biorepository operations are structured in alignment with GCLP (Good Clinical Laboratory Practice), CAP (College of American Pathologists), and ISBER (International Society for Biological and Environmental Repositories) guidelines.

GCLP CAP ISBER ICH-GCP ALCOA+

Quick Ecosystem Scope Definition

To quickly define the ecosystem scope for your study, sharing the following information is sufficient:

  • 1. Therapeutic area / indication
  • 2. Study phase and design summary
  • 3. Sample types and visit windows
  • 4. Required analytical domains
  • 5. Reporting format and data transfer expectations
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