HelixLab | Omega CRO Central Laboratory

Comprehensive central laboratory support delivered with scientific accuracy, regulatory compliance, and operational excellence, spanning from clinical research to advanced R&D programs.

Introduction 

HelixLab provides end-to-end support for the laboratory components of clinical studies and research projects conducted within the Omega CRO ecosystem through standardized measurement approaches, traceable sample management, and protocol-compliant reporting principles. The primary objective is to reduce site-to-site variability in multi-center studies and to generate decision-ready, audit-ready data.

Laboratory, analytical, and operational services provided within the Omega ecosystem are delivered through Omega’s internal units or authorized partner infrastructures that comply with applicable standards, depending on the nature of the study, regulatory requirements, and methodological scope. Accreditations, certifications, and official authorizations apply at the level of the unit or partner organization where the service is actually performed and are assessed on a study-specific basis for each service category.

Our Services

The scope of HelixLab includes safety and supportive laboratory needs in clinical research, as well as specialized analytical platforms used in advanced R&D programs.

Full-Service Central Laboratory Support

For safety and supportive laboratory needs in clinical research, HelixLab delivers end-to-end central laboratory services focused on standardized measurement approaches, protocol-compliant reporting, and structured data transfer.

Expert Laboratory Team

The scientific team of the Omega CRO Central Laboratory consists of highly experienced researchers and PhD-level scientists specialized in central laboratory operations. This structure ensures that each project is supported by high-accuracy data generation and reliable analytical outcomes. All medical technologists within the Omega CRO Central Laboratory hold internationally recognized certifications in their respective fields and possess extensive experience across all stages of central laboratory processes, including sample processing, analysis execution, data verification, and reporting. Unlike conventional instruction-only execution models, Omega CRO actively contributes to every phase of research together with visionary scientists, continuously supporting the strategic planning and optimal execution of your study. The Omega CRO Central Laboratory is led by PhD-level scientists specialized in laboratory methodologies and assay development. From project initiation onward, our expert team works in close collaboration with research teams, providing scientific consultancy on study design, laboratory method selection, biomarker strategy, and technology transfer processes.

     Scope 

  • Laboratory Services
  • Cytogenetics and Fluorescence In Situ Hybridization (FISH) Analyses
  • Deoxyribonucleic Acid (DNA) / Ribonucleic Acid (RNA) Services
  • Genomic Analyses
  • Flow Cytometry
  • Fluorescence Microscopy
  • Functional and Receptor Assays
  • Ligand Binding Assays
  • Microbiology Testing
  • Multiplex Analysis Platforms
  • Pharmacokinetic (PK) / Pharmacodynamic (PD) Testing
  • Virology and Immunology Analyses
  • Cell Culture
  • Safety Testing
  • Enzyme-Linked Immunosorbent Assay (ELISA)
  • Neutralizing Antibody (NAb) Assays

Advantages of Working with the Omega CRO Central Laboratory

  • A PhD-level research team maintaining active communication with your project team throughout all phases of clinical research
  • Medical advisory support providing therapeutic area expertise and scientific perspective
  • Expanding global capabilities in molecular genetics, flow cytometry, and cell culture, with strong support for oncology and cell and gene therapy-focused research
  • Expert guidance and scientific consultancy in study design, test selection, and method validation

Operational Workflow

  1. Study initiation: laboratory-focused review of protocol, endpoints, and biomarker requirements
  2. Test selection and methodological strategy: definition of test panels based on analyte, platform, cut-off values, and sample matrix
  3. Method validation / verification: establishment of feasibility, performance characteristics, and Quality Control (QC) plans
  4. Site preparation: site trainings, sample collection manuals, labeling systems, and pre-analytical standardization
  5. Sample receipt and traceability: verification of accessioning, chain-of-custody, and storage conditions
  6. Analysis and data generation: execution of planned tests, interim controls, and deviation management
  7. Data verification and reporting: dual review, consistency checks, and protocol-compliant reporting formats and timelines
  8. Sponsor/CRO integration: data transfer (e.g., EDC/eCRF integrations), query management, and database lock support
  9. Archiving and audit readiness: documentation, audit trails, and inspection-ready archiving

HelixLab operations are planned in alignment with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) principles, data integrity requirements (ALCOA+), audit readiness, and traceable sample management through chain-of-custody approaches.

  • All laboratory processes are conducted based on ISO/IEC 17025 requirements, with a focus on analytical consistency, accuracy, and quality assurance
  • The Omega CRO Central Laboratory holds ISO 9001 and ISO/IEC 27001 certifications for quality management and information security
  • Formal assessment processes are ongoing for internationally recognized ISO/IEC 17025 and ISO 15189 laboratory accreditations
  • Documentation and audit trail coverage throughout the full sample lifecycle (collection, transport, receipt, processing, storage, analysis, and reporting)
  • Chain-of-custody principles supporting correct sample collection, transport, and handling under appropriate conditions
  • Protocol-compliant reporting, data transfer formats, and timelines aligned with sponsor/CRO requirements
  •  
  • Multi-center clinical studies requiring measurement standardization and reduction of site-to-site variability
  • Studies involving complex biomarker and cellular analyses, such as oncology and cell and gene therapy programs
  • Development programs where Pharmacokinetic (PK), Pharmacodynamic (PD), and immunogenicity assessments are critical
  • Projects requiring high sample volumes, short reporting timelines, and frequent interim data transfers
  • Studies conducted under intensive audit conditions and international sponsor standards

Sample Types That Can Be Collected at Home and Analyzed at HelixLab

  • Whole blood (EDTA, citrate, heparin): hematological parameters, molecular analyses, PK/PD studies
  • Serum and plasma: clinical biochemistry, immunology, biomarker, and ligand binding analyses
  • Dried blood spot (DBS): PK studies requiring remote sampling and scenarios benefiting from enhanced stability
  • Urine: safety assessments, metabolite analyses, and PK support
  • Saliva: hormone analyses, genetic/molecular studies, and protocols requiring non-invasive sampling
  • Nasal/oropharyngeal swabs: virological and molecular testing (general scope)
  • Stool samples: microbiome and translational research (protocol-dependent)

Transport, Receipt, and Analysis Processes

Samples collected at home are transported to the HelixLab central laboratory in accordance with protocol-defined transport conditions. Upon receipt, sample integrity, labeling compliance, and transport records are verified. Samples meeting acceptance criteria are incorporated into predefined analytical workflows.

All data generated during analytical processes are recorded in compliance with ALCOA+ principles and reported in formats compatible with sponsor/CRO data management systems.

Through this structured approach, home sampling is transformed from a potentially high-risk operation into an auditable and sustainable component of clinical research.