HelixLab

Central laboratory infrastructure designed for clinical research — standardized measurement, traceable sample management, and protocol-compliant reporting from study design to publication.

Quality & Security: ISO/IEC 17025 ISO 9001 ISO/IEC 27001 ISO 15189 (in progress) ICH-GCP ALCOA+

HelixLab provides end-to-end support for the laboratory components of clinical studies and research projects conducted within the Omega CRO ecosystem. The primary objective is to reduce site-to-site variability in multi-center studies and to generate decision-ready, audit-ready data.

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

Expert Laboratory Team

The scientific team consists of highly experienced researchers and PhD-level scientists specialized in central laboratory operations. All medical technologists hold internationally recognized certifications and possess extensive experience across all stages of central laboratory processes.

Unlike conventional instruction-only execution models, Omega CRO actively contributes to every phase of research together with visionary scientists.

PhD

Level Scientists

GCP

Certified Staff

16+

Analytical Platforms

9

Workflow Steps

Scope of Services

Laboratory Services
Cytogenetics & FISH
DNA/RNA Services
Genomic Analyses
Flow Cytometry
Fluorescence Microscopy
Functional & Receptor Assays
Ligand Binding Assays
Microbiology Testing
Multiplex Analysis
PK/PD Testing
Virology & Immunology
Cell Culture
Safety Testing
ELISA
Neutralizing Antibody (NAb) Assays

Why Work With HelixLab?

PhD-Level Research Team

Active communication with your project team throughout all phases of clinical research.

Medical Advisory Support

Therapeutic area expertise and scientific perspective for study design and test selection.

Global Capabilities

Expanding in molecular genetics, flow cytometry, and cell culture. Strong oncology and cell/gene therapy support.

Expert Consultancy

Scientific guidance 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 & 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 QC plans.

4

Site Preparation

Site trainings, sample collection manuals, labeling systems, pre-analytical standardization.

5

Sample Receipt & Traceability

Verification of accessioning, chain-of-custody, and storage conditions.

6

Analysis & Data Generation

Execution of planned tests, interim controls, and deviation management.

7

Data Verification & Reporting

Dual review, consistency checks, and protocol-compliant reporting formats and timelines.

8

Sponsor / CRO Integration

Data transfer (EDC/eCRF), query management, and database lock support.

9

Archiving & Audit Readiness

Documentation, audit trails, and inspection-ready archiving.

Sample Types from Home (Omega Care Integration)

Samples collected at home via Omega Care are transported to HelixLab under protocol-defined conditions and incorporated into analytical workflows.

Whole Blood (EDTA, citrate, heparin)

Hematological parameters, molecular analyses, PK/PD studies

Serum & Plasma

Clinical biochemistry, immunology, biomarker, ligand binding analyses

Dried Blood Spot (DBS)

PK studies requiring remote sampling, enhanced stability scenarios

Urine

Safety assessments, metabolite analyses, PK support

Saliva

Hormone analyses, genetic/molecular studies, non-invasive sampling

Nasal/Oropharyngeal Swabs

Virological and molecular testing

Stool Samples

Microbiome and translational research (protocol-dependent)

Need Central Lab Support?

From multi-center studies to complex biomarker programs — HelixLab delivers reliable, audit-ready data.

Contact Our Lab Team