Laboratory Animal Facility
Introduction and Scope
The Laboratory Animal Facility operating within the Omega CRO and HelixLab ecosystem provides the ethical, scientific, and regulatory-compliant housing, monitoring, and inclusion of laboratory animals used in preclinical research. This infrastructure is designed to support the generation of safety, pharmacology, and toxicology data prior to transition into clinical research.
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.
Regulatory and Ethical Framework
All activities involving laboratory animals are conducted in full compliance with national and international ethical and regulatory requirements. Animal welfare and scientific integrity are addressed in parallel.
- Approval by the Local Ethics Committee for Animal Experiments (HADYEK).
- Application of the 3R principles: Replacement, Reduction, and Refinement.
- Alignment with European Union Directive 2010/63/EU.
- Adherence to Good Laboratory Practice (GLP) principles.
Animal Species and Housing Infrastructure
The Laboratory Animal Facility is equipped with infrastructure suitable for housing different laboratory animal species according to study-specific requirements.
- Small laboratory animals, primarily guinea pigs.
- Species- and age-appropriate caging and environmental enrichment.
- Controlled temperature, humidity, and lighting conditions.
- Biosafety measures and cross-contamination prevention.
Animal Welfare and Daily Monitoring
Animal welfare forms the foundation of all laboratory animal studies. Daily monitoring and documentation systems ensure continuous assessment of animal health and behavior.
- Daily clinical observation and health checks.
- Body weight monitoring and general condition assessment.
- Early detection of stress and pain indicators.
- Veterinary supervision and intervention protocols.
Experimental procedures are conducted by qualified personnel in accordance with approved protocols. The primary objective is to maintain scientific data quality while minimizing the burden on animals.
- Dose administration (oral, parenteral, etc.).
- Blood and biological sample collection.
- Behavioral and physiological observations.
- Anesthesia and analgesia applications.
The laboratory animal facility supports the generation of safety and toxicology data prior to the transition into clinical research.
- Acute and subchronic toxicity assessments.
- Dose–response and tolerability studies.
- Target organ toxicity observations.
- Preliminary pharmacodynamic and pharmacokinetic evaluations.
Biological samples obtained from laboratory animals are processed and analyzed in an integrated manner with the HelixLab central laboratory infrastructure.
- Traceable collection of blood, tissue, and other biological samples.
- Sample management using a chain-of-custody approach.
- Integration with biochemistry, hematology, and histopathology analyses.
All laboratory animal studies are documented using traceable and auditable documentation practices.
- Raw data and observational records.
- Documentation of protocol and procedural deviations.
- Archiving systems prepared for audits and inspections.
Integration within the Omega Ecosystem
The Laboratory Animal Facility operates in an integrated manner with other units within the Omega CRO ecosystem to provide end-to-end research support.
- HelixLab: central analytical and laboratory integration.
- Omega Genetics: genetic and molecular assessments.
- Omega Biorepository: long-term storage of biological samples.
Preclinical to Clinical Continuum
Continuity between preclinical and clinical research phases is critical for scientific accuracy, patient safety, and operational efficiency in drug and biological product development. The Omega CRO ecosystem addresses this continuity through an integrated and traceable framework extending from early-phase findings to clinical decision points.
This continuum approach aims to transfer data generated in preclinical studies not merely as background information, but as decision-supporting and guiding evidence for clinical research.
Studies conducted within the Laboratory Animal Facility establish the scientific foundation for transition into clinical phases with respect to safety, tolerability, pharmacology, and toxicology.
- Evaluation of dose–response relationships.
- Monitoring of target organ toxicity and early safety signals.
- Identification of biomarker candidates applicable to clinical studies.
Biological samples and measurements obtained from preclinical studies are evaluated in an integrated manner with the HelixLab central laboratory infrastructure, enhancing comparability between animal models and clinical samples.
- Enabling preclinical biomarkers to be assessed in clinical phases.
- Data-driven and rational dose selection.
- Reduction of uncertainty in First-in-Human studies.
With transition into the clinical phase, Safety Lab and central laboratory infrastructures are engaged to ensure participant safety and longitudinal evaluation of parameters aligned with preclinical findings.
- Hematological and biochemical safety monitoring.
- Reduction of site-to-site variability through a central laboratory approach.
- Early detection of preclinically anticipated risks in clinical phases.
Strategic Contribution and Decision Quality
The preclinical-to-clinical continuum approach provides strategic value in addition to scientific rigor. This model aims to reduce clinical failure risk and support stronger scientific justification at early decision points.
- Reduction of failure risk in clinical phases.
- Avoidance of unnecessary repeat studies.
- A more predictable and manageable clinical development process.