Laboratory Animal Facility
Ethical, scientific, and regulatory-compliant preclinical research — generating safety, pharmacology, and toxicology data prior to transition into clinical research.
Introduction & 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 are delivered through Omega's internal units or authorized partner infrastructures complying with applicable standards.
Regulatory & 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.
HADYEK Approval
Approval by the Local Ethics Committee for Animal Experiments. All study protocols undergo ethical review before initiation.
3R Principles
Replacement, Reduction, and Refinement — minimizing animal use while maximizing scientific output and welfare.
EU Directive 2010/63/EU
Full alignment with European Union Directive on the protection of animals used for scientific purposes.
GLP Principles
Adherence to Good Laboratory Practice principles for reliability, integrity, and quality of preclinical safety data.
Animal Species & Housing Infrastructure
- 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 & Daily Monitoring
- 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 Applications & Procedures
Conducted by qualified personnel in accordance with approved protocols. Scientific data quality maintained while minimizing animal burden.
Safety, Toxicology & Pharmacology
Generation of safety and toxicology data prior to transition into clinical research.
Sample Management & Analytical Integration
Biological samples obtained from laboratory animals are processed and analyzed in an integrated manner with the HelixLab central laboratory infrastructure.
Traceable Collection
Blood, tissue, and biological samples with chain-of-custody approach.
HelixLab Integration
Biochemistry, hematology, and histopathology analyses on centralized platform.
Biorepository Storage
Long-term storage of animal-derived biological samples for reanalysis.
Preclinical to Clinical Continuum
Continuity between preclinical and clinical research phases is critical for scientific accuracy, patient safety, and operational efficiency. The Omega CRO ecosystem addresses this through an integrated and traceable framework.
Preclinical Phase: Laboratory Animals & Translational Preparation
Studies establish the scientific foundation for transition into clinical phases with respect to safety, tolerability, pharmacology, and toxicology.
Translational Bridge: Sample, Data & Interpretive Continuity
Samples evaluated in an integrated manner with HelixLab, enhancing comparability between animal models and clinical samples.
Clinical Phase: Safety & Central Laboratory Continuity
With transition into the clinical phase, Safety Lab and central laboratory infrastructures ensure participant safety and longitudinal evaluation.
Strategic Contribution & Decision Quality
Reduced Failure Risk
Reduction of failure risk in clinical phases through stronger preclinical foundation.
No Unnecessary Repeats
Avoidance of unnecessary repeat studies through integrated, traceable data transfer.
Predictable Development
A more predictable and manageable clinical development process.
Planning Preclinical Studies?
Discuss your preclinical-to-clinical transition plan with our integrated team.
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