Unified laboratory operations
- Central laboratory testing
- Specialty biomarker and advanced assay support
- Global logistics and sample management
- Integrated data management and reporting
Clinical Trial Phases
Specialty lab testing and central laboratory support from discovery through to post-market studies.
End-to-end support across all trial phases
Laboratory strategy shapes clinical outcomes from the earliest stages of development. The decisions made during discovery, around biomarkers, assay design, and data workflows, directly influence how efficiently programs progress through each subsequent phase.
Cerba Research combines specialty testing expertise with global central laboratory operations to support programs from preclinical research through phase IV studies.
Our teams work with biotech and pharmaceutical organizations to align scientific, operational, and data strategies early, reducing complexity as studies scale across regions, indications, and patient populations.
Our integrated capabilities span:
- Biomarker discovery, validation, and clinical translation
- Assay development for regulated environments
- Global sample management and logistics
- Standardized testing and data integration across trial phases
From protocol design to database lock, our teams are structured to grow with your program at every stage.
Integrated laboratory capabilities, phase by phase
Preclinical development
Build a strong foundation for clinical development
Preclinical research establishes the scientific and operational framework for clinical studies. Reliable laboratory data at this stage supports candidate selection, assay readiness, and transition planning for first-in-human studies.
How we support you:
- Bioanalytical and safety testing support
- Assay optimization and validation planning
- Biomarker strategy development
- Sample workflow and logistics planning
- Laboratory support for IND-enabling studies
By aligning laboratory workflows early, we help reduce delays between preclinical and clinical phases while supporting continuity across study programs.
Phase I: First-in-human
Generate early safety and biological insight
Phase I studies require rapid, high-quality data to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and early biological activity.
How we support you:
- Central laboratory safety testing
- PK/PD and immunogenicity assessments
- Rapid turnaround for high-frequency sampling
- Real-time reporting and critical value monitoring
- Biomarker analysis supporting proof-of-mechanism studies
Our integrated specialty and central laboratory model supports timely data delivery during dose escalation and early clinical decision-making.
Phase II: Proof-of-concept
Support efficacy evaluation and patient stratification
Phase II is where scientific insight translates into clinical potential by generating the clinical and biomarker data needed to evaluate therapeutic potential, refine study design, and guide later-stage development.
How we support you:
- Biomarker testing for exploratory and secondary endpoints
- Patient stratification strategies
- Specialty assays across genomics, immunology, and cell therapy
- Standardized central laboratory operations across study sites
- Bioinformatics and data interpretation support
We help teams generate clinically relevant insights that strengthen proof-of-concept evaluation and support progression into phase III studies.
Phase III: Pivotal trials
Deliver global consistency at scale
Large, multicenter clinical trials require harmonized laboratory operations, consistent methodologies, and reliable sample management across regions.
How we support you:
- Global central laboratory testing across extensive site networks
- Harmonized protocols and standardized laboratory platforms
- End-to-end sample tracking and lifecycle management
- Regulatory-compliant documentation and reporting
- Integrated data management across study partners
Our global infrastructure and standardized workflows help maintain consistency across sites while supporting regulatory submissions and large-scale study execution.
Regulatory submission and launch
Prepare laboratory data for regulatory review
As therapies approach approval, data quality, traceability, and documentation become increasingly critical to regulatory readiness.
How we support you:
- Regulatory-ready laboratory datasets
- Companion diagnostic and assay validation support
- Quality systems aligned with CAP, CLIA, ISO, and ICH M10 standards
- Audit-ready documentation and reporting processes
We support regulatory submissions through standardized quality processes, scientifically robust data generation, and compliant laboratory documentation.
Lifecycle management and post-market studies
Support ongoing evidence generation after approval
Clinical development continues after commercialization through long-term safety monitoring, additional indications, and real-world evidence generation.
How we support you:
- Phase IV and post-marketing studies
- Long-term safety monitoring and patient registries
- Biomarker expansion and diagnostic development
- Support for label extension studies and new indications
Our integrated laboratory model helps maintain operational and scientific continuity throughout the product lifecycle.
Why partner with us across your clinical trial phases?
Global scale, local execution
- Harmonized laboratory operations across five continents
- 3,000+ collection sites supported by global logistics networks
- Deep regional knowledge with consistent global quality
Scientific depth meets operational excellence
- Expertise across oncology, immunology, infectious diseases, and rare diseases
- Advanced platforms including next-generation sequencing (NGS), flow cytometry, proteomics, and digital pathology
- Support from protocol design through to database lock
Built to support evolving clinical programs
- Support for accelerated development timelines
- Flexible operational models
- Coordinated specialty and central laboratory support
- Scalable infrastructure for growing programs
- Collaborative support for resource-constrained teams
Explore our global clinical development capabilities
Sector expertise
Support for complex clinical programs with scientific and operational expertise across biotech, pharmaceutical, CRO, public health, and academic research environments.
Our DNA
Discover the values, scientific expertise, and collaborative approach shaping how we support clinical development and deliver meaningful impact worldwide.
Technology
Explore our advanced laboratory technologies supporting biomarker discovery, translational research, and data generation across clinical development.
Locations
Access global laboratory infrastructure through our labs and Centers of Excellence, with regional expertise and harmonized operations supporting multicenter clinical trials worldwide.
More insights into clinical trial development
The value of biomarkers in clinical development
Explore how biomarker strategies support patient selection, endpoint development, and decision-making across clinical trial phases.
Preclinical experiments brochure
Learn how integrated laboratory support strengthens translational research and prepares programs for clinical development.
Logistics solutions for sample kit management
Discover global logistics and sample management solutions supporting consistency, traceability, and operational efficiency across multicenter studies.
