CLIA Certified Laboratory
CLIA-Certified Laboratory Services, Assay Development, and Clinical Study Support
Integrated laboratory services supporting assay development, LDT implementation, clinical trials, and regulatory studies.
CLIA-Certified Testing Infrastructure
Specialty Laboratories operates a CLIA-certified laboratory with established quality systems supporting both clinical and research applications. Our laboratory environment is designed to ensure reproducibility, data integrity, and compliance across all testing workflows.
Validated testing workflows and standard operating procedures
Rigorous quality control and data review processes
Flexible sample handling and study-specific protocols
Secure data management and reporting
Contract Laboratory Services
Flexible laboratory partnerships supporting development, validation, and clinical programs
Customized Testing Protocols
We design and execute study-specific testing protocols aligned with your scientific and regulatory objectives. Our team works closely with yours to implement workflows that integrate seamlessly with your development and clinical programs.
Scalable Capacity on Demand
From early feasibility studies to high-volume clinical testing, our laboratory infrastructure scales with your program requirements. We provide consistent performance while maintaining rigorous quality and compliance standards.
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Assay Development Expertise
Our scientists design and refine analytical methods tailored to your target analytes and sample matrices. We optimize sensitivity, specificity, and reproducibility through systematic parameter evaluation and validation protocols.
Comprehensive validation following FDA and CLIA guidelines including precision, accuracy, linearity, sensitivity, and specificity assessments. We provide complete documentation packages suitable for regulatory submissions.
Seamless transfer of established assays from your development team to our production laboratory. We ensure method equivalence through rigorous bridging studies and parallel testing protocols.
Custom multiplex panel design for research and clinical applications. We leverage our expertise across immunoassay, molecular, and mass spectrometry platforms to create comprehensive biomarker solutions.
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LDT Implementation
We support the full lifecycle of laboratory developed tests (LDTs), from assay development through analytical validation and clinical implementation within a CLIA-certified environment.
Evaluation of your assay against regulatory and clinical requirements, including study design and validation planning.
Execution of validation studies to establish performance characteristics and support clinical use.
Integration of assays into CLIA-certified workflows with appropriate documentation, quality systems, and ongoing performance monitoring.
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Clinical Trial Services
We provide integrated laboratory services for clinical trials, supporting study endpoints, biomarker analysis, and regulatory data generation from early development through multi-site studies.
Central Lab Services
Standardized testing protocols, sample management, and data reporting systems designed for multi-site clinical trials, ensuring consistency, traceability, and audit readiness.
Companion Diagnostics
Development and validation of biomarker assays to support patient stratification, clinical trial enrichment, and precision medicine strategies.
Integrated Laboratory Support for Clinical Trials
From assay development through clinical study execution, we provide laboratory services aligned with protocol requirements and regulatory expectations. Our team supports sample processing, biomarker analysis, and data generation with strict adherence to study timelines and quality standards. Dedicated project management ensures coordination of testing schedules, sample logistics, and reporting deliverables. Secure data systems and real-time reporting enable efficient decision-making throughout your clinical program.
Regulatory & FDA Support Advantages
Partner with a laboratory experienced in regulatory-driven study design and validation. Our quality systems and documentation support reduce risk and help accelerate your path to clinical implementation and regulatory submission.
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Specialty Labs
In-House
CLIA-certified laboratory with inspection-ready quality systems
Experience supporting FDA submissions and regulatory strategy
Validated SOPs and documentation aligned with regulatory requirements
Experienced scientific and regulatory support teams
Support for 510(k), De Novo, and PMA submissions
Audit-ready quality systems and CAPA processes
Advance your development programs with laboratory expertise spanning assay development, clinical validation, and regulatory support. We provide the scientific and operational foundation to move diagnostics from concept to clinical use.
Biomarker Discovery
Identification and validation of biomarkers using immunoassay and molecular platforms. We support feasibility studies, analytical validation, and translation into clinically actionable assays.
Sample Repository
Secure biospecimen storage and management with full chain-of-custody documentation, temperature monitoring, and retrieval systems to support longitudinal studies and regulatory requirements.
Custom Protocols
Collaborative method development tailored to your uniqCollaborative development of assay protocols tailored to your sample types, study objectives, and analytical requirements, with a focus on reproducibility and regulatory alignment.ue research questions, sample types, and analytical requirements.
Data Integration
Structured data packages with statistical analysis, quality metrics, and reporting formats aligned with clinical study requirements and regulatory submissions.
Advance Your Diagnostic Program with a Trusted Laboratory Partner
Connect with our scientific team to discuss how Specialty Laboratories can support your clinical testing, assay development, or regulatory objectives.
Confidential Consultation • No Obligation