Our GCP-compliant, Clinical Laboratory is CLIA certified by The Centers for Medicare & Medicaid Services (CMS) and accredited by the College of American Pathologists (CAP) for clinical NGS. Our commitment to providing reliable, cost-effective services and high-quality results remains paramount for our clinical service portfolio. We offer regulatory compliant services with fit-for-purpose quality assurance (QA) oversight and documentation, supporting projects ranging from RUO to CLIA validation and registration. We treat all customer information, study-related data, and intellectual property with the same degree of care and security that we do for our own. This allows our customers at both top-tier pharmaceutical companies and biotechnology start-ups the flexibility to utilize our regulatory services while trusting in our commitment to quality and communication.
Development of fit-for-purpose assays supporting prospective and retrospective clinical trials
Sample sourcing and fit-for-purpose assay development for comparator testing and analytical validation studies
Biospecimens are processed following GCP guidelines in our CLIA certified, CAP-accredited laboratory by CLIA-trained personnel on CLIA-qualified equipment. Our clinical lab offers flexibility in documentation and QA oversite depending on client needs. This offering is ideal for biomarker discovery, monitoring, and exploratory endpoints.
Customizable workflows specifically engineered to maximize quality results for difficult samples types.
We offer fit-for-purpose CLIA assay validations for any of our regulatory environment offerings, client-specific assays, or custom assay development. Validations can include test registration if applicable for client studies. Recommended if data is used for diagnostic purposes.
CLIA & CAP Validation
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