Providing Custom Outsourced Clinical Testing Services

PacificDx provides a wide array of clinical and molecular testing services to bio-pharmaceutical, commercial, and clinical laboratories needing to outsource specialty or esoteric testing. Our high-complexity laboratory houses the latest in advanced molecular and non-molecular technologies and expertise to support your specific testing needs.

Full Service Contracted CLIA Test Development & Commercialization

PacificDx maintains licensure, accreditation, certification, and/or compliance with pertinent regulatory bodies and local, state, and federal laws where applicable. As a contract laboratory, our Quality Assistance group is committed to providing the highest-quality services for innovative new products

This commitment is based on the following principles:

Compliance with all current quality standards: GLP,GCP/GCLP, CLIA, CAP
Managing our activities according to a comprehensive quality system
Continual review and monitoring of all protocols, processes and testing
Client orientation to exceed their standards and continuously improve our performance
Enrollment in CAP’s proficiency testing program, including verifying testing performance and professional proficiency against pre-analyzed samples.
Full 50 State CLIA licensed and compliant
California — Clinical Lab License
New York — Clinical Lab License
Pennsylvania — Clinical Lab License
Rhode Island — Clinical Lab License
Maryland — Clinical Lab License

Supporting Clinical Trials with CLIA and GXP Testing Services

PacificDx can provide CLIA and GXP-validated assays to your demanding requirements. We can also develop and validate custom assays and ship supplies, and we offer complete clinical trial project management.

CLIA compliance is crucial in all clinical and clinical trial testing when laboratory test results influence clinical decisions. Our CLIA-certified lab maintains the highest quality standards (including CLIA, CAP, and GCLP) to protect the integrity of your precious clinical trial data. We offer testing services across all stages of drug development, from preclinical research to clinical trials and post-market monitoring, providing tailored solutions for all your high-complexity testing requirements.

Proprietary Commercialization, Validation and Testing

If you’re still in stealth mode or need an assay validated for use by only your organization, that’s no problem. RDx can set up completely confidential workflows, ensuring absolute privacy.
Need your own dedicated commercial facility? RDx can provide a “Full stack” contracted service, providing you with your own CLIA-approved CAP-accredited licensed facility maintained by RDx personnel and located either at your site or ours
Require a Site-specific 510(k) or PMA. PacificDx has extensive experience in submitting site-specific IVDs. We can provide full-service submissions at your site or ours