As a Contract Diagnostic Organization, we’re a ‘one-stop shop’ for biopharmaceutical companies seeking diagnostic development and GMP manufacturing services. ResearchDx offers a comprehensive range of biopharma services to build, validate and deliver a regulatory-approved diagnostic assay through the efficiency of outsourcing to a single partner.
Your project is unique—and, unique is our specialty. With all diagnostic services housed under the same roof, you will have but one point of contact for your project rather than the many contacts associated with multi-vendor contracts. We manage and ensure every project is designed, implemented, and stays on target with your goals and schedules. And, should your project timelines or priorities need to shift — as your single IVD diagnostics resource, we have the flexibility to adapt to meet your needs. We maintain proficiency, competency, and expertise in all areas of diagnostics.
Schedule a consultation with our research team to discuss your specific needs.
Explore our Broad Range of BioPharma Services and Capabilities
Research & Development
- Biomarker discovery and validation (molecular, protein, other)
- Platform agnostic, your platform or ours
- NGS platforms—Illumina, Thermo Fisher, etc.
- PCR platforms—Qiagen, Thermo Fisher, ABI, etc.
- TMB for Immunotherapy
- MSI for Immunotherapy
- Assay/kit development and validation
- Platform evaluation and automation
- Studies to establish biological baseline
- Broad, multi-platform technology capability (no bias)
- LDT/custom development/clinical validation
Clinical Trials and Consulting
- Complete clinical trial services, program management, and support
- Clinical trial strategic consulting
- Reference trial testing services
- Clinical primary site testing
- Analytical and clinical testing
- Complete data management program support
Regulatory and Quality
- Regulatory strategy (e.g., FDA)
- Regulatory agency interactions
- IVD PRE-IDE, PMA, and 510(k) filings
- International regulatory filings
- Compliance auditing and consulting (GLP compliance)
- Compliant labeling
- Software documentation
- Third-party review by Accredited Persons (AP)
- ISO 13485 GMP manufacturing compliance
- Custom reagents, assays, or final kits for research, clinical, final product
- Molecular/non-molecular IVD development
- OEM reagents, kit components, or assays
- Certificates of Analysis (COA)
- Sample collection kits
- Premier high-complexity molecular specialty testing resource
- Fully credentialed clinical laboratory (CLIA, CAP, multi-state licensure)
- Broad, multi-platform and technology capability (no bias)
- Preclinical, clinical trial and GLP testing resource
Dedicated Project Resources
- Dedicated project management
- Scientific and medical expertise in all areas of IVD diagnostics
- Premier credentialed high-complexity CLIA laboratory
Our CAP/CLIA certified lab, PacificDx offers state-of-the-art facilities and expertise to meet your immediate clinical and pre-clinical needs for high-quality clinical and biopharmaceutical testing services.
Schedule a consultation with our research team today.