One Partner with Complete Diagnostic Capabilities
As a Contract Diagnostic Organization, we’re a ‘one-stop shop’ for biopharmaceutical companies seeking diagnostic development and 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 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 Services and Capabilities.
Research & Development
- Biomarker discovery and validation (molecular, protein, other)
- 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
- Compliant labeling
- Software documentation
- Third party review by Accredited Persons (AP)
Manufacturing Services
- ISO 13585 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
Laboratory Services
- 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