Unlinke traditional molecular diagnostic companies with their own internal projects, a CDO is a Contract Diagnostics Organization whose sole focus is the client’s needs. This setup allows diagnostic, biotechnology and pharmaceutical companies to outsource to a single partner offering integrated services within one organization. ResearchDx combines diagnostics research, a licensed and accredited clinical laboratory, manufacturing, and consulting in an integrated, technology-independent manner.
ResearchDx can design, manage, and coordinate all aspects in the development of a diagnostic product. Our services include:
- Assay development, platform evaluation and validation
- CLIA approved and CAP accredited validation of clinical samples and integrated clinical laboratory services
- Management at all levels of regulatory compliance, processes, applications and approvals including FDA submissions for 510(k) or Premarket Approval (PMA) clearances
- GMP manufacturing services
In the era of personalized medicine, the CDO is a new concept designed to aid pharmaceutical and biotechnology companies in addressing challenges in companion diagnostics development. This business model provides pharmaceutical companies a single outsourcing partner to initiate and manage the parallel development of companion diagnostic tests in synergy with drug development through FDA approval. The CDO combines all of the necessary services, including diagnostics research, an accredited clinical laboratory, project management and regulatory, manufacturing, and consulting in an integrated, technology-independent manner. The CDO focuses on its pharmaceutical/biotech partner’s business objectives and ensures the speediest path to market and quicker availability of valuable, personalized drugs and diagnostics for patients.
Strong Scientific Support: Each project is carefully evaluated and designed by experienced PhD-level scientists, Doctors and Pathologists. Our design and implementation teams are focused specialists, and all employees participate in our extensive ResearchDx training and competency programs.
Technology Independence: We do not sell instruments, nor receive a commission from instrument manufacturers. We remain platform agnostic, continuously evaluating new technology and instrumentation to ensure that our assays exceed all design specifications. We are free to choose the most appropriate technology for your project.
Accessibility: All projects have a dedicated project manager. We support and encourage regular client updates, and our customers are always welcome to all “Raw” data.
Fast Turnaround: ResearchDx specializes in rapid assay development; often cutting our competitors expected development times in half, without compromising quality or compliance.
Validation and Quality Assurance: Our assays undergo rigorous analytical and clinical validation, exceeding the specific regulatory guidelines set by CLIA/CAP and the FDA (GMP, GLP, GCP). We adhere to the highest standard in quality management system\and all projects undergo independent quality review.
Broad Range of Development Capabilities: Our development capabilities include a variety of approaches including IHC, Flow Cytometry, Sanger sequencing, quantitative PCR, Microarray, and Next-Gen sequencing technologies.