ResearchDx offers comprehensive support for running biomarker driven prospective trials and guidance for patient stratification in clinical trials.

Our goal is to deliver a cost effective, risk mitigated solution for design, development and validation of an assay to support your upcoming trial. We help with biomarker selection and validation, prospective patient enrollment, coordinating sample logistics, and clear strategic guidance for regulatory approval. We have a team of experts who understand the importance of identifying the right patients for your trial and have plenty of experience across the spectrum of technologies and platforms.

Whether you need proof of concept, initial assay design, tech transfer and validation or help with commercialization, we can deliver.

Biomarker Discovery / Validation

  • Exploratory/Proof of Concept Studies
  • RUO Assay Design and Development
  • Assay Optimization
  • Predictive Utility
  • Bioinformatics/Biostatistics Support

Clinical Trial Support

  • IUO/CTA Validation
  • Sample Logistics
  • Central Lab Testing
  • Kitting and Distributed Deployment
  • Fast Turnaround Time to Support Prospective Patient Enrollment

Regulatory/Manufacturing Support

  • Regulatory Strategy
  • IVD, PRE-IDE, PMA, 510(k) filings and FDA interactions
  • International Regulatory Filings
  • Compliance Auditing and Consulting
  • ISO 13485 Manufacturing
  • Custom Reagents, Assays, or Final Kits for Research, Clinical, or Final Product
  • OEM Reagents, Kit Components or Assays

Schedule a consultation with our research team to discuss your specific needs.

About Research Dx
ResearchDx is a full-service diagnostic development organization, providing a ‘start-finish’ partnership for the co-development of companion diagnostics.  At RDx, we design, manage, de-risk and coordinate every aspect of the diagnostics development process, from biomarker discovery, assay design and validation, clinical trial management and logistics, and regulatory submission. As a uniquely technology and platform agnostic solutions provider, we look at all available options to best support your project.
As your single CLIA, CAP and ISO13485 certified partner, we understand the challenges of CDx development and strive to provide a cost effective, de-risked path and clear strategic guidance. RDx provides a flexible process that is agile and adaptable and we dedicate ourselves to the success of our partners.