For IVD Development, RELY ON RDI

Navigating the IVD development process requires a CRO with the domain expertise to truly understand your needs.

By partnering with RDI, you benefit from integrated services at every stage of your product validation process, backed by extensive experience developing assays for some of the largest manufacturers in the world.

Why RDI?

RDI offers comprehensive support throughout all IVD product validation pathways, leveraging our diverse physician network and high-complexity CLIA lab to deliver reliable solutions.

Our track record of completing over 170 trials and 15+ years of experience, combined with our technologically forward approach, instills confidence that we can guide your IVD development process, accelerate research, and deliver quality outcomes you can trust.    

With RDI, you benefit from:

Increased Likelihood
of Success

Our dedicated team consists of only IVD experts and our tailored protocols integrate the latest standards and methodologies. Backed by experience and knowledge from hundreds of trials, we enhance the likelihood of your product’s approval and success.

Transparency

Working with RDI is as transparent as managing your trial yourself, with the added benefit of our broad-reaching expertise. Regular, detailed updates ensure you’re always aware of progress and milestones, and our user-friendly online portal gives you the access you need, anytime.

Efficiency

We ensure efficiency from the start of your partnership with us, beginning with our straightforward contract terms to accelerate project initiation. As your trial progresses, our advanced electronic data capture systems streamline data collection and improve accuracy. Our meticulous sample management system tracks and maintains the integrity of every sample, and our network of labs streamlines testing timelines and sources leftover samples.


Tailored Services

We are dedicated to your IVD development needs at any point in your product’s life cycle, with flexible service options to fit your needs. We consider the full spectrum of your business goals and the needs of your trial, exploring opportunities to collaborate and innovate together.

  • Opportunity assessment
  • Unmet clinical need
  • Target customer(s)
  • Market and market size
  • Messaging strategy
  • Geography
    • FDA
    • IVDR
  • Reimbursement plan

  • Disease/health condition
  • Unmet clinical need 
  • Gold standard 
  • Current landscape 
    • Diagnostic tools 
    • Best practices 
    • Clinical guidelines 

  • Risk classification 
  • LDT regulated by CLIA 
  • IVD 
    • 510(k) 
    • PMA 
    • de novo 
    • HDE 
  • Companion diagnostic
  • Kit manufacturing 

  • Performance characteristics 
    • Sensitivity
    • Specificity 
    • Negative predictive value 
    • Positive predictive value 
  • Test results 
    • Continuous score 
    • Discrete result 
  • Clinical significance

  • Health economics
  • Analytical validation 
  • Clinical validation/diagnostic clinical performance 
  • Clinical outcomes/clinical utility
  • Guided by publication strategy  

Ready to accelerate your IVD trial?

RDI stands out as one of the only collaborative, full-service partners dedicated to IVD research. Our focus and expertise position us to pave a clear path to FDA clearance for your product. Backed by vast resources and a commitment to transparent partnership, we are the trusted choice for IVD development.

Let's Talk