RDI is your full-service, integrated IVD CRO
With clinical trial services to support the full life cycle of your product, we are dedicated to IVD and have the extensive domain expertise necessary to support you through all product validation pathways.
Backed by a technologically forward approach and extensive experience, we accelerate your IVD research.
Regulatory Consulting
By combining regulatory and clinical services, we save you time and increase the likelihood of your product’s approval. From the initial stages of defining the most effective regulatory pathway to the details of your study design and preparing submission documents, our team is dedicated to guiding you every step of the way.
By reaching out to the FDA with a proposal plan early and using our site network to guide feasibility, we help you avoid surprises and minimize delays.
1
Develop
Based on your product’s unique requirements and specifications, we use our experience in IVD development to determine an ideal regulatory strategy.
2
Submit
We manage your 510(k) pre-submission or PMA submission package to the FDA.
3
Design
RDI designs the IVD research studies necessary for analytical verification and validation, as well as clinical validation.
4
Conduct
Our CRO stands by to support your IVD studies with laboratory infrastructure, clinical sites, and clinical research services.
5
File
We file your final submission material to the FDA and ensure successful completion of your regulatory process.
1
Develop
Based on your product’s unique requirements and specifications, we use our experience in IVD development to determine an ideal regulatory strategy.
2
Submit
We manage your 510(k) pre-submission or PMA submission package to the FDA.
3
Design
RDI designs the IVD research studies necessary for analytical verification and validation, as well as clinical validation.
4
Conduct
Our CRO stands by to support your IVD studies with laboratory infrastructure, clinical sites, and clinical research services.
5
File
We file your final submission material to the FDA and ensure successful completion of your regulatory process.
Clinical Trial Support
We understand that IVD research requires a unique approach compared to other modalities.
With a deep understanding of the factors that influence your IVD trial’s success, we provide comprehensive clinical trial support and guidance. Our services span consent, data capture, site billing, and remote monitoring, all built specifically for the IVD industry.
Clinical Lab Services for IVD Trials
We understand that IVD starts and ends in the lab, yet many labs are not well equipped or interested in the effort that research requires.
At RDI, we have our own high-complexity CLIA lab and numerous partnerships with research labs and commercial clinical labs, this affords near limitless resources for the evaluation of developing clinical laboratory technologies.
Access to Any Instrument and Assay
RDI understands that IVD development requires specific assays and specific instruments to either help validate your R&D work or serve as the predicate device in a submission. RDI has access to many different analyzers located in its facility or at its partner labs. These instruments span immunoassay, chemistry, and molecular sequencing, and we are constantly adding to our network.
Our available instruments and assays are always evolving. If you do not see the assay or instrument your looking for, please contact us to explore solutions.
BARDA
With over 30 years of experience in federal acquisition, we have successfully led advanced R&D projects and navigated USG funding landscapes. Our strategic guidance and application support streamlines the acquisition process, positioning your projects for accelerated success and impact.
