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. 

RDI specializes in IVD trial design, with a thorough understanding of the complex requirements of these studies. We consider healthy & diseased samples, diversity by geography and demographics, and use of prospective, remnant, or contrived samples to tailor study design to your needs and meet the agency’s regulatory requirements.  

RDI uses insurance claims data for more than 2 million physicians to engage the right providers with the right study. This accelerates study startup and enrollment while allowing for more accurate project timelines. We then treat these sites as repeat relationships, building our network and increasing confidence in site quality.  

Through our established IRB relationship with Advarra, you benefit from fast turnaround, quick resolution of any issues, and expert guidance, including international Canadian support.  

RDI works with facilities across the U.S. to support and streamline your sample collection and testing operations.  

Facilities include:

  • CLIA laboratories 
  • Doctors offices 
  • Private hospitals 
  • STD centers 
  • Gyms 
  • Geriatric centers 

Our biostatistics teams streamline your IVD product development process, enhancing the probability of success with precise study design, optimal sample size determination, and rigorous data analysis techniques. By ensuring data quality and integrity, we help you make data-driven decisions faster. Our experts manage the intricacies of your study, ensuring statistical power, regulatory compliance, and robust results, ultimately accelerating your path to market. 

RDI’s fully integrated clinical trial management system brings together software, hardware, and processes to seamlessly integrate consent, data capture, site billing, and remote monitoring, all built specifically for the needs of IVD research.  

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.

Through our CLIA lab network and high-complexity lab in California, RDI can: 

  • Serve as a clinical site for IVD validation and verification studies 
  • Access remnant/banked samples from labs that see over 2 million tests annually 
  • Test research samples and accommodate project requests (media, instrument, or handling)  
  • Provide flexible lab space to place RUO instruments and/or purchase them for projects 
  • Source almost any predicate device  
  • Test samples on platforms from different manufacturers at the same time 

Quest Diagnostics

  • Access to one of the largest test menus in the U.S. 
  • Ability to accommodate tests that may be required for a study but not part of the standard of care 
  • Consistent testing for samples collected anywhere in the U.S. 

Regional Commercial CLIA Lab Partner I

Central and Southern California, Nevada, and American Samoa 

  • Founded in 1996
  • Specializing in women’s health, molecular testing, and pathology 

Regional Commercial CLIA Lab Partner II

California 

  • Physician-owned 7,000+ sq. ft. laboratory 
  • Focus on gastrointestinal and gynecological pathology 

Regional CLIA Lab Partner III

17 locations in New York & New Jersey 

  • Largest NY/NJ independent in-network diagnostic laboratory 
  • Testing across a wide range of specialties (e.g., cardiology, nephrology, oncology/hematology, infectious disease)  

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.  

  • Beckman Coulter Olympus AU480 
  • Beckman Coulter Olympus 5800 
  • Siemens Healthineers Advia 1800 
  • ESA Lead Analyzer 
  • Roche Cobas e 411 

  • Siemens Healthineers ADVIA 120 
  • Abbott Cell-Dyne 3200 
  • Beckman Coulter Coulter LH 750 
  • Becton Dickinson Facscount 
  • Hematek 1000 Slidestainer 

  • Siemens Healthineers IMMULITE 2000 
  • Siemens Healthineers Centaur XP 
  • Siemens Healthineers Centaur XPT 
  • Siemens Healthineers Atellica IM 
  • Siemens Healthineers SMS Vista 
  • Abbott Elyse 
  • Abbott IMx 
  • Abbott Architect 
  • Beckman Coulter Access 2 
  • Biosite Triage meter plus 
  • Biomerieux miniVidas Blue 
  • DiaSorin Liaison 
  • Intron DX Hydrogamma16 
  • Medica EasylyteElectrolysis 
  • Roche Cobas e411 

  • Iris iQ 200 
  • Iris iChem VELOCITY 

  • Siemens Healthineers Sysmex CA-1500 
  • Beckman Coulter ACL Advance 
  • Beckman Coulter ACL 1000 
  • Beckman Coulter IL ACL 100 & ACL 3000 

  • Biorad Variant Turbo II  
  • Tosoh G7 

  • Epson Hi-Res Gel Scanner 
  • Sebia Hydrasys Gel Electrophoresis System 

  • Abbott M2000 
  • Abbott M2000RT 
  • Abbott Commander 
  • Abbott Reader 
  • ABI 3100DNA sequencer 
  • ABI Gene Amp2400 
  • ABI Prism SDS7000 
  • ABI 9700 Dual Head PCR 
  • BioFire FilmArray 
  • Cepheid GeneXpert 
  • GeneProbe Leader 450I 
  • GeneProbe Tirgis 
  • GeneProbe Robatic System 
  • Life Technology Quant Studio 12K 
  • Eppindorf EP5075 
  • Roche Cobas Amplicor 
  • Roche Magna Pure 96 
  • Roche Magna Pure LC 
  • Kodak EDAS 290 Gel System 
  • Luminex 100 & 200Xmp 

Electrolytes

  • Chloride
  • CO2
  • Electrolyte Panel
  • Potassium
  • Sodium

Endocrinology

  • Basic Metabolic Panel
  • Calcium
  • Comprehensive Metabolic Panel
  • Cortisol
  • DHEA-S
  • Estradiol
  • Free T3
  • Free T4
  • FSH
  • Glucose
  • hCG
  • Hemoglobin A1c
  • hGH
  • IGF-1
  • Intact PTH
  • LH
  • Lipase
  • Phosphorus
  • Progesterone
  • Prolactin
  • PSA, Free
  • PSA, Total
  • SHBG
  • Testosterone
  • TSH
  • Vitamin D

Hematology 

  • CBC with Auto Diff
  • Differential (manual)
  • Ferritin
  • Folate
  • Hematocrit
  • Hemoglobin
  • Hemogram
  • Homocysteine
  • Iron
  • LDH
  • Magnesium
  • MCH
  • MCHC
  • MCV
  • MPV
  • Platelets
  • RDW
  • Red Blood Cell Count
  • Transferrin
  • Vitamin B12
  • White Blood Count

Liver

  • Albumin
  • Alkaline Phosphate
  • ALT
  • AST
  • Bilirubin
  • CRP
  • GGT
  • Hepatic Function Panel

Lipids

  • APO1
  • APOB
  • Cholesterol
  • HDL
  • LDL
  • Lipid Panel
  • Triglyceride

Microbiology and Infectious Disease

  • Anti-SARS-CoV-2
  • Borrelia burgdorferi
  • BV
  • C. Diff
  • Chikungunya
  • CMV
  • CT/NG
  • CV/TV
  • Dengue
  • EBV
  • H Pylori
  • HAV HBV
  • HCV
  • Hepatitis A
  • Hepatitis B
  • Hepatitis C
  • HIV
  • HPV
  • HSV
  • Measles
  • MRSA
  • Mumps
  • Mycoplasma genitalium
  • PhenoTest BC
  • RPR
  • Rubella
  • SARS-CoV-2
  • Syphilis
  • Toxoplasmosis
  • Trichomonas vaginalis
  • VCA
  • VZV
  • WNV
  • Zika

Renal

  • Albumin
  • BUN
  • Creatinine
  • Microalbumin
  • Renal Function Panel
  • Total Protein
  • Uric Acid 

BARDA

At RDI, our BARDA consulting services leverage extensive expertise and insider understanding to help you secure nondilutive funding for your IVD research.

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. 

Connect With
IVD Experts

Accelerate your research with a CRO that is dedicated to IVD products. Reach out to RDI to discuss your trial’s needs and our tailored solutions. 

Contact Us