When the study outcome matters, rely on RDI.
Diagnostic companies choose us when the samples are hard to get, the timeline is short, and the next regulatory submission has to succeed.
Contact Us →We built a new way to run IVD trials.
Most CROs manage a plan. RDI gets the study done — by combining evidence-based enrollment, study design grounded in clinical reality, integrated sample and laboratory operations, technology built around the protocol, and senior diagnostics specialists.
Understand where the patients and the standard of care for your IVD.
Study design →Design the study that aligns the physician, their patients, and your intended use.
Study design →Integrate everything from the collection kit to the data export — our own sites, lab, biobank, and Diagnostica™ software.
Laboratory →Put diagnostics specialists — assay scientists and pathologists — in charge of the study.
The team →The names behind the method.
Different approach, same study, extraordinary outcome.
A stalled healthy reference-range study for a new assay panel
A global diagnostics leader needed reference ranges for a new assay panel — over a thousand healthy subjects across adult, pediatric (Tanner-staged), and pregnancy cohorts. The prior CRO had stalled the U.S. arm; the sites simply weren't delivering the quotas.
A mission-critical trial
Lumos Diagnostics came to us with a point-of-care device that had to align operator, patient, and clinical setting to meet strict regulatory requirements — on top of milestone-based funding for the program that made the stakes extremely high. RDI activated 10 sites in months, then retargeted positives outside the normal flu season, an enrichment strategy that kept the study on track.
Three ways clients bring RDI in.
From end-to-end program ownership to targeted laboratory support, RDI can lead the work or extend your team.
Be your teamprotocol → submission
Power your teamhard samples
Use our CLIA / CAP labtesting only
See how RDI would run your study.
Contact Us →When the study outcome matters, rely on RDI.
Diagnostic companies choose us when the samples are hard to get, the timeline is short, and the next regulatory submission has to succeed.
Contact Us →We built a new way to run IVD trials.
Most CROs manage a plan. RDI gets the study done — by combining evidence-based enrollment, study design grounded in clinical reality, integrated sample and laboratory operations, technology built around the protocol, and senior diagnostics specialists.
Understand where the patients and the standard of care for your IVD.
Study design →Design the study that aligns the physician, their patients, and your intended use.
Study design →Integrate everything from the collection kit to the data export — our own sites, lab, biobank, and Diagnostica™ software.
Laboratory →Put diagnostics specialists — assay scientists and pathologists — in charge of the study.
The team →The names behind the method.
Different approach, same study, extraordinary outcome.
A stalled healthy reference-range study for a new assay panel
A global diagnostics leader needed reference ranges for a new assay panel — over a thousand healthy subjects across adult, pediatric (Tanner-staged), and pregnancy cohorts. The prior CRO had stalled the U.S. arm; the sites simply weren't delivering the quotas.
A mission-critical trial
Lumos Diagnostics came to us with a point-of-care device that had to align operator, patient, and clinical setting to meet strict regulatory requirements — on top of milestone-based funding for the program that made the stakes extremely high. RDI activated 10 sites in months, then retargeted positives outside the normal flu season, an enrichment strategy that kept the study on track.
Three ways clients bring RDI in.
From end-to-end program ownership to targeted laboratory support, RDI can lead the work or extend your team.