Regulatory evidence plan
Start from the intended use and the decision the submission must support. Population, setting, operators, comparator, endpoints, and claims are built around the evidence the pathway requires.
Study design using data, not questionnaires.
Know where eligible patients are, how samples will be collected and tested, and what evidence regulators will require—before the protocol is finalized.
The problem
Design for how care actually happens.
The conventional process writes a protocol, then asks investigators whether they can run it. Studies built on surveys fail quietly through slow enrollment, the wrong patient mix, workflows sites do not perform, or samples the laboratory cannot use.
RDI starts with the intended use, patient population, standard of care, specimen and testing workflow, and regulatory endpoint. Then we design a study that can actually run, drawing on 300+ IVD trials since 2008.
Where your patients are.
RDI does the analysis to find the physicians that see your patient population. This shapes the approach — not the other way around.
RDI HQ + Lab — Van Nuys, California
How we design
Key issues we analyze before you commit.
Patient and site strategy
Show where intended-use patients are already treated, which physicians see them, and which comorbidities affect eligibility. The site plan starts from observed care, not investigator estimates.
Align study requirements to standard-of-care
Map how patients are diagnosed, tested, and referred today, then design around workflows physicians already perform — before sites are selected.
Simplify sample workflow for sites
Design kit, handling, transport, comparator testing, QC, storage, and data flow as one chain before the first patient enrolls.
Prevalence and enrichment
When the statistics need a positivity rate the general population will not deliver, design enrichment up front — screening, physician type, geography, seasonality — instead of discovering the shortfall mid-study.
Source and adjudication
Define what source supports each endpoint, what reviewers need to see, how disagreements resolve, and how final classifications enter the dataset.
Regulatory range
Eighteen years of pure IVD specialization.
Submission
510(k)PMADe NovoPMA supplementCLIA waiverPre-submission (Q-Sub)RUO → IVD
Disease state
Infectious diseaseHepatitis (A/B/C)HIVSepsisCardiologyOncologyNeurology & Alzheimer'sEndocrine & metabolicDiabetesThyroidTransplantWomen's healthAutoimmuneHematologyCoagulationNephrology…and more
Technology
Clinical chemistryImmunoassayMolecular / PCRNext-gen sequencingHematologyMicrobiologyMass spectrometryLateral flow
Device & end user
Central-lab analyzersPoint-of-careCLIA-waivedOTC / at-homeCompanion diagnosticsLaboratory-developed tests
The network behind the design
A recruitment engine, rebuilt for every study.
Site strategy is only as good as the physicians you can actually reach. We maintain direct access to 34,500+ physicians across 67 specialties in all 50 states — and a recruitment engine that has activated sites in as little as 10 days, and found hard-to-find patients across 300+ IVD trials since 2008.
Physicians in the RDI network2018 – 2026 · cumulative
Scale
34,500+ physicians across all 50 states and 67 specialties — from cardiology and dermatology to transplant medicine and pediatric urgent care.
Velocity
The network grows faster than any study timeline — thousands of physicians and ~150 site relationships added each year, with 19,000 study-specific outreach touches in a typical year.
Precision
57 indication-specific campaigns launched in the first half of 2026 — transplant immunosuppressants to pediatric strep — each targeted to the physicians who already see the intended-use population.
Speed
For a matched study, a site is typically activated within 2–4 weeks of first physician contact, with a first patient enrolled about two weeks later.