RDI · your IVD CRO

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.

A different model

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 →

Client wins

Different approach, same study, extraordinary outcome.

Enrollment rescue

A stalled healthy reference-range study for a new assay panel

Challenge

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.

Outcome

RDI took the rescue mid-study and enrolled 1,240 subjects across ~20 sub-cohort quotas — database locked on the sponsor's date, 15 Dec 2025. The only difference was the approach.

High-stakes

A mission-critical trial

Challenge

A midsized IVD manufacturer 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.

Outcome

CLIA waiver + 510(k) granted · client's market expanded to $1 billion

How we help

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.

FeasibilitySite IDCollectionTestingDataSubmission

Be your teamprotocol → submission

Power your teamhard samples

Use our CLIA / CAP labtesting only

RDI owns it stays with you

See how RDI would run your study.

Study design

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 — informed by our 18 years of experience and 300+ trials.

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.

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.

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 its 300+ trials.

A network that compounds. Every study adds physicians, sites, and response history that the next study starts from.

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.

See how RDI would design your study.

The laboratory

IVD starts and ends in the lab. Ours.

A high-complexity, CLIA-certified and CAP-accredited laboratory dedicated to your study.

The lab

A lab team dedicated to your study.

RDI's laboratory handles clinical and research specimens under the same quality system and with the urgency diagnostic studies require. It also serves as the central biobank and logistics hub for our sites and sponsors — assembling kits, receiving and accessioning specimens, completing required testing, and storing samples according to protocol. Our laboratory staff works alongside the clinical team, taking work off the sites and making it easier for them to participate in the study.

Dr. Michael Samoszuk

Chief Scientific Officer & Medical Director

Owns the science and testing — a pathologist directs specimen handling and assay work, not a project manager.

Lara Flores

Chief Operating Officer

Owns execution across every active study — the operational lead from kit-out to database lock.

CertificationCLIA certified · CAP accredited

Facility8,000 sq ft · Van Nuys, California

RolesClinical site · central lab · reference lab

What we manage

What we manage here.

Reference testing

RDI provides high-complexity reference testing for physicians and sponsors through its own test menu. When specialized testing sits outside our menu, we coordinate send-outs through qualified national and specialty reference laboratories.

Laboratory site for analytical and clinical validation studies

Sponsors can place instruments in our laboratory and use RDI as an assay validation site. Our medical director can serve as the site principal investigator, and our technologists can be trained on the sponsor's system, assay, and protocol.

Study logistics and storage

Our laboratory team is the operating center for RDI's prospective collections. They assemble and distribute collection kits, receive and accession specimens, complete quality checks and required testing, and prepare samples for storage or shipment. They work in lockstep with the clinical team so the right sites have the right kits at the right time.

Remnant sample sourcing

Through RDI's own testing and qualified partner laboratories, we have access to over 2 million leftover specimens and can match the study's matrix, analyte range, positivity, volume, stability, and documentation requirements.

Relevant proof

Proof from the bench.

Four-hour window from vein to instrument across draw, courier, process, and instrument stages

Time-critical specimen logistics

Four hours from vein to instrument.

A multi-analyte stability program required specimens to be collected, transported, processed, and tested inside a four-hour window and then tested over two years. RDI built the collection workflow around that deadline and ran the work on three sponsor-placed analyzers in Van Nuys.

186,300 timepoints · 3 analyzers · 4-hour window

US map showing sample shipping routes from 27 urology sites converging on RDI's central lab

Critical central-lab for time-sensitive study

Twenty-seven sites. One lab. One results stream.

For a national PSA study, RDI became the single specimen-and-results hub for 27 urology practices across the US — the team ensured samples were tested and entered into the EDC in real time, as the value was critical for study inclusion criteria. Few labs are equipped with a full lab team and research-aware coordinators.

27 sites · one central lab · full chain of custody

Two benchtop immunoassay analyzers set up side by side in the lab for a head-to-head method comparison

Independent comparative evidence

Sponsor-funded. Independently designed, run, and reported.

Tosoh funded the comparison; RDI designed the usability protocol, ran 40 paired remnant specimens in duplicate, and took responsibility for the conclusions. The study showed excellent TSH and FSH agreement and a materially lighter operating burden for the AIA-CL300. The outcome was a high-quality white paper suitable for marketing.

Read the Tosoh white paper →

See how our lab can accelerate your study.

Diagnostica™

The software isn't the product. The judgment is.

Diagnostica™ is our trial software, built in-house for diagnostic studies. You don't license it — it comes with every study we run.

What it is

Built for diagnostics, not bent toward them.

Generic trial software is built for drug trials and then bent, expensively, toward diagnostics. We built Diagnostica™ around what diagnostic studies actually run on — specimens, analyzers, source records, positivity, adjudication — configured around your protocol instead of asking the protocol to fit the software.

You're not really buying software. You're getting the protocol's judgment built into the work: a coordinator's second set of hands, a lab supervisor that never looks away, a protocol expert in every study — plus a compliant eTMF, EDC, and remote source capture, all 21 CFR Part 11.

How it runs

Software is one part. The study runs on all three.

Each part does a job the other two can't.

Software, hardware, and people, working as one loop — source captured at the bench, every entry checked against it, and problems flagged before they become deviations.

Software

The judgment

The protocol's logic, thresholds, and clinical decisions, built into the workflow.

01Prompts the recommendation at the right visit — the clinician still makes the call

02Fires thresholds and flags the moment a value lands

03142 calculations · 1,900+ rules, per study

Hardware

The reach

The tools that put the system where the work actually happens.

01Scanners capture source at the bench, not after the fact

02Tablets follow the patient's visit, in the order it happens

03Barcodes track every tube, volume, and cryobox position

People

The check

The team that keeps the record clean enough to trust over time.

01Coordinators enter against a live workflow, not a blank form

02Our team verifies every entry against source between visits

03Monitors catch what's slipping before it becomes a deviation

software + hardware + people · one loop, running continuously

Case studies

Same platform. Two very different studies.

Here's what Diagnostica™ looks like when the workflow is shaped around the protocol — not the other way around.

◆ Diagnostica™ · Visit 7 · Month 6NEEDS REVIEW

Tacrolimus is below target — review the dose before this visit closes.

4.1 ng/mL · below rangetarget 5.0–15.0

Review dose

Flagged automatically · the coordinator decides.

What the coordinator sees at the visit: Diagnostica™ reads the result and prompts the next step.

We put a transplant nurse's judgment beside the coordinator.

This protocol carried optional, algorithm-guided immunosuppression decisions a coordinator could easily miss in a PDF. A normal EDC would just store whatever got typed. We built the algorithm into the workflow, so at the right visit it surfaces what the protocol recommends and why — a transplant nurse's judgment beside the coordinator. The software surfaces the recommendation; the clinician still makes the call.

◆ Diagnostica™ · STB-0859 · Subj 024ON SCHEDULE

Next testing timepoints

Consent · baseline drawJun 1

TodayJun 4

T1 · +5 days · due in 2 daysJun 6

T2 · +14 daysJun 15

T3 · +30 daysJul 1

Every window counted from consent — nothing gets missed.

What the lab sees: Diagnostica™ tracks every timepoint window from consent.

Software that supervises the lab schedule — and monitors the study in real time.

No one can hold this schedule in their head: 27 analytes with their own rules, ~50 subjects each, 138 timepoints apiece, four storage conditions, two years. So the software does the supervising — it knows what's due, flags what's slipping before it becomes a deviation, and catches an out-of-spec result the moment it lands.

See how Diagnostica™ can change your study.

The work, on the record.

See selected operational reports of our studies, the frameworks we use to design them, and our general opinions about clinical research.

Operations report · 01

Alzheimer's plasma biomarkers: an LAR consent pathway, built up front

~400 subjects across up to 5 specialty sites, split between cognitively normal controls and clinically confirmed Alzheimer's. Many confirmed patients can't legally consent for themselves — so the study only works if a legally authorized representative (LAR) pathway is built in from the start.

Operations report · 02

An academic pediatric ER, opened in 85 days

Site live 85 days after the intro call, on a path that normally runs 3–6 months. RDI's scope was deliberately narrow — find the site, make the introduction, own the contract and payments — powered by its peer-to-peer MD network in hospital critical care. The engagement later grew to ~5× its original value.

Operations report · 03

Chronic Hepatitis B: reaching patients through their physicians

149 subjects across two community clinics, with a 98% qualified rate at first-collection close. The patients are behind the doors of the physicians who already treat them — often behind a language barrier.

Operations report · 04

1,240 healthy subjects for a reference range, locked on time

1,240 healthy volunteers from the general population across ~20 sub-cohort quotas — adults by age and sex, pediatric by Tanner stage, pregnant by trimester — collected across 12 sites, cold-chained to the lab, and locked on the sponsor's fixed date.

Operations report · 05

Transplant drug monitoring: a tiered site network

244 subjects across 7 transplant centers. Five drugs across heart, liver, and kidney — a matrix of sub-cohorts, each behaving like its own sub-study.

Operations report · 06

Thyroid reference ranges: enrolling more people doesn't help

564 healthy adults across 9 sites. CLSI EP28 dictates the demographic mix of the reference group, so the constraint is who each site can reach — not how many.

Operations report · 07

Ten blood draws per subject in five weeks, with the retention to finish

60 subjects × 10 visits, ~575 specimens through a single site, with a +376-specimen peak month. The study isn't enrolling 60 women — it's keeping all 60 through ten visits so the serial dataset doesn't collapse into dropouts.

Contact

Contact us

Tell us about the study. We're happy to sign an NDA first.

Emailinfo@rditrials.com Call818-224-4235

Lab & offices16760 Stagg Street, Unit 209
Van Nuys, CA 91406

Careers

A small, senior team that delivers.

We run diagnostic trials for the world's leading IVD manufacturers. There's no wasted seat here — every person makes the work better.

From the CEO

What we're building.

From the team

Operators on the work.

Who thrives here

What the work rewards.

Ownership

Small team, real accountability — you own outcomes end to end, not a narrow slice of a process.

Craft

The work is specialized and it matters. We care about getting the science and the operations right.

Range

You're as at home on the floor of a lab as you are in a sponsor meeting — and you like it that way.

Judgment

We hire people we can trust to make the right call, then give them the room to make it.

Open roles

Where we're hiring.

The team

Diagnostics specialists in charge.

Assay scientists, pathologists, and lab operators run the studies — not a handoff to generalists.

Leadership

The people accountable for your study.

Conall Arora

CEO

Acquired RDI in 2017 and has led the company since — building the team, the systems, and the physician network that let customers of every size benefit from RDI's specialist focus. Holds degrees in pre-med and economics from Columbia. Before RDI, invested in and operated businesses across software startups and public companies up to $2.5B in revenue.

Lara Flores

COO

Leads all operations at RDI — sample collection teams and the CLIA lab. Most recently ran Global Lab Operations at NeoGenomics. Before that, business services and clinical operations at Beaufort, an IVD CRO. B.S. in biochemistry from UCLA. Developed and validated 80+ assays across a career at LabCorp, Genzyme, One Lambda (Thermo Fisher), Pathway Diagnostics (Quest), and Amgen.

Dr. Michael Samoszuk

Chief PI · Medical Lab Director

Licensed physician and board-certified pathologist. Previously CMO at Roche Diagnostics, Ortho-Clinical Diagnostics, and Beckman Coulter. Before industry, directed the Hematology/Oncology Center for Quest Diagnostics and served as associate professor of pathology at UC-Irvine. Harvard Medical School graduate. 70+ peer-reviewed publications.

Dr. Elisa Romeo

Principal Investigator

Principal investigator for RDI's prospective collections. Formally trained scientist with a career developing, validating, and launching new diagnostic products — critical in obtaining 510(k), EUA, and CE approval for immunological assays, cancer biomarkers, and genetic molecular assays. Ph.D. in human physiology and biochemistry from the University of Zurich. M.S. in biology from University of Insubria.

Tamara McCaw

Regulatory Affairs

20+ years in IVD R&D and regulatory. Chemical engineer by training. Senior roles at Abbott and SQI Diagnostics. Specializes in FDA and global regulatory strategy, Q-submissions, and pathway design for diagnostics companies building toward clearance.

Liisa Johns

Quality Assurance

25+ years across IVD quality, compliance, and operations. Most recently directed quality strategy for Abbott's global toxicology business, scaling a compliant QMS across 17+ global sites. Deep expertise in ISO/IEC 17025 and FDA inspection readiness.

Want to work with us, or join us?

Talk to the team that will run your study — or see where we're hiring.

Careers →Contact Us →

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.

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.

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.

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

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.

Physicians in the RDI network2018 – 2026 · cumulative

A network that compounds. Every study adds physicians, sites, and response history that the next study starts from.

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

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.