IVD Clinical Trials Are Hard to Outsource

Pharma CROs Miss the Mark

  • Priced to match pharmaceutical business model
  • Often lack specific focus and cost-effectiveness required for diagnostic development
  • Processes not aligned with IVD nuances i.e. sample and testing

Niche CROs are Fragmented

  • Other IVD CROs have to piece together external solutions
  • Many repurpose drug trial tools to manage studies — adding bloat similar to pharma CROs
  • They lack modern technology expertise, an in-house lab, or broad diagnostic experience

Internal Teams Fill the Gaps

  • Internal teams already have enough!
  • They are driving strategy & oversight, on top of internal requirements
  • They’re often left managing trial admin without custom tools
  • Pressed for time, they may rely on sites that are easy to contract with, have brand recognition, or were used in prior studies — not necessarily those with the right patients for the current trial

The Only CRO purpose built for IVD Trials

Led by Assay Validation Scientists

Lara Flores and Dr. Michael Samoszuk, an assay validation scientist and pathologist, respectively, understand how to develop IVDs and how to use them clinically — the perfect combination to bring assays to market.

Trial Technology built for IVD

Our CEO’s technology background led to the creation of Diagnostica™ — a custom CTMS built specifically for IVD trials. With real-time visibility and integrated tools, we run large studies faster, with fewer errors than traditional CROs.

Trial Specific Site Selection — Everytime

RDI uses a data driven approach to email thousands of physicians for each study (using insurance claims data and the latest AI tools combined with our medical expertise) to target sites we know can enroll. Resulting in faster enrollment and better-fit clinical sites

Manage the sample not just the trial

RDI manages every detail — from barcode format and collection tubes to comparator testing and kit logistics. Our team designs and oversees the entire sample workflow to ensure every specimen is valid for analysis and submission-ready. It’s not just GCP compliance — it’s scientific precision, built in.

The RDI advantage:
Integrated execution at IVD pricing without layered vendor chaos

Real Results, Real Stakes

RDI as the Precision CRO

Challenge: Client's study stalled without an instrument with CT values going into fall flu season.

RDI Solution: Found a lab with dedicated Roche 6800 in 2 weeks, leveraged claims data to add sites that enrolled 600 subjects in 2 months, managed logistics and data for the lab and sites through offshore operations.

Outcome: On-time submission with all samples collected and a comparator results (with a CT calibration curve developed with the NIH & Emory)

RDI as the Fast CRO

Challenge: Client required healthy subjects as soon possible as collected samples nearing stability expiration

RDI Solution: Launched a study over Christmas holiday. Activated 10 sites in 3 weeks.


Outcome: RDI sites enrolled 700+ extremely healthy subjects with data locked in 7 months


Our Unfair Advantage

The RDI of today has been 8 years in the making

Diagnosticaâ„¢ Software

  • Combined CTMS, eConsent, EDC, EMR and LIMS
  • Nothing like this exists
  • Unifies site outreach, eConsent, sample tracking, data export & automated payments
  • 21 CFR Part 11 and ICH GCP compliant

Integrated CLIA Lab

  • CLIA & CAP accredited lab
  • 2,000+ sq ft for IVD clinical projects (R&D, marketing, trials)
  • Reference and research testing capabilities
  • Central hub for kit building, sample processing & storage
  • Full suite of cold storage for client samples

Global IVD Team

  • Industry's only purpose-built CRO team for IVD
  • Global staff includes regulatory, assay scientists, Pathologist, PMs & CRAs with significant IVD experience
  • Scalability from offshore support team: GCP trained nurses performing 100% monitoring augmented by AI

Innovation backed by Regulatory and Quality Compliance

RDI has passed FDA & Top IVD QMS Audits

Successfully passed FDA and client audits with zero major findings, demonstrating our commitment to quality and compliance

RDI software is 21 CFR Part 11 compliant

CTMS and all systems are fully 21 CFR Part 11 and GCP compliant—ensuring secure, audit-ready data.

RDI uses QSub and ex-FDA advisors to reduce risk

Regular FDA pre-submissions ensure alignment and reduce submission risk.

RDI uses Advarra IRB for End-to-End Oversight

Comprehensive IRB coverage through Advarra across all studies, including specialized leftover sample protocols

Commercial Models to Fit Your Study

Full-Service CRO

  • Delegate as many sponsor responsibilities to RDI as needed for your trial and submission
  • Transparent, line-item bid grid pricing across all trial activities
  • One point of accountability — hand off execution with confidence

Sample Vendor

  • Engage RDI to acquire samples for R&D or to supplement ongoing studies
  • RDI can act as sponsor and run collection studies on your behalf
  • RDI can collect prospective and remnant samples
  • We manage all compliance and deliver validated samples and data

Standalone Lab Services

  • Engage our lab only (CLIA, CAP, or research model)
  • Ideal for sponsors needing flexible testing services
  • Can conduct reference testing or serve as a clinical site with a PI
  • We also manage send-out testing through Quest and 10+ reference partners

The Management Behind the Trials

Conall Arora

CEO

Built RDI into the go-to CRO for high-stakes diagnostics. With a background in startups and private equity, he fused IVD science with modern systems to deliver faster trials, better data, and confident submissions.

Lara Flores

COO

Lara brings the operational firepower behind RDI’s execution. With prior leadership at NeoGenomics and Beaufort CRO, she’s restructured global lab ops teams, built compliant workflows, and now runs the engine that powers RDI’s trials from sample to data.

Dr. Michael Samoszuk

Chief Medical Officer

Board-certified pathologist and Harvard-trained physician. He brings decades of diagnostic leadership, including past CMO roles at Roche, Ortho-Clinical, and Beckman Coulter. A former UC Irvine professor and published author of 70+ peer-reviewed papers.

Dr. Elisa Romeo

Principal Investigator

A Ph.D. scientist with 20+ years in diagnostics, she’s helped launch dozens of IVD products—securing 510(k), EUA, and CE approvals across cancer, infectious disease, and molecular assays.

Tamara McCaw

Regulatory Affairs

Tamara is a veteran IVD regulatory strategist with over 20 years of experience in diagnostics R&D and regulatory affairs. A chemical engineer by training, she has held senior roles at Abbott and SQI Diagnostics and specializes in FDA and global strategy, Q-submissions, and regulatory pathway design.

Liisa Johns

Quality Assurance

Liisa brings 25+ years of leadership across IVD quality, compliance, and operations—most recently directing quality strategy for Abbott’s global toxicology business. She has built and scaled compliant Quality Management Systems across 17+ global sites, led ISO/IEC 17025 and FDA inspection readiness efforts.

The Team Behind the Trials

Bilal Al-Hamed

Site Relations Manager

Jannette Degadillo

Scientific Proposal Manager

Claire Chenault

IVD - Senior CRA

Katie Barrett

IVD - CRA

RDI Team

Project Managers, CRA and Lab Team

What Can RDI Help You With?

Let’s talk about your biggest challenge—
we’ll bring the right lab, team, and tools to solve it

Contact us:

Conall Arora - conall@rditrials.com
Lara Flores - lara@rditrials.com
Michael Samoszuk - michael@rditrials.com