Clinical Laboratory Consulting

Leaders in Clinical Laboratory Consulting Services

At ResearchDx, our Clinical Laboratory Consulting Division has earned a reputation as a premier partner for CLIA-licensed and CAP-accredited laboratories nationwide. Whether you’re launching a new laboratory, transitioning an assay from research to clinical use, or preparing for your next inspection, our team brings decades of combined regulatory, technical, and operational expertise to every engagement. We deliver complete turnkey clinical laboratory startup services for organizations building from the ground up, and we work just as effectively alongside established laboratories — integrating only the specific components your current framework needs, without disrupting what’s already working.

Why Partner With ResearchDx

  • Decades of combined experience across CLIA, CAP, ISO 15189, and FDA regulatory frameworks
  • A track record supporting laboratories through initial licensure, expansions, and complex deficiency remediation
  • In-house scientific and bioinformatics depth — we understand the assays we help you commercialize, not just the paperwork behind them
  • Flexible engagement models: full turnkey buildout, interim staffing, or targeted project support
  • A single point of contact who coordinates regulatory, technical, and quality workstreams so nothing falls through the cracks

Who We Serve

  • Diagnostic laboratories launching a new CLIA-certified facility or expanding test menus
  • Biopharma and biotech companies developing companion diagnostics or LDTs that require a compliant clinical lab pathway
  • International laboratories and diagnostics companies seeking U.S. market entry through CLIA/CAP pathways
  • Academic and research institutions transitioning research-use assays into a clinical testing environment

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Our Clinical Laboratory Consulting Services

  • CLIA licensure applications and changes
  • CAP and ISO 15189 certification licensure applications and changes
  • State-specific (CA, NY, FL, etc) licensure applications
  • Provision of contracted Laboratory Directors, and Clinical and Technical Consultants
  • Evaluation of laboratory director, clinical / technical consultant, and personnel qualifications
  • Mock CLIA and accreditation inspections, and GAP analysis
  • Responses to CLIA standard and condition level deficiencies
  • Responses to CAP and ISO 15189 audits
  • CLIA compliant Quality Management  System.
  • Provision of standard laboratory SOP’s
  • Provision of  logs for reagent inventory, temperature, QC, and patient testing
  • Guidance and review of requisitions and reports
  • General guidance for CPT coding
  • Enrollment in proficiency testing

Our Turnkey CLIA Certification Services

  • CLIA certification
  • Compliant Quality Management System
  • Electronic Document Control System
  • Assistance with all required clinical laboratory forms and templates
  • Expert guidance on technical SOP content
  • Assistance with initial assay validation and verification
  • Initial onsite audit, progress visits, pre-inspection mock audit
  • Inspection day guidance and assistance
  • Post-inspection deficiency correction
  • Interim Laboratory Director as needed.
  • Post licensure/accreditation quality management review and follow-up

Virtual Clinical Laboratory

Host your assay in our clinical laboratory. Custom and esoteric assays are our specialty! Our virtual clinical laboratory services include:

  • A fully CLIA licensed and CAP accredited molecular clinical laboratory
  • A dedicated state-of-the-art laboratory information system
  • Access to state-of-the-art equipment and facilities.
  • Dedicated laboratory space
  • A team of experienced California licensed, CLIA-qualified laboratory technologists
  • Extensive bioinformatics capabilities
  • Dedicated phone tree and client services
  • Customized reporting options available
  • Flexible billing

International Licensure & Accreditations

With extensive experience in licensure and accreditation, ResearchDx assists international companies to navigate through the international certification and accreditation requirements for the United States Clinical Laboratory Improvement Amendments (CLIA) international certification process and the College of American Pathology (CAP), respectively, where required. We also offer consulting services related to the ISO 15189 certification process.

Many pharmaceutical company clinical trials are requiring these internationally recognized standards, and the process is slightly different for international laboratories.

At ResearchDx, we are proud to uphold the standards of the federal government and use Good Laboratory Practices throughout the entire process. This ensures that our results are as accurate as possible without sacrificing speed, and promotes our commitment to our clients and their patients. We can provide complete support for comprehensive startup services, or work with our client’s existing systems and integrate only the components needed for licensure and accreditation.

CLIA (federal)

CAP

NYS Department of Health

FDA (current, accurate framing)

ISO 15189

Every laboratory’s path to compliance looks different. Whether you need full turnkey support or a targeted consultation on a single deficiency response, our team is ready to build the right scope for your organization. 

FDA: What's Changed, and Whats stayed the same!

LDT Regulatory Landscape: What’s Changed, and Why CLIA/CAP Still Lead

In 2024, the FDA finalized a rule asserting authority to regulate laboratory-developed tests (LDTs) as medical devices. That rule was vacated by a federal court in March 2025, and the FDA formally rescinded it in September 2025 — restoring the traditional regulatory framework in which LDTs are governed by CLIA and, where applicable, state programs like New York’s CLEP, rather than FDA premarket review.

What this means for your laboratory: CLIA certification, CAP accreditation, and (for laboratories serving New York) CLEP approval remain the governing compliance pathways for LDTs. There is no current FDA premarket submission requirement for tests developed and performed within a single CLIA-certified laboratory. ResearchDx’s core consulting services — CLIA licensure, CAP/ISO 15189 accreditation, and validation support — are exactly the pathway your laboratory needs today.

When FDA involvement still matters: Some organizations pursue FDA clearance or approval voluntarily — for competitive differentiation, to support reimbursement discussions, to enable broader commercial distribution beyond the single-lab LDT model (i.e., converting an LDT into a distributable IVD kit), or to commercialize a Companion Diagnostic. ResearchDx supports that path as well, including:

  • FDA Pre-Submission strategy and engagement
  • 510(k) and PMA submission consulting for organizations choosing to commercialize a test as a distributed IVD
  • GMP/ISO 13485-compliant kit design, manufacturing, and Certificate of Analysis (COA) support for labs converting an LDT into a manufactured product
  • Full 21 CFR Part 820 Quality Management System consulting
  • NY State DOH (CLEP) submission support for laboratories serving New York patients
ResearchDx has extensive experience with the validation and clinical implementation of Next-Generation Sequencing technologies (NGS) in a CLIA-certified, CAP-accredited environment. We provide implementation services for novel NGS assays for qualified laboratories.
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