Clinical Laboratory Consulting

Leaders in Clinical Laboratory Consulting Services

At ResearchDx, our Clinical Laboratory Consulting Division has earned a reputation as the premier provider of CLIA accreditation laboratory consulting services, providing guidance for many industry-leading CLIA laboratories. We deliver complete turnkey clinical laboratory startup services and work with established companies to seamlessly integrate only the components needed for your current framework.

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

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

FDA Signals Major Shift for LDTs

Future proof your Lab from the upcoming CLIA – FDA regulations

On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the Proposed Rule). Under the Proposed Rule, FDA would modify the definition of “in vitro diagnostic products” (IVDs) in 21 CFR Part 809.3(a) stating that IVDs are considered Medical Devices under the Food, Drug and Cosmetic Act (FDCA), “ including when the manufacturer of these products is a laboratory.”

In preparation for this new rule, ResearchDx is provide the following services in anticipation of the new CLIA regulations

Cost effective GMP/ISO13485-Grade reagents and controls: We can custom manufacture, qualify and provide a COA for many reagents and Control materials

Full Kit manufacturing capability: We can design, manufacture, qualify and provide a COA for GMP/ISO13485-Grade diagnostic kit for assays already being performed as LDT’s in your laboratory for your organizations exclusive use.

Turn-Key Site Specific 510(k) and Site specific PMA Consulting: We can provide full consulting services, and provide assistance with documentation for all analytical and clinical studies required for submission.

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

International Licensure and 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.

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.