Clinical Laboratory Consulting

ResearchDx has earned the reputation as the premier provider of  CLIA and accreditation laboratory consulting services, having provided guidance for many industry leading CLIA laboratories.
ResearchDx can provide complete turnkey Clinical Laboratory startup services, or alternatively, we will work with established companies to seamlessly integrate only the components you need into your current framework.

Our Clinical Consulting Services include:

  • CLIA licensure applications and changes
  • CAP and ISO15189 Accreditation licensure applications and changes
  • State-specific (CA, NY, FL etc) licensure applications
  • Provision of contracted Laboratory Directors, and Clinical and Techinical 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 ISO15189 audits
  • CLIA compliant Quality Management  System.
  • Provision of standard laboratory SOP’s
  • Provision of  logs for reagent inventory, temperature, QC and patient testing
  • Guidence and review of Requisitions and Reports
  • General guidance for CPT coding
  • Enrollment in proficiency testing

 

   Our Turn Key CLIA Certification Services include

  • CLIA and Accreditation Compliant Quality Management System
  • Electronic Document Control Sytem
  • Assistance with all requried 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 Acceditations

ResearchDx has extensive experience in navigating international companies through the United States Clinical Laboratory Improvement Amendments (CLIA) international certification process, ISO15189 and College of Pathology (CAP) international accreditation process (where required).
Many pharmaceutical company clinical trials are requiring these internationally recognized standards, and the process is slightly different for international laboratories. To discuss your individual requirements, please email info@researchdx.com, or contact us.

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 Clinical Laboratory
  • A dedicated state of the art Laboratory formation system
  • Access to state o the art equipment and facilities.
  • Dedicated laboratory space
  • A team of Experienced California licensed, and CLIA qualified laboratory technologists.
  • Extensive Bioinformatic capabilities
  • Dedicated phone tree, and client services
  • Customized reporting options available
  • Flexible billing

Company Highlight:

ResearchDx has extensive experience with the validation, clinical implementation of Next-Gen Sequencing technologies in a CLIA approved and CAP accredited environment. Ask us about your options for implementation of your novel Next-Gen sequencing assay in a clinical laboratory.