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Pathfactor™



Clinical Trials Department

Our Clinical Trials department has a dedicated team committed to providing a consultative and advisory element to our clients along with accurate, quality results in a timely and professional manner. Our large volume of cytology, biopsy, and clinical specimens helps facilitate rapid accumulation of specialized samples for analysis and correlation to meet specific study requirements. In addition, Pathology, Inc.’s molecular, anatomic pathology,and clinical capabilities provide the versatility needed for trials of various complexity and scope.

Our goal is to provide the testing needs for your trials in an effective and cost-efficient manner. The medical staff of Pathology, Inc. combines a blend of subspecialty expertise with experience in both the outpatient and hospital inpatient venues.

Our laboratory facilities are equipped with state-of-the-art equipment to ensure we are delivering precise and accurate data. Our quality assurance commitment is backed by our accreditation with the College of American Pathologists (CAP) and our systems’ compliance with FDAs 21 CFR Part 11.

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For more information, please contact us at PathfactorInfo@PathologyInc.com



STUDIES

Pharmaceutical Clinical Trials

  • Pre-Clinical/Clinical Studies (any phase)

Medical Device Clinical Trials

  • PMA (clinical validation)
  • 510(k) (analytical validation)

Custom Developed Assays for R&D Studies

ADVANCED TECHNOLOGIES

Molecular

  • Molecular genetics
  • Broad menu of Flowcytometry markers
  • Tumor markers
  • Molecular infectious disease
  • FISH assays
  • Sexually transmitted diseases

Anatomic Pathology

  • Broad menu of 200 IHC markers
  • Clinical Pathology
  • Microbiology
  • Digital Pathology

ACCESS TO CLINICAL SPECIMENS

  • 350,000 Liquid-based Paps annually
  • 75,000 Biopsies annually
  • 60,000 Vaginitis/STD profiles annually
  • Microbiology and molecular swab samples
  • Blood, Urine

EXPERTISE

  • Over 30 years in women’s health
  • 40 Ph.D.s/Board certified pathologists
  • FDA Registered Donor testing for IVF

TECHNOLOGY PLATFORMS

  • Comprehensive molecular platforms
  • Automated clinical chemistry, hematology, immunology, special chemistry
  • Automated Microbiology ID and MIC
  • Automated IHC and cytology
  • Digital imaging and analysis technology

QUALITY

  • Accreditation/Certification/Registration
    • CLIA, CAP, FDA
  • GMP, GLP, GDP compliance
  • Secure key carded area
  • High-quality QA/QC

LOGISTICS

  • National coverage
  • Ten minutes from Los Angeles Int’l Airport

REPORTING

  • 21CFR Part 11 Compliant

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© 2014 Pathology, Inc.