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Central Laboratory

Clinigene’s Central Laboratory is one of the most experienced labs in India, which offers laboratory services exclusively for clinical research projects. It is the first laboratory in India to be accredited by CAP (College of American Pathologists). Our central lab is also the Intercontinental Referral Laboratory for LabCorp clinical trials to support local testing for global studies.

The main areas of specialization are Biochemistry, Hematology, Coagulation, Histopathology,  Immunohistochemistry, Flow Cytometry, Clinical Pathology and Biomarkers.

Since December-2011 we are collaborating with Pacific Biomarkers Inc. (PBI) - a market leader in biomarkers for CVS, diabetes and metabolic disorders - to offer novel biomarker development and testing services to drug development community in India.

Quality Credentials

  • CAP accreditation since 2002
  • NABL (National Accreditation Board for Testing and Calibration Laboratories) accreditation [Certificate No: M-0027] since 2003
  • Level II NGSP (National Glycohemoglobin Standardization Program) certification since 2009
  • Certificate of Traceability from Cholesterol Reference Method Laboratory Network

Infrastructure

  • Housed in an area of 8000 sq. ft
  • High throughput state of the art analytical instrumentation
  • Access controlled facility
  • Wireless data logging system for remote control of temperature and humidity
  • Well placed alarm systems
  • Contractual arrangements for biological waste disposal

Expertise

  • Phases I-IV clinical trials
  • BA/BE studies
  • Establishment of new assays and validations to meet client requirements
  • Extensive experience in clinical trial testing in the areas such as, Diabetes, Cardiovascular, Oncology and Immunology

Services

  • Supports Phases I – IV single centre and multicentric trials
  • Safety test requirements for Pilot and Pivotal BA/BE/PK studies
  • New assay development and validation
  • Diagnostic device validations, incl. Biomarkers
  • Global logistics and sample management
  • Project management
  • Kit Building
  • Testing facilities in all disciplines of lab medicine
  • Data management customized to meet the requirements of the sponsors

Advantages

  • Meets Global Standards
  • Internationally accredited facility in compliance with current best standards for medical laboratories
  • LIMS in compliance with CFR 21, Part 11 ensures high standards of data integrity
  • Quality control systems in place through internal QC process and participation in external Proficiency Testing programs
  • Qualified and experienced laboratory personnel and project management teams
  • Value-added services provided: Assay Validation and Development, Consultancy and Training

 

 
     
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