Central Laboratory
Established in 2000, Clinigene Central Laboratory offers laboratory services exclusively for clinical trials, Bioanalytical/Bioequivalence and research/cohort studies. It is the first laboratory in India to be accredited by CAP (College of American Pathologists) and is the Intercontinental Referral Laboratory for Esoterix Inc., LabCorp, USA to support local testing for global studies. The main areas of specialization are Biochemistry, Hematology, Microbiology, Histopathology, Immunohistochemistry and Clinical Pathology.
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
Infrastructure
- Housed in an area of 8000 sq. ft
- High throughput instrumentation capable of 10,000 tests /day
- 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
- 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 with uncompromised accuracy and state-of-the-art infrastructure
- 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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