Central Laboratory
Established in 2000, Clinigene’s Central Laboratory offers dedicated laboratory services to clinical trials, research/cohort studies. It is the first laboratory in India to be accredited by CAP (College of American Pathologists). Central Laboratory is an Intercontinental Referral Laboratory for Esoterix Inc., LabCorp, USA. The main areas of specialization are Biochemistry, Hematology, Microbiology, Histopathology and Clinical Pathology.
Quality Credentials
- CAP accreditation since May 2002
- Sponsor audits
Infrastructure
- Facility spread over 8,000 sq. ft.
- Olympus AU 400 (Chemistry Analyzer)
- Roche Modular (Chemistry Analyzer )
- Coulter Hematology Analyzer (LH-500, HMX)
- Tissue processor
- Mini API
- Immulite
- Urisys
Expertise
In-house developed Laboratory Information Management System (LIMS):
- In compliance with 21 CFR part 11, LIMS offers secure and electronic review of Central Laboratory data. The samples are bar-coded to ensure confidentiality and accurate testing.
Logistics:
- Offers high quality and cost effective shipments of clinical trial specimens from any where in the world
- To assure accurate delivery to international sites, we provide IATA certified packaging materials and pre-printed documentation for all types of shipments
- Cool packs for 2-8°C (refrigerated) and dry ice for frozen shipments
Services
- Supports Phase I – IV single centre and multicentric trials
- Safety test requirements for Pilot and Pivotal BA/BE/PK studies
- New assay development
- Sample movement (local and international)
- Study management
- Sample storage
- Diagnostic device validations
- Testing facilities in all disciplines of lab medicine
- Provides laboratory services for global trials
Advantages
- Experienced and highly trained staff
- Study specific and visit specific specimen collection devices and containers
- Customized packaging and transport material for ambient, refrigerated and frozen shipments
- Customized study data delivery according to format specifications of the sponsor
- Clinigene’s LIMS provides the global clients access to
real-time data
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