Centrel Reference Lab

Clinical Laboratory

Our Clinical Laboratory is a College of American Pathologists (CAP) accredited state-of-the-art laboratory providing clinical laboratory services to Phase I, Bioavailability/Bioequivalence (BA/BE) studies as well as Phase II-IV clinical trials. CAP accreditation is a testimony to its impeccable and consistent quality.

The laboratory is currently enrolled with CAP and Bio-Rad for external proficiency testing. The laboratory has stringent quality control programs in place and is strictly compliant with all applicable regulations.

Cliantha’s clinical laboratory offers Central Laboratory Services to support the needs of drug development for all Phases of clinical development. Our service capabilities extend to support Multinational and/or MultiCenter Clinical Trials with sites in India as well as in other countries.

Services offered

Our Clinical Laboratory in Ahmedabad is equipped with the state-of-the-art technology to ensure that we deliver precise and accurate laboratory results within the shortest possible turnaround time. The laboratory provides a range of comprehensive services including customized specimen transfer kits, customized test requisition forms, protocol specific collection manuals, and bar-coding of samples. The laboratory also has the capability of long-term specimen archival with complete identity protection and audit trail at each and every step.

  • All facilities compliant with CAP standards.
  • Fully implemented GCLP Practices.
  • Stringent internal quality control.
  • External Proficiency Testing Program from CAP and BIO-RAD.
  • Total Quality Management System.
  • An automated system from bar coding to bi-lateral interfacing of results to minimize any kind of clerical error.
  • Training of investigators at clinical trial sites through customized power point presentations demonstrating venipuncture, sample labeling and packaging.
Quality Assurance

The Clinical Laboratory has been providing Central Laboratory Services for supporting clinical trials that meets or exceeds the regulatory standards for our Sponsors.

We have a highly qualified and trained Quality Assurance Team in place who understand the importance and need to generate accurate laboratory results which is the key in maintaining the integrity of the research project.

Competent Staff

Cliantha Research Limited strongly believes that even in this era of rapid advancements in technology, automation and robotics, the person behind the instrument is more important than the instrument itself. This is especially true when it comes to laboratory data reporting and supervision of laboratory functions. A highly qualified committed team with extensive laboratory experience ensures our commitment to high standards of quality.

Laboratory Information Management System

The Cliantha Clinical Laboratory has a state-of-the-art Centralized Laboratory Information Management System.

All instruments have been interfaced bi-directionally or uni-directionally depending on the analyzer's capability for better accuracy and faster reporting.

Equipment and Capabilities
  • Bar Coding of each sample
  • Compact high performance 5- Part differential hematology analyzer
  • Fully automated discreet, random access, microprocessor controlled integrated Chemistry System
  • Fully automated discreet, random access, microprocessor controlled integrated Chemistry System
  • Fully automated coagulation analyzer
  • Flow Cytometry
  • Direct interfacing of the instrument with LIMS with no manual intervention

As much as possible, equipment-specific reference ranges are established in-house while validating any new test parameter.

Accreditations
  • Clinical Laboratory at Ahmedabad and the clinical lab at Vadodara are accredited by the College of American Pathologists (CAP).
  • Facilities adhere to the principles of GCLP.
Logistics Network
  • We have an efficient logistics network with contracted national couriers for sample pickups.
  • Critical factors like maintenance of temperature are ensured during transport through specialized temperature data loggers.
Web based review

The laboratory deploys a Web Based Report Viewer which is a highly secure web-based tool enabling real-time review of laboratory reports in PDF format, which can be printed or saved for future reference. The security includes unique username and password generation to control viewing specific reports.

Laboratory reports are uploaded to our website on a real time basis, thus reducing the time of report delivery by other means.

Regulatory Inspections

Last Inspection in Nov 2015
Inspected facility in Nov 2006
Inspected facility in Jan 2009
Last inspection in Apr-May 2016
Inspected facility in Feb - Mar 2013
Last inspection in March 2013
Inspected facility in July 2013
Last inspected by Ministry of Health of Turkey in April 2013
Last inspection in Apr-May 2016