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Central Laboratory


Operational since 1996, The Central Laboratory at DiagnoSearch Life Sciences is one of the first Central Laboratories in India. Headed by Dr. Manisha Ginde, MD, it is driven by quality and is dedicated to Phase I through Phase IV clinical research across a broad range of therapeutic areas. Over time, it has supported trials across a wide geographical expanse globally and within India. Beyond standard laboratory risks the laboratory is also geared to detect data risks in real time as its database is integrated with the review platform at DiagnoSearch Wide-Angle-Data.


Accreditations and Certifications


  • College of American Pathologists (CAP)

  • National Accreditation Board for Testing and Calibration Laboratories (NABL) as per ISO15189

  • National Glycohemoglobin Standardization Program (NGSP) Level I

  • Center for Disease Control (CDC) Lipid Standardization Program

 

 

A Strong Quality Base


The Laboratorys Quality Management System follows a consistent approach to Standard Operating Procedures (SOPs). The Laboratory processes built upon its accreditation standards and guidelines are reinforced by ensuring adherence to additional international guidelines and standards such as Good Clinical Laboratory Practices (GCLP), Clinical and Laboratory Standards Institute (CLSI) and European Medicine Agency (EMA) standards to make its operations compliant to global regulatory requirements.

Additionally, the Laboratory routinely participates in a broad range of proficiency programs and follows robust method validation protocols to ensure that the results are always accurate. The Laboratory also adopts multiple quality indicators to monitor and continuously improve laboratory performance.

Comprehensive Testing Menu


Utilization of global standard operating procedures uniform instruments, reagents and analytical methods for laboratory testing enable us harmonize with other laboratories resulting in global laboratory data for submission to health authorities worldwide. Our laboratory instruments are interfaced with the Laboratory Information System (LIS) to ensure timely and accurate result reporting. 

Our testing menu offers:

  • Standard Safety Testing extending to urine Drugs of Abuse

  • Efficacy Analysis for parameters from hormones, tumor markers, infectious disease markers and others

  • Therapeutic Drugs Testing

  • Biomarkers

  • Microbiology

We can also set up and validate additional tests based on the protocol specific requirements.

Laboratory Project Management


Every clinical study is undertaken as a project with a dedicated Laboratory Project Management Team. The Laboratory Project Management Team has a comprehensive background in Clinical Trial Management and Central Laboratory Operations. Acting as the liaison between other study stakeholders, this Team assesses potential risks prior to the beginning of a study and maintains transparency throughout the entire study, assuring accuracy and timeliness in the reporting of results. Customization is the key for project implementation by the Laboratory. The role of the Laboratory Project Management Team is inclusive of, but not limited to, the following:

  • Identification of potential study risks and plan strategies for its mitigation

  • Conceptualization and execution of the site training program

  • Maintain robust, effective and efficient communication flow between all project stakeholders 

  • Consultation for laboratory related regulatory requirements

  • Laboratory supply management

  • Logistics support and management – Domestic and International

  • Regular tracking of project progression using in-built customized tracking tools

Kit and Logistics Management


  • Customized pre-barcoded kits to facilitate complete audit trail

  • International Air Transport Association (IATA) compliant packaging

  • Auditable tracking systems for kit and logistics processes

  • Efficient kit inventory management, expiry tracking and automated triggers for re-supply of kits

  • Logistics set-up: National and International; Ambient, Refrigerated or Frozen

  • Shipment tracking so your precious samples are “Never Out of Our Sight”

Specimen Management


  • In-house sample storage facility

  • Inventory Management for samples stored at sites

  • Data reconciliation and long term sample storage

  • Database provision to sites for sample inventory management

Result and Data Management


  • Laboratory Information System (LIS) and Laboratory Information Management System (LIMS) for complete automation in result reporting

  • Result transmission using secure email

  • Web-based data portal to view results on a real-time basis

  • Data transfers as per client specifications and formats

  • Data Integration with Wide-Angle-Data for Integrated Data review and Risk Management

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