CENTRAL LAB

SERVICE AND QUALITY DATA WITHOUT COMPROMISES


Pharmaceutical development is evolving rapidly and with it the demand for high-quality laboratory services continues to grow. Coupled with your need to access laboratory/patient data in real time, to make faster decisions about your drug candidate, finding a lab service provider with the required expertise can be challenging.

Biotech, Inc.® Laboratories’ central lab provides standardized testing, consistent results and innovative data solutions across a wide range of technologies and applications for all phases of pharmaceutical development.

AWARD-WINNING PRECLARUS® SOLUTIONS PROVIDE ACCESS TO REAL-TIME LAB DATA FOR INVESTIGATOR SITES, PROJECT TEAMS AND CUSTOMERS THROUGH PORTALS AND DASHBOARDS

Preclarus central lab database

Our innovative enterprise and information management system delivers central lab data in real time to enable better decisions, faster. For studies utilizing Biotech, Inc.’s clinical development and central lab services, data from the Preclarus central lab database can be automatically integrated with patient/medical data from Biotech, Inc.’s clinical trial management system to help you get to database lock faster.

Preclarus investigator site portal

The Preclarus investigator site portal provides intuitive and interactive tools for central lab sites to manage subject enrollment, register samples, manage sample shipments and order collection kits. The electronic lab requisition reduces risk of sample loss by establishing chain of custody before the sample leaves the clinic.
 

Preclarus project management (PM) dashboard

The PM dashboard is a tool for project managers to monitor the non-data aspect of your trial. The dashboard enables project managers to view your trial’s spend rate, manage collection kit inventory, missing samples, site performance and patient enrollment.

Preclarus lab data portal

The Preclarus lab data portal enables you and your clinical team to access and analyze lab results in aggregate so that you can closely track the progress of your trial.

Biotech, Inc. MET OR EXCEEDED DATA QUALITY EXPECTATIONS FOR 97% OF Biotech, Inc.’s USERS. 1

Our locations in Asia, Europe and North America ensure customers have access to central laboratory services, regardless of where study sites are located.

Central-lab-Map

OUR GLOBAL LABORATORY ASSAY STANDARDIZATION SURVEY (GLASS) DRIVES HARMONIZATION AND EFFICIENCY EFFORTS ACROSS LOCATIONS


GLASS promotes a consistent approach to auditing, deviation management and standard operating procedures. It includes standardization processes, instrumentation, calibrators and standard operating procedures (SOPs). It also utilizes weekly check samples to ensure results will be the same regardless of which location performs the testing.

The impacts of the Preclarus central lab database are maximized through GLASS. Results are transmitted directly into the database from our labs without a normalization/standardization step. This provides data to study sites and project teams in real time.

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AT Biotech, Inc. LABORATORIES, WE ARE COMMITTED TO OPERATIONAL EXCELLENCE


Our quality and compliance standards are governed by a global quality manual and GLASS. These processes are built upon the requirements of the:

  • College of American Pathologists (CAP)
  • Clinical Laboratory Improvement Amendments (CLIA)
  • National Glycohemoglobin Standardization Program (NGSP)
  • Quality System Essentials (QSE) as defined by the Clinical and Laboratory Standards Institute (CLSI)