PPD® Laboratory Services Central Lab
SERVICE AND QUALITY DATA WITHOUT COMPROMISES
Pharmaceutical development is evolving rapidly, and with it, the demand for high-quality centralized laboratory services continues to grow. Coupled with your need to access laboratory/patient data in real time and to make faster decisions about your drug candidate, finding a lab service provider with the required expertise can be challenging.
Our Central Lab is dedicated to helping our customers make more informed decisions faster about their clinical trials through our award winning drug development database solution, globally standardized clinical testing and centralized data visibility.
Learn more about our Central Lab from the experts on our blog >
The AWARD-WINNING PRECLARUS® SOLUTIONS PROVIDE ACCESS TO REAL-TIME LABoratory DATA FOR INVESTIGATOR SITES, PROJECT TEAMs AND Customers THROUGH easy to navigate PORTALS AND DASHBOARDS
DATA THAT ENABLES BETTER
AND FASTER DECISIONS
Nearly 70% of the data for a new drug application (NDA) comes from the laboratory. Thorough data creates a clear swift pathway to regulatory approval that is paved with actionable insights. PPD Laboratory services exceeded data quality expectations for 97% of users.1
We support customers’ programs where they need us, and when they need and with four wholly owned laboratories in the U.S., Europe, Singapore, and China, which maintain a robust roster of accreditations.
PPD LABORATORY SERVICES SUZHOU LAB TOUR
Our global laboratory assay standardization survey (GLASS) drives harmonization and efficiency efforts across all study 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 recurring analysis of 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.
GLASS: MONTHLY CHECK SAMPLES ENSURE RESULT STANDARDIZATION
- IQ/QQ/PQ
- Maintenance/calibration
- Assay validation
- Reagent management
- Training program competency
- Management
- Professional development
- CAP proficiency testing
- Univariates
- QC samples
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 Systems Essentials (QSE) as defined by the Clinical and Laboratory Standards Institute (CLSI)
Related Resources
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