PPD® Laboratories’ central lab provides high-quality testing, results and data across a wide range of technologies and applications for all phases of pharmaceutical development. With standardized instrumentation, calibrators and reporting mechanisms, our locations in Asia (Singapore and Shanghai, China), Europe (Brussels, Belgium) and North America (Highland Heights, Kentucky) ensure clients have access to central laboratory services regardless of where study sites are located.
The Preclarus® central lab database, is our innovative enterprise and information management system that delivers central lab data in real time. For studies utilizing PPD for clinical development and central lab services, data from the Preclarus central lab database can be automatically integrated with patient/medical data from PPD’s clinical trial management system. Visibility to integrated clinical and lab data allows for faster patient enrollment, more informed decision-making and faster response to critical values and adverse events.
Central lab investigator sites, project teams and clients can view the data in the Preclarus central lab database through portals and dashboards. The Preclarus investigator site portal provides intuitive and interactive tools for central lab sites to manage subject enrollment, accession samples, manage sample shipments and order collection kits.
The Preclarus lab data portal enables the clinical team to access and analyze lab results in aggregate. In addition, several dashboards, which summarize trial data and metrics, are also available to the PPD Laboratories project team.
Commitment to Quality
At PPD Laboratories’ central lab, our quality and compliance standards are governed by a global quality manual and GLASS (Global Laboratory Assay Standardization Survey). These processes are built upon the requirements of the College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA), National Glycohemoglobin Standardization Program (NGSP) and the Quality System Essentials (QSE) as defined by the Clinical and Laboratory Standards Institute (CLSI). Our quality manual drives harmonization and efficiency efforts across the various locations and promotes a consistent approach to auditing, deviation management and standard operating procedures.
GLASS includes standardized processes, instrumentation, calibrators and standard operating procedures (SOPs) and utilizes weekly check samples to ensure results will be the same regardless of which location performs the testing. In addition, GLASS allows us to maximize the impact of the Preclarus central lab database. GLASS enables our labs to transmit results directly into the database without a normalization/standardization step. This provides data to study sites and project teams in real time.
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