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 provides global standardized testing, consistent results and innovative data solutions across a wide range of technologies and applications for all phases of pharmaceutical development.
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
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 PPD’s 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 to help you get to database lock faster.
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 investigator site portal
The Preclarus investigator site portal provides intuitive and interactive tools for central lab sites to management 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 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.
PPD MET OR EXCEEDED DATA QUALITY EXPECTATIONS FOR 97% OF PPD’S USERS1
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
OUR LOCATIONS IN ASIA, EUROPE AND NORTH AMERICA ENSURE CUSTOMERS HAVE ACCESS TO CENTRAL LABORATORY SERVICES, REGARDLESS OF WHERE STUDY SITES ARE LOCATED
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
Equipment and Assays
Training program competency
Quality Control Program
CAP proficiency testing
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)