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.
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 proprietary and award- winning enterprise and information management system is purposefully designed to manage every aspect of a central lab clinical trial.
Preclarus project management (PM) dashboard
Real-time access for PPD project teams to program, region, site level data (labs results, quality data, budget).
Preclarus investigator site portal
Secure clinical site access to manage study activities (e.g., sample/subject registration, kit supply ordering and query resolution) and provides 24\7 access to real time data for investigators.
Preclarus lab data portal
Secure access for customer project teams to real-time, studywide data including the ability to visualize, organize, search and manage lab data.
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
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.
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)