Central Lab Test & Services
Tests and Services Available from Our Central Labs
Every Quintiles Central Laboratory delivers excellence using identical processes, instruments, validations procedures, tests and reagents. The global portfolio of tests extends well beyond basic safety testing, is constantly expanding and is bolstered by our Center of Excellence relationships.
Testing Capabilities:
| Biochemistry Hematology Lipid profiles Coagulation studies Diabetic profiles Infectious disease serology Virus antigen detection CDC lipids PCR (real-time and conventional)and branch chain DNA amplification | Flow cytometry assays Auto-immune profiles Inflammatory disease/immune markers Endocrinology testing Drug screening Qualitative and quantitative toxicology Biomarkers – cytokines and growth factors |
Project Management
Project set-up and management by client-dedicated teams QNET web-based laboratory data monitoring system with access 24/7 Global SOPs and core quality standards. Comprehensive customer or protocol-specific monitoring, investigator instruction manuals and training.
Logistics and Sample Management
Pharmacokinetic, genomic and sample management services:
- Short - and long-term specimen storage at -70˚C
- Time point and specimen tracking
- Closely monitored, manifested specimen shipping services
- DNA extraction using the Gentra PureGene™ method
- RNA stabilization and extraction using the Qiagen PaxGene™ method
- Genomic sample banking at -70˚C
- Sponsor Defined processing
- Code Libraries for Industry Standard Extractions & Client File Specification
- Order Entry Files – Including Incremental Updates
- Proactive Comprehensive Edit Checks upon Sample Reception
- Biopsies
Global logistics management:
- Visit-specific specimen supply kits, instructions and laboratory requisitions to ensure appropriate specimen collection and identification
- Express courier shipping to ensure specimen stability
- International Air Transport Association-compliant packaging material and documentation
- Bar code readers for positive specimen identification and tracking every step of the way
- Validity checking for laboratory requisition data to ensure a clean database
- Auto resupply
- Packing Lists
Data Management Data Transmissions
- Protocol Specific Edit Checks prior to Data Transmission
- Flexible collection and reporting standards (CDISC or customized)
- Hands Free Process from Extraction through Transmission to Archival
- Cumulative or Incremental
- Transmissions for CDMS, IVR, Safety Board, etc
- Rigorous Test Transfer and Approval Process
- Detailed File Specifications
- Programming Standards and Validation Life Cycle
- Data Reconciliation and Integrity Checks following Data Extraction
- “Clean As You Go” Processes Reduces Last Minute Changes
- Flexible Schedules and Data Send Frequencies
Data Imports
- 3rd Party Reference Labs & Affiliate Labs
- Data Integrated into QLIMs - - QNET & Single Transmission File
- Automated Data Import through Secure Web Portal
Local Lab Data Management
- Data Entry & Query Resolution by Med Techs
- Proven Process and System Used by Clinical Data Management for Paper Studies
Full Service Integration
- Harmonized Processes with Clinical Data Management
- Single Global Repository for all Patient Data Types
- Standardized Central Query Management
- Web Portal Access (Subject Data Review Tool / CRO Dashboard)
- Early Communication of Expectations and Milestones
Esoteric Data Expertise
- Pharmacogenomics & Biomarkers
- Histopathology & Digital Imaging
- Work Hand in Hand with Assay Development Lab