As a leading commercial clinical laboratory in China, KingMed is accredited by CAP (13 disciplines), ISO15189, ISO/IEC17025, ISO9001, NGSP Level 1 Laboratory, and follows GLP, US 21 CFR Part 11, ICH-GCP and other applicable laws and regulations. We provide comprehensive laboratory services including clinical diagnostic tests, clinical trial central laboratory service, medical research and development center, and food & hygiene tests. With its remarkable degree of advanced technology and research capabilities, KingMed is currently able to provide nearly 1,700 clinical test items, ranging from regular tests to esoteric tests. Through our nationwide network of 19 primary laboratories located in the provincial capital cities, KingMed provides diagnostic tests and information services for clinics, hospitals, international pharmaceutical companies, CROs and biotech companies.
Central Laboratory KingMed Clinical Trial (KMCT) provides comprehensive and customized central laboratory services with broad-spectrum test menu, a team dedicated to Laboratory testing, resulting and reporting in compliance with CAP, ISO15189 standards and other applicable law and regulations. Central laboratory participates CAP and Chinese NCCLS continuing education projects and PT activities timely to ensure accurate results. 13 scientific disciplines are accredited by CAP, including Chemistry, Hematology, Microbiology, Immunology, Endocrinology, Genetics, Molecular Pathology and Anatomic pathology (Histopathology & Cytopathology)
Routine tests Specialty & Esoteric testscovering:
Biomarker development service
Digital Imaging Solution
Hematopathology Genetic Pathology Solution
Personalized Medicine
Pharmacokinetics and pharmacogenomics.
Method development, validation and comparison.
Project Management A dedicated professional team to support central laboratory services for clinical trials. Powerful expert resources to provide supports and consultations.
Project management teams are located both in Shanghai and Guangzhou, All procedures are guided by KingMed Diagnostics Standard Operating Procedures.
Our key professionals: Account Manager: Serves as the primary client contact for global trials and oversees all aspects of the studies.
Project Specialist: Daily monitoring of the laboratory testing and result reporting, working closely with site sponsor monitors or clinical research associates
Data Manager: Perform data transmission and documenting the data transmittal process requirements
Kit Manager: Design customized sample collection kits and arranges distribution.
Client Response Centers: Primary contact for investigator sites
Logistics Preferred, cost-effective and flexible courier arrangements
Comprehensive network of reliable specialized couriers.
Pre-printed, easy to access shipping documents.
Ambient, refrigerated, frozen and combination shipments.
Investigator on-site sample collecting training and kits distribution.
** KingMed Logistics service covers more than 50% of China areas geographically, almost 100% of economically developed regions, near 90% of Chinese populations, serves more than 10000 medical institutes and world well known pharmaceutical companies
Sample Collection Kit Customized sample collection kit service
Kits are pre-packaged by patient visit with unique identification of protocol, instructions for collection, packing and shipment.
Quick response to extra sample collection and reorder .
Customized Requisition form with unique barcode.
Customized laboratory Manual.
Sample Management Full aliquoting and specimen management services.
Sophisticated computerized frozen storage system.
24/7 monitoring and alert systems for all storage facilities with limited authorized access
Long-term storage available.
Data Transfer Fully Validated LIMS (21 CFR part 11 compliant)
Comprehensive Disaster recovery plan
Customized electronic data transfer (ASCII, CT, CDISC, HL7, FTP, to IVRS)
Cumulative or incremental
Frequency as requested