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New drug clinical trials
Central Laboratory
Our Central Laboratory is staffed with specialized testing teams skilled in:
· Virus culture and detection
· Nucleic acid molecular testing
· Bacterial culture and detection
· Immunological assays
The laboratory is CNAS-accredited and operates under a robust quality management system. It is also fully registered as a Biosafety Level 2 (BSL-2) laboratory.
Our experienced team has conducted:
· Strain re-verification and identification for Phase II clinical trials of antibacterial and antiviral drugs
· Adenovirus detection projects
With state-of-the-art facilities and professional expertise, the Central Laboratory ensures reliable, high-quality testing services to support scientific research and drug development.
Service Items
Sample Collection & Consumables
We are committed to providing comprehensive, customized solutions for sample collection, preservation, and transportation in clinical research, ensuring an efficient and smooth research process. Customized Collection Kit Service:
• The sample collection kit is precisely designed according to the research plan, integrating essential components such as sample collection consumables, dedicated labels, recording forms, and operation manuals.
• It provides a convenient, out-of-the-box collection experience, simultaneously completing sample collection and information entry.
High-quality consumable supply chain guarantee:
• Partnering with globally renowned medical suppliers to offer a diverse selection of compliant consumables.
Professional logistics and distribution system:
• Partner with professional medical logistics service providers to cover all transportation needs across ambient temperature and cold chain scenarios
• Ensure the safe and timely delivery of all types of sampling kits and samples to research sites or central laboratories
Strict quality control mechanism:
• Implement batch sampling quality inspection to strictly control the quality of consumables.
• Establish a rapid response mechanism: immediately replace batches with quality issues and promptly reissue missing items.
• Full traceability of supplier collaboration to ensure timely resolution of problems. We provide reliable logistical support for clinical research by combining standardized processes with personalized services.
Cold Chain Transportation
Partnering with professional and efficient cold chain logistics companies provides comprehensive quality assurance for specimens before testing.
Sample Testing
We have built an industry-leading testing and diagnostic technology system, supported by a multidisciplinary technology platform, to provide testing services covering all fields: Core technology platform layout
• Three major high-tech centers: Pathogen Nucleic Acid Detection Center, Virus Isolation and Culture Detection Center, Bacterial Isolation and Culture Detection Center
• Three major technology platforms: Immunofluorescence/Molecular Diagnostics/Bacterial Mass Spectrometry Identification
Project Management
We provide professional project management services covering the entire clinical trial cycle, employing a "three-pronged" management model (comprehensive process, comprehensive elements, and comprehensive personnel) to ensure high-quality project operation: Professional team support
• Experienced project management team with biomedical backgrounds
• Professional liaison with the central laboratory's technical team
Customized service solutions
• Tailor-made specimen management solutions for the entire process (submission → receipt → testing → reporting → storage)
• Provision of standardized service manuals and targeted training guidance
• Flexible response to various special testing needs
Efficient operation guarantee
• Establish a multi-party real-time communication mechanism (sponsor/CRO/research center)
• 24/7 emergency response system
• Comprehensive quality management (personnel/equipment/reagents/samples/data, etc.)
• Strictly adhere to international standards such as GCP, GCLP, and 21 CFR Part 11
Intelligent data delivery supports multiple methods for transmitting test results:
✓ Electronic reports (email/FTP)
✓ Traditional formats (fax/paper)
✓ Customized data integration solutions
We provide reliable central laboratory solutions for clinical research through systematic project management and flexible service adaptation.
Quality Management
We have established an internationally standardized, end-to-end quality management system to provide compliant and reliable technical support for clinical research:
Authoritative Certification System
• The laboratory has obtained international authoritative certifications such as ISO 17025.
• Project management fully complies with GCP, GLP, and GCLP standards.
Six-dimensional quality control: Implementing comprehensive monitoring of "people, machines, materials, methods, environment, and testing".
• Personnel qualifications and operating procedures
• Equipment calibration and maintenance
• Reagent and consumable quality control
• Implementation of standard operating procedures
• Laboratory environmental monitoring
• Standardization of testing processes
Full lifecycle management
• Ensure the integrity and traceability of research data and documents
• Achieve end-to-end quality control from sample collection to test reports
• Establish a comprehensive document recording and preservation system
We provide reliable quality assurance for clinical research through international quality standards and systematic control measures.
Microbiological & Virological Testing
Bacterial Isolation and Identification
Virus Isolation and Culture Detection (ccIFA)
Mycoplasma Culture and Identification (Pharmacopoeia Method)
Pathogen Nucleic Acid Detection (qPCR, ddPCR)
Adeno-associated Virus (AAV) Neutralizing Antibody Assay
Testing Platforms
Digital PCR Detection Platform
Microbial Mass Spectrometry Detection Platform
Immuno-fluorescence Detection Platform
qPCR Detection Platform
Enzyme-Linked Immunosorbent Assay (ELISA) Platform
Contact Information
Xishan Mobile Website
Xishan Official WeChat