Clinical Trials
As an MFDS-designated GCLP facility, we provide prompt and systematic analytical services from initial inquiry to final reporting and study close-out.
Backed by diverse method validation experience and customized service delivery, our RVDS empowers sponsors with the integrated management of sample logistics and real-time project updates.
We provide comprehensive analytical services to support clinical trial safety and efficacy assessments.
Deliver accurate and reliable results leveraging diverse analytical platforms, including PBMC isolation, biomarker analysis, LC-MS/MS, qPCR, and clinical laboratory testing.
A dedicated Project Manager (PM) is assigned to each study and provides tailored services to the specific protocol.
Providing study-specific, customized management for every stage of clinical trials—from lab manual development and lab kit design to site training and result reporting.
Access real-time analytical results and customized electronic data through our proprietary web-based RVDS platform.
Providing real-time tracking of analytical results via web-based RVDS and delivering customized electronic data to streamline efficient data management.
We provide secure storage and management of clinical samples and cells under optimal environmental conditions.
Safely storing and managing temporary specimens and cells under tailored temperature conditions—from ambient and refrigerated to frozen and LN2, and supporting secure domestic and international biologistics.
Operating a quality assurance system in compliance with GCLP (Good Clinical Laboratory Practice) standards.
Ensuring data accuracy and reliability through systematic quality control and validation across the entire clinical trial analysis process.
WORK FLOW
- CDA Execution
- Comprehensive understanding of each project
- Consultation on Analytical Methods and Test Items
- Quotation Preparation
- Contract Execution
- Assignment of Dedicated Personnel for Each Study
- Preparation of Lab Manual
- Lab Kit Preparation
- Project Operation
- Biologistics
- Sample Information Registration and Management
- Method Development and Validation
- Delivery of Analytical Plans/Reports
- Result Reporting through RVDS
- EDC Data Transfer
- Residue sample management
- Document Archiving
- CDA Execution
- Comprehensive understanding of each project
- Consultation on Analytical Methods and Test Items
- Quotation Preparation
- Contract Execution
- Assignment of Dedicated Personnel for Each Study
- Preparation of Lab Manual
- Lab Kit Preparation
- Project Operation
- Biologistics
- Sample Information Registration and Management
- Method Development and Validation
- Delivery of Analytical Plans/Reports
- Result Reporting through RVDS
- EDC Data Transfer
- Residue sample management
- Document Archiving