中央实验室服务

- 临床测试研究支持
- 中央实验室服务
C-LAB Services
- 随着医药品的发展日趋世界化,韩国也和美国、欧洲一样,认识到了Central Laboratory (C-LAB)的重要性。
- SCL在全韩国首次开设为开发新药的临床测试专用Central Laboratory (C-LAB),以满足这种需求。
- 使用已验证的检查方法持续进行检查,检查记录将保管到医药品申请批准时为止,或者根据客户的要求在一定期间内保管。
- 杜绝多国、多个机构进行临床检查时可出现的偏差,统一的参考值使结果具备连续性,容易分析。
- 还通过和委托人间的有机合作,升级临床数据的eCRF,进行DM 统计等,使临床测试专用数据的管理更加容易
Experiences in Clinical trials
Years |
Number of Clinical Trials (Cases) |
2006~Present |
Over 500 |
Central Laboratory (C-LAB) Service Proces
Project Management
- Project Management
- A study coordinator, assigned for each contracted project, manages the entire project cycle from the preparation phase to the completion of the project.
Preparation of Specimen
Collection Kit
- Preparation of Specimen Collection Kit
- Specimen collection tubes, instruction manuals, requisition forms, and other necessary materials for a clinical study are packaged into a kit box in compliance with the respective protocal and sent to each sites participating in the clinical study.
Set up / Configuration
- Set up / Configuration
- A study coordinator in charge of the project visits the sites participating in the clinical study to
explain procedures including the preparation of the specimen collection kit and specimen transportation
procedures.
Specimen Transportation
- Specimen Transportation
- SCL is responsible for the transportation of the specimen from the each site participating in the clinical study to SCL Central Laboratory (C-LAB).
Validation & Analysis
- Analysis
- SCL Reference Lab. and Central Laboratory (C-LAB), specialized in clinical studies,
carry out analysis according to test schedules.
Data Report & Transmission
- Result Report & Data Transmission Service
- Using a "SMART" system specially designed for SCL, the Central Laboratory (C-LAB) provides
online services to offer convenience in checking test results directly at each site, while
delivering electronic data that is compatible with the e-CRF to the sponsor and CRO.
Remnant Specimen Storage
- Remnant Specimen Storage
- SCL Central Laboratory (C-LAB) offers remnant specimen storage services and also provides
the specimen shipping services to other organizations (national and international)
according to the specifications in the contract.
Document Archiving
- Data Archiving
- Records and materials created during each project are organized and archived in the Document Archiving Room.