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财团简介

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.