SCL Seoul Clinical Laboratories

臨床試験研究支援

C-LAB Services

医薬品の発展が世界化につれ、韓国でもアメリカやヨーロッパと同様に、セントラルラボの重要性が益々増しております。SCLは韓国初で新薬開発のための臨床試験専用のセントラルラボを運営し、このような要求に応じています。検証された検査方法で持続的な検査を施行し、検査記録は医薬品の承認申込み時までは勿論、顧客の要求に合わせ一定期間保管します。多国家、多機関で臨床検査を進行する時に現われる偏差を無くし、統一された参考値として結果の連続性及び解釈が容易いです。また、依頼者と有機的な協力で臨床データのeCRFアップロード、DM統計など臨床試験専用のデータ管理を容易く報告しています。

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 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: 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.