Service Providers
Service Providers
- Name of Company
- GCCL
- Address
- 4F, 15 Yonggu-daero 2469beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea
- Key Services
-
- Clinical CRO
- Central Laboratory(Central lab, Bio-analytical lab)
- Clinical Solution
- Consulting
- Decentralized Clinical Trial(DCT)
- Logistics/Customs Clearance
- Homepage(English)
- https://eng.gccl.co.kr/
- Sales(end of 2024)
- NR
- Human Resources Status
- 106
- Number of audit of Regulatory agency(ex FDA/EMA, etc.)
- 1-5 inspections over 3 years
- ISO 9001
- Not Provided
- Status of Additional Certifications
- GCLP, ISO15189, CAP, NGSP, ISBER, EQA
- Key Strengths
-
GCCL is a GCLP-certified Lab CRO providing integrated clinical analysis and data operation solutions across the full clinical development lifecycle, from Phase 1 to Phase 4. As a Lab CRO, GCCL combines CRO-level clinical execution with a laboratory-centered analytical platform, enabling consistent, high-quality data management and efficient decision-making in global and multinational clinical trials. - End-to-end Lab CRO platform covering the full clinical development lifecycle - Laboratory-driven,m data-centric CRO execution - Proven experience in global and multinational clinical trials - Strategic analytical support from planning to quality management - Partnership-based delivery focused on clinical success
- Introduction Materials (Upload attachment)
Services Provided by Clinical CROs
- Clinical Operation
- Not Provided
- Medical Writing
- Not Provided
- Statistics
- Provided
- Data Management
- Provided
- Regulatory Affairs
- Provided
- Pharmacovigilance
- Not Provided
- Vendor Management
- Provided
- Consulting
- Provided
- Feasibility Service
- Provided
- Medical Monitoring
- Not Provided
- Training and Education
- Provided
- IT Solution
- Provided
- CDISC data service
- Not Provided
- Project Management
- Provided
Services Provided by Central Laboratory
- Sample analysis
- Provided
- Result Analysis/Report
- Provided
- Project Management
- Provided
- Method Development
- Provided
- Sample Management
- Provided
- Logistics
- Provided
- Biomarker (incl. Protein) expression analysis
- Provided
- Supporting precision medicine advise
- Provided
- Laboratory Kit preparation; packaging; maintenance
- Provided
- Sample kits, supplies, etc. management
- Provided
Clinical Solution Services
- Biostatistics
- Provided
- eCRF
- Provided
- E-Consent
- Provided
- ePRO/eCOA
- Not Provided
- EDC
- Provided
- CTMS
- Provided
- eSafety
- Not Provided
- IWRS
- Provided
- e-TMF
- Not Provided
- Virtual Data Monitoring
- Provided
- Other
- Clinical development consulting, Licensing
DCT Services (Decentralized Clinical Trials)
- Online Subject Recruitment
- Not Provided
- E-Consent
- Not Provided
- IP (Investigational Product) Delivery
- Not Provided
- Remote Study (Remote Monitoring & Telemedicine)
- Not Provided
- In-home Research (Home Visits to the Subject’s Residence for Specimen Collection Including Blood Collection and Vital Sign Assessment)
- Not Provided
- Off-site Data Collection – Self-Collection of Specimens (e.g., Personal Diagnostic Kits)
- Provided
- Off-site Data Collection – Self-Measured Health Data (e.g., Personal Health Management Products, Wearable Devices, Medication Adherence Tools)
- Provided
- Cardiovascular Disease (CVD)
- Not Provided
- Diabetes / Endocrine Disorders
- Not Provided
- Respiratory Diseases
- Not Provided
- Sleep Disorders / Sleep Apnea
- Not Provided
- Obesity / Metabolic Syndrome
- Not Provided
- Medication Management (Electronic Pill Bottle, Recording Medication Intake, etc.)
- Not Provided
- Off-site data collection – self-report(ePRO/eCOA)
- Not Provided
- Remote Data Monitoring
- Provided
- Other
Logistics and Customs Services
- Pharmaceutical Logistics Services
- Provided
- Cold Chain Services
- Provided
- Drug Storage Service
- Provided
- Drug Return and Destruction
- Not Provided
- Shipment Tracking Service
- Provided
- GMP Depot
- Not Provided
- Express Delivery Service
- Provided
- Customs Clearance Service
- Provided
- Other
- CDMO consulting
Consulting Services
- Consulting
- Provided
Compliance Certification Status for Domestic and International Data Protection Regulations
- Data Protection Regulation_GDPR
- Provided
- Data Protection Regulation_21CFR11
- Provided