Service Providers
Service Providers
- Name of Company
- 인바이츠바이오코아(주)
- Address
- 서울특별시 금천구 디지털로9길 33 IT미래타워 8층
- Key Services
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- Clinical CRO
- Non-Clinical CRO
- Central Laboratory(Central lab, Bio-analytical lab)
- Bioequivalence study CRO
- Consulting
- Homepage(English)
- http://www.bio-core.com
- Sales(end of 2024)
- NR
- Human Resources Status
- 142
- Number of audit of Regulatory agency(ex FDA/EMA, etc.)
- 1회 이상 ~ 5회 미만
- ISO 9001
- Not Provided
- Status of Additional Certifications
- 비임상시험실시기관 지정서(MFDS), 임상시험검체분석기관 지정서(MFDS)
- Key Strengths
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1. More than 20 years of analysis technology The first CRO based on Bioanalysis in Korea Completed the method validation over 500 compounds Experience over 2,000 of projects Having a high sensitive instruments e.g. LC/MS/MS TQ 7500, TQ 6500+ model 2. Clinical CRO with Labs Protocol Development (having over 300 cases of clinical protocols) Experience of global project management The only one CRO for micro-tracing clinical trial Expand to clinical study such as Phase 2~3, PMS, In vitro diagnostic products, medical device, digital therapeutics
- Introduction Materials (Upload attachment)
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Services Provided by Clinical CROs
- Clinical Operation
- Provided
- Medical Writing
- Provided
- Statistics
- Provided
- Data Management
- Provided
- Regulatory Affairs
- Not Provided
- Pharmacovigilance
- Provided
- Vendor Management
- Provided
- Consulting
- Provided
- Feasibility Service
- Provided
- Medical Monitoring
- Not Provided
- Training and Education
- Not Provided
- IT Solution
- Not Provided
- CDISC data service
- Not Provided
- Project Management
- Provided
Services Provided by Non-Clinical CROs
- GLP toxicity study
- Not Provided
- Safety pharmacology study
- Provided
- Efficacy study
- Not Provided
- Consulting
- Provided
- Toxicokinetics
- Provided
- SEND data service
- Not Provided
- Pharmacokinetics study
- Provided
- Sample analysis
- Provided
- Method Development
- Provided
Services Provided by Central Laboratory
- Sample analysis
- Provided
- Result Analysis/Report
- Provided
- Project Management
- Provided
- Method Development
- Provided
- Sample Management
- Provided
- Logistics
- Not Provided
- Biomarker (incl. Protein) expression analysis
- Provided
- Supporting precision medicine advise
- Not Provided
- Laboratory Kit preparation; packaging; maintenance
- Provided
- Sample kits, supplies, etc. management
- Provided
Bioequivalence CRO
- Bioequivalence CRO
- Provided
Consulting Services
- Consulting
- Provided
- Other
Compliance Certification Status for Domestic and International Data Protection Regulations
- Data Protection Regulation_GDPR
- Not Provided
- Data Protection Regulation_21CFR11
- Provided
- Data Protection Regulation_others