Service Providers
- Name of Company
- BioInfra co., Ltd
- Address
- (Headquarter) 5 floor, 120 Heungdeokjungang-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea / (Clinical Division) 4 floor, 35, Seolleung-ro 93-gil, Gangnam-gu, Seoul, Republic of Korea
- Key Services
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- Clinical CRO
- Non-Clinical CRO
- Central Laboratory(Central lab, Bio-analytical lab)
- Homepage(English)
- http://www.bioinfrakorea.co.kr/
- Sales(end of 2024)
- NR
- Human Resources Status
- NR
- Number of audit of Regulatory agency(ex FDA/EMA, etc.)
- 1 to 5 times
- ISO 9001
- Provided
- Status of Additional Certifications
- INNOBIZ, Venture Company, KGCLP Institution, ISO Management Systems Standard, ISO/IEC 27001(Information Security Management Systems), ISO 9001(Quality Management Systems), ISO 14001(Environmental Management Systems), ISO 37001(Anti-Bribery Management Systems), ISO 45001(Occupational Safety and Health Management Systems), Computerized System GAMP(Good Automated Manufacturing Practice), LIMS(Lab information Management System), Automated Workstation, Data Processing & Reporting System, DM Platform(CDISC, SEND)
- Key Strengths
-
BioInfra co., Ltd. is a leading Contract Research Organization (CRO) celebrating its 20th anniversary. We provide clinical trial services across Phases I – IV, including bioequivalence studies for pharmaceuticals, medical devices, and health functional foods. Through our key strengths and differentiators outlined below, we strive to deliver the highest level of client satisfaction. • Minimize lead times based on extensive experience • Provide Integrated Consulting for establishing strategies • Provide data and documents in accordance with global standards - Clinical Data in the Form(CDISC) required by FDA (SDTM, ADaM) - eTMF using DIA’s TMF reference model • Securing Korea's Top Analytical Technology and GCLP Reliability - ISR reproducibility of 98% (±10%), exceeding the 67% ISR reproducibility requirement specified in the FDA ICH M10 guideline. - Provides highly sensitive data using Single Molecular Array technology, which offers 100–1,000 times greater sensitivity than conventional ELISA. • Compliant with the 2012 WHO Audit (The Only One in Korea) • Ranked No. 1 in Preference by Global Pharmaceutical Companies • Institution Visited by KFDA Regulatory Officials from Third Worlds (ASEAN, Africa, etc.)
- Introduction Materials (Upload attachment)
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- Clinical Operation
- Provided
- Medical Writing
- Provided
- Statistics
- Provided
- Data Management
- Provided
- Regulatory Affairs
- Provided
- Pharmacovigilance
- Provided
- Vendor Management
- Provided
- Consulting
- Provided
- Feasibility Service
- Provided
- Medical Monitoring
- Provided
- Training and Education
- Not Provided
- IT Solution
- Not Provided
- CDISC data service
- Provided
- Project Management
- Provided
- GLP toxicity study
- Not Provided
- Safety pharmacology study
- Not Provided
- Efficacy study
- Not Provided
- Consulting
- Not Provided
- Toxicokinetics
- Provided
- SEND data service
- Not Provided
- Pharmacokinetics study
- Not Provided
- Sample analysis
- Not Provided
- Method Development
- Not Provided
- 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
- Data Protection Regulation_GDPR
- Provided
- Data Protection Regulation_21CFR11
- Provided
- Data Protection Regulation_others
- ISO/IEC 27001(Information Security Management Systems)