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
  • 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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Services Provided by Clinical CROs
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
Services Provided by Non-Clinical CROs
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
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
Compliance Certification Status for Domestic and International Data Protection Regulations
Data Protection Regulation_GDPR
Provided
Data Protection Regulation_21CFR11
Provided
Data Protection Regulation_others
ISO/IEC 27001(Information Security Management Systems)