• 임상 CRO
• 비임상 CRO
• 검체분석기관

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.)