Seok Joo Lee – CEO, ISU Abxis, South Korea
ISU Abxis, a subsidiary of the ISU conglomerate, is a biotech company with a focus on orphan drugs and rare disease. CEO Seok Joo Lee explains the rationale behind his…
Address: 711, Royal Bldg 5 Dangju-dong, Jongro-gu, Seoul,Republic of Korea
Tel: +82 2 730 1451
Web: http://www.admRepublic of Korea.co.kr/
ADM Inc. is leader in providing full clinical services in Republic of Korea. ADM is a member of EPS group (HQ is located in Tokyo, www.eps.co.jp / www.eps-inter.com). If you consider Asian multi-national clinical study, ADM together with EPS will be the best choice.
Some of the services that we excell on providing are: Regulatory Strategy Consulting Registration Dossier IND Submission Communication with Regulatory Authorities Regulatory Change Reporting Phase I-IV Clinical Trial Project Planning Protocol and CRF Development Investigator Recruitment and Site Selection IRB Submission Investigational Staff Training Clinical Trial Management Monitoring Quality Control Quality Assurance Data Management Statistical Analysis Clinical Trial Report Writing Protocol & CRF Development IRB Submission Investigational Staff Training Project Management Data Collection and Monitoring Data Entry Data Management Statistical Analysis Safety Report Annual and Final Report Writing Data Management Plan Development Customized Database Design & Development Verification and Edits Medical Coding By MedDRA, WHO-ART, KIMs, Etc. Double Data Entry Full Electronic Audit Trail Data Comparison Query Generation and Resolution Data Transfer and Management Statistical Analysis Plan Development Statistical Programming and Validation Statistical Reports Statistical Consulting Project Master Files/ Essential Documents Audits Investigator Site Audits Sponsor Audits System Audits Pre-regulatory Inspection Audits, Including Preparation and Training for the Inspection Protocol Translation Informed Consent Form Translation Clinical Trial Report Translation IB Translation IRB Submission Document Translation All of Clinical Trial Document Translation
ISU Abxis, a subsidiary of the ISU conglomerate, is a biotech company with a focus on orphan drugs and rare disease. CEO Seok Joo Lee explains the rationale behind his…
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