Interview with Sang Goo Shin, President, Korea National Enterprise for Clinical…
Korea had a late start, but is now one of the global hot spots for clinical trials. How would you sum up and explain this quick evolution? Clinical trials in…
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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
Korea had a late start, but is now one of the global hot spots for clinical trials. How would you sum up and explain this quick evolution? Clinical trials in…
You have been in South Korea for several months, following some time as Merck’s President in Pakistan. In your opinion, what do you find as the most interesting aspects of…
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Since KRPIA’s creation in 1999, what would you say have been its main achievements in the South Korean pharmaceutical landscape? KRPIA’s foremost achievement during its existence has been its contribution…
What was the vision behind the creation of the Korea Drug Research Association and its main role in the pharmaceutical sector? Until the middle of the 1980s when Korea Drug…
Could you briefly introduce VGX International to our readers, and in particular explain its relation to US-based company VGX Pharmaceutical (VGXP)? The backbone of VGXP is the University of Pennsylvania…
You have been in S. Korea for a little over a year, following international assignments in Vietnam and Thailand. Besides the fact that this is a much bigger market, what…
You have been working in the CRM industry, particularly with pharmaceutical companies, for more then 10 years. Could you briefly introduce to our readers how the CRM industry has evolved…
Already an economic powerhouse thriving on export-driven industries such as electronics, automotive and ship-building, South Korea is now looking to boost its potential in the life sciences and to…
Over the last several years we have seen a shift in clinical research from traditional healthcare markets to Asia. How do you see this trend evolving in the coming years?…
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