Reclaiming Asia’s Genomic Destiny
The completion of the Human Genome Project (HGP) in April 2003 with the publication of the first human genome sequence is probably one of the most significant landmarks in humanity’s…
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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
The completion of the Human Genome Project (HGP) in April 2003 with the publication of the first human genome sequence is probably one of the most significant landmarks in humanity’s…
Dr Jeong-Sun Seo, chairman of Macrogen & president of the Korea Biotechnology Industry Organization (KoreaBIO), explains the basis for Korea’s success in combating the spread of COVID-19, casts light on…
Gencurix was the first Asian company to develop a prognostic diagnostic test for breast cancer. Its CEO, Dr Sangrae Cho, discusses the importance of creating a test tailored to Asian…
Yeul-Hong Kim, Director of K-MASTER details the project’s success in creating a shared database of genomic data for Korean oncology professionals. Kim also explains the importance of collaboration with Big…
Korean biosimilar firm Celltrion’s USD 266 million acquisition of Japanese outfit Takeda assets in the Asia-Pacific region marks a significant moment in Celltrion’s international expansion as well as yet another…
Under the stewardship of regenerative medicine industry veteran BG Rhee, Korean firm SCM Lifescience has engaged in several global M&A deals in the past year with the end goal of…
Genome & Company, with a market cap of USD 280 million, is the highest valued microbiome company worldwide. Dr Jisoo Pae, its co-founder and CEO, sat down with PharmaBoardroom to…
After failing to attain reimbursement for its Amyotrophic Lateral Sclerosis (ALS) treatment NEURONATA-R® in Korea, Corestem has its sights set on the US market and an Investigational New Drug (IND)…
Kyung Suk Kim, CEO of Corestem, the first company to receive approval for a stem cell therapy for Amyotrophic Lateral Sclerosis (ALS) in Korea, recounts the firm’s main achievements since…
With over 30 years of experience in public office working in public health and pharmaceutical policy, food and drug safety regulations, national health and welfare policy, and overseas missions as…
Dr Bae Byuongjun, president of the Korea National Enterprise for Clinical Trials (KoNECT), outlines why Korea stands out in the APAC region as a top clinical trial destination, how clinical…
Founder, CEO and CTO Dr Chae-Ok Yun introduces GeneMedicine, a pioneer of the oncolytic virus approach in gene therapy. Dr Yun outlines the significance of a recent capital injection, ongoing…
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