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English to Korean: Clinical Trial Protocol General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Monitors, auditors, and other authorized agents of XXXXXX and/or its designee, the IEC(s)/IRB(s) approving this research, and the Food and Drug Administration, as well as that of any other applicable agency(ies), will be granted direct access to the study subjects’ original medical records for verification of clinical study procedures and/or data, without violating the confidentiality of the subjects to the extent permitted by the law and regulations. In any presentations of the results of this study or in publications, the subjects’ identity will remain confidential.
Translation - Korean XXXXXX의 모니터 요원, 감사자 및 기타 권한을 위임 받은 요원 그리고/혹은 본 회사 피지명자, 본 연구를 승인한IEC(s)/IRB(s), 그리고 미국 식약청 및 기타 해당 기관은 법규가 허용하는 정도로 피험자 기밀을 준수하여 임상 시험 절차 그리고/혹은 데이터 획득이 진행되었는지 여부를 검증하기 위해 피험자의 원본 의무 기록에 직접 접근할 수 있다. 본 연구에 대한 모든 결과 제시 혹은 출판에서, 피험자 신원은 비밀로 유지된다.
Korean to English: Medical:Pharmaceuticals II
Source text - Korean 본 연구 계획서는 재조합 및 인간 혈장 유래 FVIII 제제의 임상 연구에 대한 EMA 지침 요구사항을 충실히 따른다 [5]. 본 연구는 중증 A형 혈우병 환자 (1% 미만의 내인성 FVIII 활성) 에서 시험약 PK 관찰을 위해 수행되었다. 치료 경험이 있는 피험자 모집단 (FVIII 농축제제로 150 EDs 를 갖은 사람들로 정의됨) 은 특별히 FVIII 억제인자 발생 위험이 낮은 사람들로 선별된다. 피험자는 억제인자에 대한 낮은 기대 발생율 (low expected incidence) 을 가지고 있다.
Translation - English This protocol follows closely the requirements of the EMA guidance on the clinical investigation of recombinant and human plasma-derived FVIII products [9]. The study is conducted in severe hemophilia A patients (
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Please visit: https:/hansangrow.com Welcome! I am a former PM currently working as a freelance translator in the field of medicine, pharmaceuticals and clinical trials. Years of hands-on experience in the pharmaceutical industry coupled with working with hospitals has given me the expertise to translate long and complex clinical documents with accuracy and precision. Also, I understand the general preferences when it comes to technical terminology as a result of working closely with some of the largest CROs in the industry such as Quintiles, Parexel, INC-Inventive Health, etc. In addition, my educational background in psychology/neuroscience allows me to translate academic papers to be published in peer-reviewed journals with the expected fluency and format required for concise scientific writing. Feel free to contact me anytime and you will not regret it! Cordially, Hansang ----------------------------------------------------------------------------------------------------------- Education: 2010/09-2016/03 Ph.D., in Neuroscience School of Biological Sciences Seoul National University, Republic of Korea (PI: Dr. Kyungjin Kim) 2004/09-2010/03 B.S., in Neuroscience and Psychology School of Literature and Sciences University of Michigan-Ann Arbor, Ann Arbor, Michigan, USA 2000/09-2004/05 Honor graduate Edgewood High School Madison, Wisconsin, USA ----------------------------------------------------------------------------------------------------------- Career: 2016/09-current PanGen Biotech Inc. RA Unit/ Manager Global clinical trial project organization, Clinical trial protocol writing, Project management and development, RA administrations, IND applications in MFDS, NPRA, FDA 2016/03-2016/09 Curecell® Scientific Advisor; Deputy manager Regulatory document writing, Develop SOPs, Market analysis for Gene Therapy and Regenerative medicine ----------------------------------------------------------------------------------------------------------- Journal Publications 1. Row, H., Jeong, J., Cho, S., Kim, S., and Kim, K. (2016). HL271, a novel chemical compound derived from metformin, differs from metformin in its effects on the circadian clock and metabolism. BBRC. 469(2016)783-789. 2. Park, N., Kim, H.D., Cheon, S., Row, H., Lee, J., Han, D.H., Cho, S., Kim, K. (2015). A Novel Bmal1 Mutant Mouse Reveals Essential Roles of the C-terminal Domain on Circadian Rhythms. PLoS One. 10(9):e0138661. ----------------------------------------------------------------------------------------------------------- Patents: 1. Pharmaceutical composition comprising N1-cyclic amine-N5-substituted biguanide derivatices as an ingredient for preventing or treating jet-lag syndrome. (KR. Submission # 10-2013-0009523) (Int. Cl. A61K 31/155). 2. Knock-out mouse for C-terminal region of Bmal1 and an use thereof. (KR. Submission # 10-2013-0121100). ----------------------------------------------------------------------------------------------------------- Major Projects/Previous Translation Queries 2012/11 Korea Environment Corporation/Korea University Environmental Section CCS Roadmap Development KORENG pptx 25 pages 2012/12 Hankook Research Health Care Related KORENG docs 4,719 words 2013/01 Hankook Research Clinical Query KORENG docs 1,274 words 2013/02 GfL HL Market Intelligence Supplementary Research (Questionair) ENGKOR docs 2,854 workds 2013/02 GfL HL Strategic Plan Questions KORENG docs 2,201 words 2013/02 GfL Hodgekin’s Lymphoma Intelligence Qualitative Review ENGKOR docs 9,866 words 2013/04 HL Research T2D_Related_Investigator_Interview KORENG [Total: 3 projects] pptx 20 pages, docs 40,575 words 2013/06 Asan Hospital Clinical Trial SAE KORENG docs 3,824 words 2013/10 NAM&NAM Patent ltd. Pat# XXXX1056731 Right Succession Agreement KORENG docs 6,054 words only scientific section 2014/01 Hankook Research Health Care Related (Breast Cancer Brochure) KOR-ENG pptx 17 pages 2015/09 CureCell Inc. GeneTherapy_Guideline_For_Researchers ENGKOR docs. 17,582 words 2015/10 PanGen BioTech Inc. Pharmaceutical GMP/.CMC /MV documents KORENG [Total: 23 projects] Technical Document Translation est. over 100,000 words 2016/05 INC/Inventive Health Clinical Trial Protocol Phase I/III ENGKOR docs 8,789 words ----------------------------------------------------------------------------------------------------------- **All the information above has been validated and copy of specific part can be requested. --------------------- Hansang Row Ph.D ---------------------
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