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中山醫學大學附設醫院-西藥、醫材暨新醫療技術臨床試驗中心Chung Shan Medical University Hospital-New Drug, New Medical Device, New Medical Technology Clinical Trial Management Center

  • Total Beds1,134
  • Total Doctors483
  • AddressNo.110,Sec.1,Jianguo N.Rd.,South,Taichung City 402
  • ContactMiss Liu
  • Emailcshgcrc@csh.org.tw

1. Provide one stop shop service window

2. Online contract reviewing system.

3. Regularly hold clinical trial education training courses

Site Introduction

In order to improve the research quality, Chung Shan Medical University Hospital (CSMUH) has established the New Drug, New Medical Device, New Medical Technology Clinical Trial Management Center in 1995, which was also named General Clinical Research Center (GCRC). We have a variety of well-experienced research teams with first-rate investigators in all fields of medical service and health provision. We all adhered strictly to the ICH-GCP and regulatory guidelines of Taiwan. We have excellent record that some principal investigators have succeeded in the official inspections by the TFDA Taiwan, the PMDA Japan and the FDA USA. We have been awarded the lead center to conduct the project of 「Establishment of the Key Environment for the Development of Good Clinical Trial」with excellent performance. We offered many clinical training courses in research ethics, sciences, regulations and GCP. We also invited a variety of experts, including disinterested community members, volunteer associations, industry, academic representatives and governmental authorities. We not only proposed every one with the proposed excellent training curriculum for everyone, but also presented each person with the comprehensive, novel, and practical clinical trial and human research related information.In order to encourage the cooperation between the outstanding investigators of our institution and the representatives of pharmaceutical industries, we invited them to discuss regularly. On the basis of TFDA regulations, we have played the good role of Site Management Organization (SMO), as well as have signed the contracts with several big pharmaceutical companies to establish and promote the excellent key environment in carrying out high quality clinical trials.

Clinicl Trial Expertise

Drugs, foods, cosmetics, edicinal products, post-marketing monitoring

International Accreditation

GCP Inspection/audit

PMDA

 

US FDA

What types of clinical trial do you conduct?

Spotlights

CTC

The Food and Drug Administration of the Ministry of Health and Welfare awarded the award for the "103 Multi-Center Integration and Quality and International Competitiveness Enhancement Project for the Implementation of New Drug Clinical Trials in Medical Institutions".

The Department of Health of the Executive Yuan commended the Center for its efforts to implement the "Improving the Key Environment for Comprehensive Drug Testing in Clinical Trials". It will contribute to improving the research and development efficiency of new drugs in the domestic biotechnology industry and safeguarding people's lives.

The clinical trial plan of "Vortioxetine for daily medical practice for patients with severe depression in Asia-Taiwan study (TREVIDA) (plan number: 18150N; our hospital case number: CS2-19025)" Since August 2008, he has taken over as the chief moderator of the Taiwan Regional Test Plan.

The hospital's Department of Oncology, Dr. Wu Mingfang, performed “A randomized, double-blind, double-dummy, parallel group, international multicenter study assessing the efficacy and safety of a netupitant-palonosetron Fixed Dose Combination (FDC) compared to an extemporary combination of granisetron and aprepitant on the prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with cancer” (program ID: NETU-12-07; our hospital case number: CS13172), since July, 104 Taking over as the chief moderator of the Taiwan Regional Test Plan, the value is affirmative.

 

The hospital's Department of Oncology, Dr. Wu Mingfang, performed “A randomized, double-blind, double-dummy, parallel group, international multicenter study assessing the efficacy and safety of a netupitant-palonosetron Fixed Dose Combination (FDC) compared to an extemporary combination of granisetron and aprepitant on the prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with cancer” (program ID: NETU-12-07; our hospital case number: CS13172), since July, 104 Taking over as the chief moderator of the Taiwan Regional Test Plan, the value is affirmative.

Publications

CTC

1

Chang, C. C., Lee, C. T., Lan, T. H., Ju, P. C., Hsieh, Y. H., & Lai, T. J. (2015). Effects of antidepressant treatment on total antioxidant capacity and free radical levels in patients with major depressive disorder. Psychiatry Res, 230(2), 575-580. doi:10.1016/j.psychres.2015.10.006

2

Ju, P. C., Chou, F. H., Lai, T. J., Chuang, P. Y., Lin, Y. J., Yang, C. W., & Tang, C. H. (2014). Long-acting injectables and risk for rehospitalization among patients with schizophrenia in the home care program in Taiwan. J Clin Psychopharmacol, 34(1), 23-29. doi:10.1097/JCP.0b013e3182a6a142

3

Double-Balloon Enteroscopy for Bleeding Meckel's Diverticulum in a Child Aged Less Than Four Years Gastrointestinal Endoscopy Volume 70, No. 2:2009Shan-Ming Chen, MD, Ching-Pin Lin, MD,Taichung,Taiwan

4

6-Gingerol Inhibits Growth of Colon Cancer Cell LoVo via Induction of G2/M Arrest Evidence-Based Complementary and Alternative Medicine Volume 2012 Ching-Pin Lin, Chun-Che Lin, and Gregory J. Tsay

5

Clinical Characteristics and Outcome in Norovirus Gastroenteritis The Indian Journal of Pediatrics(2014) Ching-Pin Lin, Shan-Ming Chen

6

Faecal calprotectin as a novel biomarker for differentiating between inflammatory bowel disease and irritable bowel syndrome MOLECULAR MEDICINE REPORTS(2014) Jen-Wei Chou, Shan-Ming Chen, and Ching-Pin Lin

7

Anti-oxidant and anti-inflammatory effects of hydrogenrich water alleviate ethanol-induced fatty liver in mice World Gastroenterol 2017 Ching-Pin Lin, Wen-Chen Chuang, Fung-Jou Lu, Chih-Yen Chen

8

Ho LT, Yin WH, Chuang SY, Tseng WK, Wu YW, Hsieh IC, Lin TH, Li YH, Huang LC, Wang KY, Ueng KC, Fang CC, Pan WH, Yeh HI, Wu CC, Chen JW; Taiwanese Secondary Prevention for patients with AtheRosCLErotic disease (T-SPARCLE) Registry Investigators. Determinants for achieving the LDL-C target of lipid control for secondary prevention of cardiovascular events in Taiwan. PLoS One. 2015 Mar 10;10(3):e0116513.

9

Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Køber LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. (Ueng KC et al.). Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.

10

Chou CH, Ueng KC, Liu YF, Wu CH, Yang SF, Wang PH. Impact of Intercellular Adhesion Molecule-1 Genetic Polymorphisms on Coronary Artery Disease Susceptibility in Taiwanese Subjects. Int J Med Sci. 2015 Jun 9;12(6):510-516.