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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 Qiu
  • Emailcshgcrc@csh.org.tw
Link to Hospital Link to Clinical Trial Center

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

Feng-Ching Yanng, Kwo-Chang Ueng. Persisting Rest Pain and Claudication of a Critical Limb Ischemia Patient After Performing a Superficial Femoral Artery Antegrade Approach Procedure. Journal of the American College of Cardiology. 2017;69(16):S312.

2

Lin YN, Chang SS, Wang LM, Chi HT, Ueng KC, Tsai CF, Phan CS, Lu LH, Hii CH, Chung YT, Chugh SS, Chen MF, Wu TJ, Chang KC. Prehospital Predictors of Initial Shockable Rhythm in Out-of-Hospital Cardiac Arrest: Findings From the Taichung Sudden Unexpected Death Registry (THUNDER). Mayo Clin Proc. 2017 Mar;92(3):347-359. doi: 10.1016/j.mayocp.2016.10.029.

3

Lin HC, Lai TJ, Tseng HC, Wang CH, Tseng YL, Chen CY,(2019), Radiation doses with various body weights of phantoms in brain 128-slice MDCT examination. J. Radiat Res. 2019 Jul 01;60(4), 466-475.

4

Lin CY, Lai TJ, Wu YH, Chen PK, Lin YF, Chien IC. Corrigendum to "Change in 1-year hospitalization of overall and older patients with major depressive disorder after second-generation antipsychotics augmentation treatment" J Affect Disord. 2018 Jul; 234:162-163

5

Ho YJ, Weng JC, Lin CL, Shen MS, Li HH, Liao WC, Tsai NM, Chiu PY, Hung CS, Lai TJ*. Ceftriaxone Treatment for Neuronal Deficits: A Histological and MEMRI Study in a Rat Model of Dementia with Lewy Bodies. Behavioural and Cognitive Changes in Lewy Body Dementias. Hindawi Behav. Neuro 4618716, 9 pages, 2018.

6

Chang CC, Li HH, Chang YT, Ho YJ, Hsieh JL, Chiu PY, Cheng YS, Lin CL, Lai TJ*. Aβ exacerbates α-synuclein-induced neurotoxicity through impaired insulin signaling in α-synuclein-overexpressed human SK-N-MC neuronal cells. CNS Neurosci. Ther.24:47-57, 2018.

7

Chiu PY, Wang CW, Tsai CT, Li HH, Lin CL, Lai TJ*. Depression in dementia with Lewy bodies: A comparison with Alzheimer's disease. PLoS One. 12:e0179399, 2017.

8

Chao PY, Chiang TI, Chang IC, Tsai FL, Lee HH, Hsieh K, Chiu YW, Lai TJ, Liu JY, Hsu LS, Shih YC. Amelioration of estrogen-deficiency-induced obesity by Ocimum gratissimum. Int J Med Sci. 2017 Jul 20;14(9):896-901.

9

Chiang TI, Chang IC, Lee HH, Hsieh KH, Chiu YW, Lai TJ, Liu JY, Hsu LS, Kao SH. Amelioration of estrogen deficiency-induced obesity by collagen hydrolysate. Int J Med Sci. 2016 Oct 19;13(11):853-857. (SCI)

10

Chao PY, Lin JA, Ting WJ, Lee HH, Hsieh K, Chiu YW, Lai TJ, Hwang JM, Liu JR, Huang CY. Ocimum gratissmum aqueous extract reduces plasma lipid in hypercholesterol-fed hamsters. Int J Med Sci. 2016 Oct 18;13(11):819-824.

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