National Taiwan University Hospital

Clinical Trial Center (CTC-NTUH)

Introduction

Biotechnology and pharmaceutical industry are Taiwan’s two most important developing businesses in the 21^st century. In the past few years, effort in promoting globalization of clinical trial business in Taiwan has just started. This includes studies in the area of biotechnology and pharmaceutical products, and the recent developed new concept of Bridging Studies. This joint force is collaborated by government, pharmaceutical industry, contracted research organization and medical centers. As a result of the promotion in conducting the gold standard ICH-GCP compliance clinical trial business, the volume of clinical trials has increased both in Taiwan and in National Taiwan University Hospital (NTUH).

Clinical Trial Center, NTUH

Clinical Trial Center of National Taiwan University Hospital (CTC-NTUH) is designed to fit the needs of globalization clinical trial business. CTC-NTUH is established by the funds of two resources from both the Department of Health and NTUH in December 2000. The primary role of CTC-NTUH is to provide a fully GCP compliance facility for clinical trials such as in BA/BE, PK/PD, and phase I, II, III, IV. Development of clinical trial methodology for herbal extract is also one of the missions of this center. In addition to help the sponsor and investigators conducting an ICH-GCP/GLP standard clinical trials, the ultimate goal of CTC-NTUH is to integrate resources in NTUH and to work with other units in Taiwan to attract international clinical trial business into Taiwan and to work with domestic pharmaceutical companies for new drug development.

NTUH Medical Center

The mission of the National Taiwan University Medical Center, which encompasses the College of Medicine (NTUCM) and the teaching hospital (NTUH), is to educate and train students, physician, and biomedical scholars and to provide a spectrum of comprehensive knowledge, research, patient care and service of the highest quality to the population of Taiwan and beyond. The Medical Center has a strong faculty working at the cutting edge of biomedical research, such as research on cancer, hepatitis, diabetes, immunology, lymphoma, and surgery, as well as diseases of the cardiovascular, pulmonary, gastronintestinal, and hematological system State-of-the-art technology is now being developed in our programs in cellular and molecular medicine, molecular diagnosis, microsurgery, virology, human genetics, and other important scientific fields..

Facility

■12 Inpatient Beds

■2 Examination Rooms

■Pharmacy

■Archive Room with Fire Safe

■Laboratory for Sample Processing

■Computer Room

■Recreation Room

■Office

Services Provided

■All Phases of Clinical Studies

■Bioavailability/Bioequivalent Studies

■Pharmacokinetic/Pharmacodynamic Studies

■Nutritional Foods Studies

■Medical Devices and Instruments Studies

■Herbal and Botanical Products Studies

Full Scale of Services

■Protocol Design

■Non-Patient/Patient Care

■Study Monitoring

■Data Management

■Statistical Analysis

■Report Writing

■Education and Training

Team of Excellence

■Director ■Deputy Director ■Project Manager

■Biostatistician ■Pharmacists ■Data Manger/Programmer

■Research Nurse ■Laboratory Technician

Contact: CTC, National Taiwan University Hospital

No. 7 Chung Shan South Road, Taipei, Taiwan

Tel:+886-2-2312-3456 ext.6590

Fax:+886-2-2371-0262

E-mail:ctc@ha.mc.ntu.edu.tw