Introductionfor Phase I Clinical Trial Center


Established in 1835, SUN YAT-SEN MEMORIAL HOSPITAL, SYSU is the first hospital in China that provided western medical service and has been rated as a Class A tertiary general hospital by the Ministry of Health in China. With an exciting period of growth and expansion for over 100 years, the hospital has developed into a comprehensive hospital in China, famous for its medical service, education, research and health care. It shows great strength in clinically medical field and takes the lead in China. It has nine nation-level key clinical specialties and 23 province-level key clinical specialties.

Now it has a nation-level demonstration base of international cooperation for “long non-coding RNA and major diseases”, and has been included in the national difficult disease diagnosis and treatment capacity improvement project, the innovation system of national health medical big data classification with diagnosis and treatment, and has 18 provincial, ministerial and bureau level platforms, including the key laboratories of epigenetic inheritance and gene regulation of malignant tumor in Guangdong.

The hospital takes the lead in tumor microenvironment and RNA medicine research, and ranks among the top in clinical research on stem cells and immune cells in China. It has outstanding ability to undertake research tasks at all levels. The annual research funding is nearly 150 million yuan, and the number of annual projects of the National Natural Science Foundation remains among the top 20 in China.

Moreover, the hospital has increased its academic influence by publishing research articles at prestigious academic journals including Cell,Cancer Cell and J Clin Investigation. It published over 300 papers at SCI journals. The results have been awarded as one of the "Top Ten Scientific and Technological Breakthroughs in the World in 2003", the "Top Ten Scientific and Technological Progress of Chinese Higher Education Institutions in 2008", the First Prize of Guangdong Science and Technology Award, and the Second Prize of National Natural Science Award. It aims at clinical scientific issues, focuses on the mechanism of occurrence, development, prevention and treatment of diseases, and standardizes the development of the basic, applied, and translational medicine.

In 1986, our hospital was approved as one of the first “drug clinical trial institutions” by Ministry of Health. At present, 18 clinical professional groups have obtained the drug clinical trial qualification of the State Food and Drug Administration, and have completed nearly 200 clinical trials in the past five years, gaining lots of abilities and experience.

Phase I Clinical Trial Center of SUN YAT-SEN MEMORIAL HOSPITAL, SYSU

Phase I clinical trial is to explore the body's response and tolerance to drugs, and study the absorption, distribution, metabolism, and excretion of drugs in human body to observe possible adverse reactions, explore safe dose ranges, and obtain features of drug metabolism. It provides a scientific basis for further clinical trials and rational drug use.

Our orientation:

Establish a world-class research hospital.

Develop a clinical research team and improve clinical research discipline construction.

Comply with China's major innovations in clinical trials.

We establish Phase I Clinical Trial Center of Sun Yat-sen Memorial Hospital, SYSU, based on our rich clinical trial experience and resources in combination with SYSU’s mature technology and rich experience of phase I clinical trial.

Phase I Clinical Trial Center of Sun Yat-sen Memorial Hospital, SYSU (referred to as Phase I Center) has an excellent team, advanced technology, complete equipment and continuously improved management system.

Our goal: to establish a platform for international, first-rate and comprehensive phase I clinical trial

Our core: to provide standard and high-quality clinical trial services of innovative medicine in line with ICH-GCP and Chinese GCP standards

Our service:

Phase I drug clinical trial (body tolerance, pharmacokinetics)

Phase I clinical trial of anticancer drugs (body tolerance, pharmacokinetics)

Bioequivalence study

Pharmacokinetic/Pharmacodynamics study (PK/PD)

Population pharmacokinetics study

Genetic pharmacology study

Pharmaceutical genomics study

Drug metabolomics study

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