Introduction to Clinical Trial Institutions

Introduction to Clinical Trial Institutions

Zhejiang Hospital is a drug clinical trial institution and a medical apparatus clinical trial institution in record. The hospital is divided into Lingyin Campus and Sandun Campus, in both of which drug clinical trials and medical apparatus clinical trials can be conducted.

The institution was first accredited as a drug clinical trial institution by China Food and Drug Administration in October 2005, and all specialties passed the qualification recognition review of “National Drug Clinical Trial Institution” in 2017. After years of development, the institution has built complete organizational structure and management system and has accumulated a wealth of experience in clinical trials. It also keeps abreast of the changes in laws and regulations. And depending on the development of the hospital, many outstanding researchers has emerged in the institution through continuous learning. In March 2020, the institution completed the registration of 39 drug clinical trial specialties for record in accordance with the requirements of the relevant regulations of the National Medical Products Administration. Aforesaid specialties include: cardiovascular medicine, respiratory medicine, geriatrics, gastroenterology, neurology, endocrinology, immunology, hematology, nephrology, general medicine, intensive care medicine, oncology, general surgery, thoracic surgery, urology, cardiac macrovascular surgery, vascular surgery, neurosurgery, orthopedics, breast surgery, plastic surgery, medical cosmetology, anorectal surgery, rehabilitation medicine, anesthesiology, psychiatry, ophthalmology, obstetrics and gynecology, emergency medicine, stomatology, pediatrics, lemology, pain management, traditional Chinese medicine (internal medicine, acupuncture, massage), medical imageology (radiology, ultrasound diagnosis) and Phase I clinical trial lab. To date, the institution has conducted more than 200 drug clinical trials, covering Phase I, II and III clinical trials of new drugs, clinical validation of imported drugs and post-marketing drug re-evaluation. The Phase I clinical trial lab now has 60 beds, which can fully meet the requirements for clinical trials of new drugs and generic drugs.

The institution first completed the registration of Medical Apparatus Clinical Trial Institution in record in December 2018, and there are currently 41 medical apparatus clinical trial specialties, including cardiovascular medicine, respiratory medicine, gastroenterology, neurology, hematology, nephrology, endocrinology, immunology, geriatrics, general medicine, oncology, intensive care medicine, gynecology, obstetrics, pediatrics, ophthalmology, stomatology, medical cosmetology, mental health, lemology, rehabilitation medicine, anesthesiology, medical laboratory science, pathology, medical imageology (ultrasound diagnosis, radiology, electrocardiography), traditional Chinese medicine (internal medicine, acupuncture, massage), general surgery, orthopedics, neurosurgery, neuroInterventional Surgery, urology, thoracic surgery, plastic surgery, breast surgery, cardiac surgery, vascular surgery and anorectal surgery. Clinical trials of Class II and Class III medical apparatus and diagnostic reagents in vitro can be conducted here.

The institution has a rapid development and gains a good reputation at home. It has undertaken and completed one of the National Major Scientific and Technological Special Projects during the Twelfth Five-year Plan Period -"Technology Platform for Clinical Evaluation and Research of New Geriatric Drugs", and has held for years the National Continuing Medical Education Program "GCP and Ethics Training Course for Geriatric Drug Clinical Trials" and provincial Continuing Medical Education Program " Course on Quality Management and Ethical Review of Medical Apparatus Clinical Trials".

Lingyin Campus:

Tel: 0571-87986519,0571-81595227

E-mail: zjyyjgb@163.com

Contact: Lee or Lin

Office Address: Room 121, Outpatient Building, Zhejiang Hospital, No.12, Lingyin Road, Hangzhou, Zhejiang Province, China

Working Hours: Monday to Friday 8:00 a.m. - 12:00 a.m. and 1:30 p.m. - 5:00 p.m.

Postal Code: 310013

Sandun Campus

Tel: 0571-87377026

E-Mail: zjyyjgb@163.com

Contact: Lee

Office Address: Room 306, Science Education Building, Zhejiang Hospital, No.1229, Gudun Road, Hangzhou, Zhejiang Province, China

Working Hours: Tuesday and Friday 8:00 a.m. - 12:00 a.m. and 1:30 p.m. - 4:00 p.m.

Postal Code: 310030