Introduction of Phase I Clinical Trial Ward ofChina-Japan Friendship Hospital

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Brief Introduction

Phase I Clinical Trial Ward (PICTW) is an important part of the Drug Clinical Trial Research Center (GCP Center), which located on the 7th floor of the west courtyard area of China-Japanese Friendship Hospital (warship hospital area), with an area of 900 m2 total surface area and 39 research beds.

PICTW has been set up and configured the comprehensive management system、 SOPs and quality system abides by current CNDA and ICH related regulations and technical guidelines for clinical trials. Core professional team have many years management and operation experience of phase I clinical trial center and projects, who can provide high-level clinical trial I services for domestic and foreign pharmaceutical companies.

Equipped with electronic data acquisition and transmitting digital electrocardiograph, ECG monitor, sphygmomanometer, urine drug screening instruments docking with the hospital HIS/LIS system, together with uninterrupted monitoring and automatic alarm system for drugs, sample storage and environmental temperature and humidity, can effectively ensure the accuracy, reliability, and traceability of clinical trial data.

Facility and Instruments

Facility functional partition:

Subject education area, IC room, screening room, clinical ward, treatment room, IMP room, archive room, nurse station, sample handling room, recreation area, diet room, monitor room, dirt chamber etc.
The ICU on the same floor is connected with the PICTW by a green channel, which ensures the rapid transportation and treatment of emergency cases.
The access control, video monitoring system, temperature and humidity monitoring system has been set up according to different functional area.

Instruments and Equipment：

Emergency room: emergency cart, ventilator, defibrillator, ECG monitor
Treatment room: infusion pump, injection pump, 12-lead ECG, sphygmomanometer, height and weight scale
IMP room: medicine IMP storage cabinets (room temperature, low temperature and constant temperature and humidity)
Sample Handling room: -40℃ low temperature freezers, -80 ℃ low temperature freezers, high speed refrigerated centrifuge

Our advantages:

Facility, equipment and instruments of PICTW have been set up and configured according to international and current CNDA’s standards:
Comprehensive SOPs and management system，QMS in line with principals of GCP
Core professional team have many years management and operation experience of phase I clinical trial center and projects, we has completed dozens of phase I clinical trials in past three years including, but not limited to, innovative drug tolerance studies and bioequivalence studies, and has been widely recognized in the industry.

The clinical studies can be carried out