The ward and laboratory of the PUMCH Clinical Pharmacology Center Phase I have been relocated into the 6th and 7th floor of the Translational Medicine Complex on January 16, 2022, and completed the follow-ups on the first batch of test subjects after the relocation on January 20. This means that the Clinical Pharmacology Center Phase I has been officially inaugurated at the new site and is now open to the public.

The ward of the Clinical Pharmacology Center Phase I covers an area of 1,566 square meters, and its 48 beds are equipped with ECG monitors that provides real-time monitoring of the test subjects. The ward is divided into a research clinic, blood collection room, treatment room, rescue room, specimen processing room, reference room, CRC work area, research nurse work area, subjects-only rest area, and meal preparation room, and is capable to accommodate early-stage clinical research with both healthy test subjects and patients. The ward is dedicated to the early-stage clinical trials of advanced innovative drugs and has accumulated rich experience. Compliant with relevant laws and regulations, the ward has also strengthened its IT applications, including establishing a clinical research volunteer database, a whole-process electronic management system, and independent bar code information collection system. With complete, accurate and high-quality data collection, and optimized management system, the ward will support the application and registration of new drugs and investigator-initiated clinical trials. In addition, the ward will also working on facilitating the integrated Phase I research ward as well as the process from early stage to Phase II/ III clinical trials that cover both healthy people and patients.

Covering an area of 500 square meters, the laboratory of the Clinical Pharmacology Center Phase I is a research-oriented bioanalytical laboratory with a core competitive edge of advanced clinical pharmacology technologies. The experimental platform is equipped with 94 pieces (sets) of equipment, and has established an analytical platform for the quantitative and qualitative biological analysis of chemical and biological drugs up to international standards. The laboratory is now focusing on the quantitative and qualitative analysis of biological drugs at the new site to improve the clinical research capabilities in new antibody drugs and vaccines, including new biological drugs for immune cell, gene and stem cell therapies.

The professional group of the Clinical Pharmacology Center Phase I has seen great improvement in software and hardware conditions for clinical research after relocation. The center will forge an innovative chain that covers basic research, clinical application, translational medicine, and industrial transformation. The Phase I professional group will also apply AI and big data technology to empower clinical research and further enhance the in-depth mining and analysis of clinical trial data. It will also improve the efficiency of clinical research and development of innovative drugs through establishing pharmacological and pharmacodynamic models, and applying such strategies as optimizing target group screening and dosage selection based on early-stage clinical data, and create a “PUMCH model” of drug clinical research with a new generation of information technology.

The internal environment of the Clinical Pharmacology Center Phase I at the Translational Medicine Complex

Written by: The Clinical Pharmacology Center

Photo: Sun Liang

Translator: Liu Haiyan

Editor: Zhang Yang and Wang Yao