GCP Introduction
GCP Development History
To meet the needs of high-quality development in hospitals, enhance competitiveness within the industry, improve clinical research capabilities and management levels of drugs and medical devices, and promote the internationalization process of hospitals, Shanghai International Medical Center officially began preparations for a "Clinical Trial Institution" on May 23, 2017.
In September 2018, the registration for the medical device clinical trial institution was completed.
In October 2019, certification for drug clinical trial qualifications was obtained.
By 2020, registration for the drug clinical trial institution was completed.
GCP Specialties and Research
Shanghai International Medical Center's clinical trial institution has a GCP office, GCP pharmacy, and GCP archives, as well as multiple clinical specialties such as oncology, urology, general surgery, etc. Currently, they have conducted two drug clinical trials, one medical device clinical trial, and several investigator-initiated clinical studies.
GCP Office
GCP Pharmacy
GCP Archive Room
Clinical Trial Management
Our organization has established a comprehensive clinical trial management system, standard operating procedures (SOPs), and a sound quality assurance system. We adhere to the quality management model of "putting subjects at the center and integrating the management of researchers, CRAs, and CRCs." We promptly identify, report, and address any issues that arise before, during, or after clinical trials. All members of our organization's management team and researchers will uphold a rigorous scientific attitude and a high level of responsibility in their research spirit to ensure the quality of clinical trials and provide high-quality services for applicants.
