GCP has professional cardiovascular clinical trial personnel who pay close attention to customer needs and have extensive clinical study execution and management experience.
Established good partnership with many experts in the area of cardiovascular and cerebrovascular to obtain their support.
Good partnership with hospitals and wide office locations facilitate to give quick support to the site to monitor clinical study data in a timely manner and to provide optimal management for large sample size and large-scale clinical trials.
Our clinical trial experience includes, but is not limited to, the following indications:
Hyperlipidemia, hypertension, coronary disease, acute coronary syndrome, stroke, PCI surgery, and atrioventricular septal defect repair, etc.
Successful projects obtaining the national registration certificate:
The Phase IV trial with large sample size of the imported product, Ticagrelor, which was undertaken by GCP, mainly assessing the safety and incidence of major cardiovascular events in patients with acute coronary syndrome, has been successfully completed in 2016 according to requirements of approval letter for drug registration and regulations. During the more than three years of clinical trials, the GCP project team actively propelled the project and worked closely with the sponsor and supplier teams, overcame a variety of risks and challenges brought about by factors such as long trial period, wide distribution of a large number of sites (104 in total), large sample size ( more than 2,000 cases) and rigorous CFDA inspection, successfully completed the test with quality and quantity guaranteed, and submitted all documents to CFDA for post-marketing safety re-evaluation according to the requirements of sponsor's SOP.
The innovative product “Abdominal Aortic Covered Stent System”, undertaken by GCP, was approved for marketing in October 2017. This product, the first marketed domestic Abdominal Aortic Covered Stent System with the design of barbed metal stent, increases the clinical treatment options for patients to choose, effectively reduces the cost of clinical treatment, and relieves the burden on patients. GCP is proud to provide services for clinical trial of the project.