At the forefront of cardiovascular health, we have gathered an interdisciplinary elite team in the field of cardiovascular disease to explore new knowledge about cardiovascular diseases, laying a solid scientific foundation for drug development, treatment strategy optimization, and disease prevention.
Crafted with ingenuity to create a full chain solution for the cardiovascular field
Our meticulously crafted cardiovascular research solutions are not only flexible and versatile, but also have a forward-looking perspective, which can accurately meet the full chain needs from basic exploration to clinical application. Through unremitting efforts in recent years, GCP ClinPlus has successfully participated in and led multiple milestone cardiovascular research projects, accounting for 14% of the total number of Prusheng projects.
Obtaining the National Registration Certificate Project:
● The imported product ticagrelor, undertaken by GCP ClinPlus, underwent a large-scale Phase IV trial after its launch, mainly evaluating its safety and incidence of major cardiovascular events in patients with acute coronary syndrome. The trial was successfully completed in 2016 in compliance with drug registration approval and regulatory requirements. During the more than 3-year clinical trial process, the GCP ClinPlus project team actively promoted and closely cooperated with the sponsor and supplier teams to overcome various risks and challenges caused by long trial cycles, a large number of centers with a wide distribution (104 centers), a large sample size (over 2000 cases), and strict CFDA verification requirements. The trial was successfully completed with quality and quantity guaranteed, and all documents were submitted according to the sponsor's SOP requirements for CFDA's post market safety reassessment.
● The innovative product "Abdominal Aortic Covered Stent System" undertaken by GCP ClinPlus was approved for market in October 2017. As a domestically produced abdominal aortic covered stent system designed with barbed bare stents, this product increases patients' clinical choices, effectively reduces clinical treatment costs, and alleviates patients' burden. Prusheng is honored to provide clinical operational services for this project.