An innovative medical device company appointed GCT to perform clinical trials for the state registration of a non-invasive device for coronary stents. GCT is proud to be a part of the team which will bring this cutting-edge technology on the market. For the successful conduct of clinical trial in the future we are initially providing Sponsor with the vital segment of clinical research — medical writing services.
Medical writing includes creation of scientific documents of different types which include regulatory and research-related documents, such as Clinical Trial Synopsis and Protocol, Patient Information Leaflets, Clinical Investigator’s Brochures, Informed Consent Documents, Study reports, Subject Narratives, Risk management plan for pharmacovigilance.
Cardiovascular diseases (CVD) are the leading cause of death globally. According to WHO, coronary artery disease and stroke account for 80% of CVD deaths in males and 75% of CVD deaths in females. Most cardiovascular disease affects older adults. As a rule, CVD is caused by a combination of such factors as smoking, obesity, sedentary lifestyle and alcohol abuse, elevated blood pressure and diabetes. Surgery is considered to be one of the most effective CVD treatments. Mostly it involves coronary artery stenting. The revolutionary approach to safe coronary stent positioning is aimed not only at improvement the quality of patients’ life, but also makes the whole procedure simpler, faster and more cost-effective. With the use of the novel medical device the movements of surgeons can be more precise which leads to safety and effectiveness of the most complex and demanding moment of a surgery – stent positioning.