Clinical Trials Management
We leverage our extensive expertise in medical, quality, research and research oversight to ensure clinical trials are successfully implemented. NYBC has performed many clinical studies related to blood, transfusion medicine, cellular therapy, and infectious disease. When conducting projects and studies, CCS utilizes its broad expertise and extensive infrastructure, which includes our blood operations, translational center, medical programs and services, and a growing network of collaborating blood and research centers across the country. These resources and background allow us to execute projects and studies with extensive attention to detail, exceptional quality and open interaction with the requester.
For organizations further along in planning and clinical development, CCS will review your protocols for scientific accuracy, feasibility, and design in order to maximize trial viability and validity.
For many years, our highly trained nurses and key personnel have been involved in subject recruitment. Our access to hundreds of thousands of normal, healthy donors can be utilized as the source of subject recruitment for studies. In addition, we also have individuals with positive test results for certain infectious diseases, or other specific qualities that can be used for study recruitment.
CCS PhDs and MDs are leaders in transfusion medicine, cellular therapy, immunology and epidemiology, and have designed, reviewed and overseen hundreds of research projects, preclinical and clinical studies. Utilizing this expertise, we will assist your research and development project or study, provide consultation on FDA requirements, certification and 510(K) application, as well as advise and direct regarding technical performance, improvements and adaptations to meet and exceed FDA certification requirements.