Oncology studies, in particular, present a number of additional challenges beyond the traditional issues of regular clinical trials. To successfully address these challenges, working with professionals that have a strong background and extensive expertise in oncology in general, and the type of cancer investigated in your study in particular, is essential. The earlier you engage these experts the more likely your trial will be designed and conducted in a manner that meets your protocol specifications and overall expectations.
The Banook Group Chief Medical Officers are active participants in Drug Advisory Committees and the Cardiac Safety Research Consortium (CSRC). They have broad experience in interacting with regulatory authorities, conducting face to face meetings with them in the US, Europe and other regions of the world (FDA, EMEA, ANSM, PMDA, Health Canada), and taking part in Data Safety Monitoring Boards in a chairman or expert role.
Moreover, the Banook Group has also extensive experience interacting and consulting with sponsors on the design and conduct of clinical programs and related activities, such as protocol writing, study design, analysis and reporting. These years of experience ensure we have a thorough understanding of your needs and operating procedures and can work with you effectively in the management of clinical data acquisition and analysis in your project.