It’s not easy to navigate through all clinical safety needs, but genae is happy to assist you through the different processes. Thanks to years of experience and close cooperation with key opinion leaders we will guide you to fast market approval.
Every clinical trial should have an efficient safety program and appropriate level of protection for the study subjects. genae has a transparent and reliable approach to safety data and a sturdy quality system. We can offer you a comprehensive Safety Management Plan, tailored to your device and the development stage.
Data Safety Monitoring Boards (DSMB) and Clinical Event Committees (CEC) are crucial to provide independent oversight of study data and methodology, and to review adverse events and protocol deviations. genae has a close collaboration with key opinion leaders across the world and hence can recruit expert physicians to form highly qualified DSMB and CEC. We manage their activities and ensure endpoints are adjudicated. The latter can be done remotely via a proprietary online platform or during physical CEC meetings.
By convention, one of the key ways that risks of therapy are conveyed is by using tables that capture frequencies of adverse events (AEs). These AE tables are part of virtually all major clinical trials, and such data are frequently presented in package inserts that accompany regulatory approval.
genae provides full adverse event management and reporting services:
Our multilingual team will make sure any adverse events are documented and managed properly.
Want to hear more about our services or how we can support your project? Feel free to contact us with any questions you may have.Contact us