Independent monitoring of your clinical trial to ensure patients’ safety is critical. The Safety Board or DMC (Data Monitoring Committee) reviews safety and key efficacy data to ensure patients’ safety during their participation in your clinical trial and is charged with making recommendations based on interim analyses and in line with stopping rules to ensure patient’s safety with adherence to GCP (Good Clinical Practice).
ITREAS has extensive experience in setting up and managing Safety Boards and has an excellent network of physicians and scientists to function on such boards or committees. We can manage the entire Safety Board process, from charter development and management of the committee, up to the provision of the safety and other trial related data to the Safety Board.
Members of the Safety Board are selected by the Steering Committee and ITREAS in consultation with the sponsor. Members will be selected based upon relevant expertise, experience in clinical trial conduct, experience in serving on other Safety Boards and the absence of significant conflicts of interest.
Our Safety Boards operate independently from the sponsor and other parties involved in the clinical trial and report directly to the Steering Committee. In addition to its primary role in ensuring patient’s safety, the Safety Board can be tasked with other study critical responsibilities not directly related to subject safety but for which it is uniquely positioned to manage due to its independency.