Data Safety Monitoring Boards
According to the FDA guidance, “An independent DMC is a committee whose members are considered to be independent of those sponsoring, organizing, and conducting the trial.”
Watermark is your solution to an independent safety review. A Data and Safety Monitoring Board (DSMB) is often a requirement for clinical trials. A DSMB is an independent group of experts that conduct a periodic review of accumulated data during a clinical trial. The purpose of the DSMB is to report early evidence of benefit or harm, taking into account the safety of the patients, and the integrity and validity of the data. The key to an effective DSMB is truly independent members. DSMB members should not have any conflicts of interest that may compromise an unbiased review and recommendation.
Watermark provides the essentials to conduct a successful data and safety monitoring board for your study:
- Large database of potential independent board members
- Sponsor independence and corporate transparency
- Audit support and standardized reporting
- Watermark supports all independent panels including IDMC, CEC, endpoint committees, ascertainment committees, and adjudication panels