Independent Data Monitor Committee (IDMC)

IDMC is an essential component of clinical research. BBCR offers IDMC services providing a full range of professional expertise with the highest levels of independence and flexibility for unbiased review and report.

BBCR’s team is uniquely qualified to address IDMC planning and execution including:

• Recruit and engage the highest caliber physicians from a global network of renowned key opinion leaders   in all relevant therapeutic areas
• Drug safety and risk management experts to lead and chair both IDMC open and closed sessions as well as coordinate data review
• Formulation of recommendations in accordance with established standard procedures in regulatory review
• Development of the charter and statistical analysis plan
• Statistical analysis of interim safety and efficacy data
•       Comprehensive safety and study monitoring
•       Preparation of reports
•       Organization and coordination of meetings

We provide a seamless turnkey solution with all of the necessary support to successfully manage the operations of your product’s IDMC.

Click here to download our latest presentations on Data Safety Monitoring Boards.