Independent Data Monitoring
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.