Independent Data Monitoring
Independent Data Monitoring Committee (DMC) services are an essential component of many clinical research programs today. BBCR, in collaboration with
PROMETRIKA, offers independent DMC services providing the full range of professional expertise with the highest levels of independence and flexibility which produce the unbiased expert reporting for your clinical research programs.
The therapeutic area and drug safety and risk management physicians work closely with the sponsor's team. We are uniquely qualified to address DMC 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 DMC 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 samless turnkey solution with all of the necessary support to successfully manage the operations of your product's DMC. Click here to download our latest presentations on Data Safety Monitoring Boards.
Click
here to download the presentation