Data Monitoring Committee (DMC) services are required to monitor safety and/or efficacy for many clinical trials. EMB provides essential data management and statistical support to ensure timely and accurate results to the committee. Our seasoned statisticians have supported DMCs as both a committee member and the unblinded support statistician. Hence our team can provide expertise to interpret results, address data issues, or handle ad-hoc requests on-demand.
EMB also has experienced data management, programming, and project management personnel to provide data and program quality reports as well as manage the DMC activities.
Frequently requested services include the following:
In all matters, EMB follows the FDA and EMA Guidance for Clinical Trial Sponsors regarding DMCs and ICH Good Clinical Practice Guidelines. In addition, EMB can simultaneously support both blinded and unblinded teams within our organization.
EMB Statistical Solutions, LLC | 55 Corporate Woods, 9300 West 110th Street, Suite 550, Overland Park, Kansas 66210 | 913.322.6555