Data Monitoring Committees
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:
- Serving as a statistical expert on the DMC
- Preparing the data management and statistical sections of the DMC Charter
- Drafting the analysis plan with mock tables and listings
- Coordinating DMC meeting arrangements
- Programming and validating the DMC deliverables
- Freezing the data and handling unblinding issues
- Reviewing and QC’ing results prior to distribution
- Writing and securely distributing the report to DMC members prior to the meeting
- Presenting results at the DMC meeting
- Recording open and closed session DMC meeting minutes
- Responding to data and analysis issues on demand
- Providing safety updates to the DMC
- Facilitating communications between the Sponsor and the DMC
- Maintaining and archiving DMC documentation
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