Everest’s statistical and data management teams have strong experience in supporting Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB) activities.
Everest’s DMC/DSMB Administrators efficiently coordinate between committee members, statistical/data management teams, and the trial sponsors. All of our DMC/DSMB activities have been conducted smoothly and successfully.
- Administration of Clinical Study DMC/DSMBs.
- Write charters for clinical study DMC/DSMB.
- Identify and engage board members.
- Design and develop study data review summary tables, subject data listings, and graphs (TLGs).
- Generate and validate study data review TLGs and provide them to the DMC/DSMB prior to the data review meetings.
- Schedule and facilitate DMC/DSMB meetings, take meeting minutes (DMC/DSMB Secretary).
- Interact and communicate with trial sponsor and regulatory agencies on behalf of the sponsor in accordance with the DMC/DSMB Charter.