Data Monitoring Committee (DMC) Services

Averion provides the necessary guidance for the establishment and management of Data Monitoring Committees (DMCs) (sometimes also referred to as Data Safety Monitoring Boards, DSMBs).   

Averion recognizes that an effective DMC ensures the safety of each study subject and the integrity of each clinical trial.  The DMC relies upon quality data, timely communication, and accurate reports. We understand that DMC recommendations for study continuation, modification or termination can have a significant impact on a product's development.  

To help facilitate DMC recruitment, Averion works with Sponsors to identify thought leaders in the relevant indications.  Averion maintains an extensive database of past and current members of such committees including their affiliation and specialties. 

Averion also helps Sponsors draft DMC Charters, coordinate DMC meetings and logistics, facilitate communication with the members and helps ensure the independence of the DMC.

Averion has a lengthy history of DMC management in many randomized, multi-center studies that evaluate treatments with mortality endpoints or that are intended to reduce the risk of a major adverse health outcome as well as studies of novel therapies or high-risk indications. 

• Identification and Recruitment of Experienced Members
• Charter Development
• Data Analysis and Preparation of DMC Reports
• Coordination and collaboration of data with central labs and  Adjudication Committees
• Meeting Coordination/Facilitation
• Safety Reports (adverse events, laboratory data, dropouts)
• Record Meeting Minutes
• Provide DMC Recommendations to Sponsors
• Present Final Endoint Adjudication forms to Sponsors
• Maintain DMC/CEC Files/Account Reconciliation Audit Central Files