Data Monitoring Committee (DMC) / Clinical Endpoint Committee (CEC) 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) and Clinical Endpoint Committees (CECs).   

Averion recognizes that an effective DMC ensures the safety of each study subject and relies upon quality data, timely communication, and clinical trial integrity. We understand that DMC recommendations for study continuation, modification or termination can have a significant impact on a product's development.   Similarly, a properly run CEC will ensure a standardized, systematic, independent, and unbiased assessment of clinical trial endpoints across all subjects and sites.  

To help facilitate DMC/CEC 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/CEC Charters, coordinate DMC/CEC meetings and logistics, facilitate communication with the members and helps ensure the independence of the DMC/CEC.

It is important to remember that not all studies require a DMC or CEC.   DMCs are particularly recommended for randomized,  multi-center studies that evaluate treatments with mortality endpoints or that are intended to reduce the risk of a major adverse health outcome. Studies of novel therapies or high-risk indications may also be appropriate for DMC involvement.  CECs are advisable when endpoints or key safety events in a clinical trial include mortality or morbidity, or can be subjective to reviewer bias (such as radiological tumor assessment) and/or cultural differences in multinational trials.

• Identification and Recruitment of Experienced Members
• Charter Development
• Data Analysis and Preparation of DMC Reports
• Collation of CEC Adjudication Events
• 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