MCRA's DSMB and CEC services help ensure adequate safety oversight during clinical trials and increase the reliability and poolability of your trial data.
Data Safety Monitoring Board (DSMB) Services
One of the most important aspects of certain clinical trials is the establishment of a Data Safety Monitoring Board. This is a group made up of independent experts who are responsible for evaluating the integrity of trial data and ensuring the safety of trial participants. The purpose of these panels is to create an independent party with no ties to either the manufacturer or the regulating body. MCRA brings experience and expertise that is critical for preparing and evaluating the complex and detailed information these bodies examine.
MCRA prepares for, participates in, and works with the data management team to identify events requiring adjudication for each Data Safety Monitoring Board meeting. Specifically, MCRA will provide the following DSMB services:
DSMB Setup Activities:
- Charter Development
- Adjudication Form Development
- Member Selection
- Contract Development & Negotiation
Per Meeting Activities:
- Clinical Document Retrieval
- Patient Dossier Development
- Identification of Adjudicable Events
- Planning & Coordination of DSMB Meetings
- Participation in DSMB Meetings
- Post-Meeting Review & Meeting Minutes
- Communicate DSMB Results to Sites
Clinical Events Committee (CEC) Services
Clinical Events Committees serve as a central decision-making group with the goal of standardizing outcomes and optimizing data quality. Its purpose is to review potential safety and efficacy endpoints to determine whether they meet protocol definitions and criteria. MCRA’s experience ensures organizations have the resources they need to handle the varied and complicated information this work entails.
MCRA prepares for, participates in, and works with the data management team to identify events requiring adjudication for each Clinical Events Committee meeting. Specifically, MCRA will provide the following CEC services:
CEC Setup Activities:
- Charter Development
- Adjudication Form Development
- Member Selection
- Contract Development & Negotiation
Per Meeting Activities:
- Clinical Document Retrieval
- Patient Dossier Development
- Identification of Adjudicable Events
- Planning & Coordination of CEC Meetings
- Participation in CEC Meetings
- Post-Meeting Review & Meeting Minutes
- Communicate CEC Results to Sites
MCRA Delivers Comprehensive Expertise
In addition to the experience MCRA brings to the table in terms of DSMB and CEC services, we also leverage a full range of CRO capabilities. Clients choose us because they know we provide proven expertise and can scale our offerings to provide as much or as little assistance as the situation warrants. To learn more about our complete capabilities and how they can ensure a smooth clinical trial experience, reach out and speak with one of our representatives today.
