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
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
MCRA prepares for, participates in, and works with the data management team to identify events requiring adjudication for each Clinical Events Committee (CEC) 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
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