Seasoned clinicians from leading academic medical centers from around the world serve as members of our data safety monitoring boards (DSMB) and clinical event committees (CEC). Many of our world class experts have worked with the FDA to craft the definitions used to adjudicate events in clinical trials. BCRI provides event adjudication services using either a paper or an electronic format. Our CEC members review events on an ongoing / daily basis and have always met a sponsor’s timeline.
We offer the following services:
Clinical Event Committee (CEC) Services
- CEC member selection & training
- CEC charter preparation
- CEC management (collection of events, coordination of meetings)
- CEC adjudication case report form design and review
Data Safety Monitoring Board (DSMB or IDMC) Services
- DSMB member selection
- DSMB charter preparation
- DSMB meeting coordination
- Independent statistical support for DSMBs