Data Safety Monitoring Board (DSMB) Management

Data Safety Monitoring Boards are an essential piece of many clinical trials by acting as an independent body providing high level safety oversight both at the individual patient and overall study levels.

Align CRO is experienced with assisting Sponsors in the creation and management of DSMBs to help monitor the safety of a clinical trial including the following:

• Coordinate the recruiting of qualified DSMB members

• Develop the governing DSMB charter for a clinical trial

• Organize, schedule, and facilitate the DSMB meetings

• Provide minutes and a summary of action items of DSMB meetings to the Sponsor in a timely fashion

• Establishing the CRO as a liaison between the study Sponsor and the DSMB

Align CRO’s established processes and SOPs regarding DSMB management ensure an independent oversight of clinical safety data for your clinical trial needs.