Data Safety Committee Establishment and Management

Oversight committees are a critical element to the efficient execution of a significant risk device trial including a Clinical Events Committee (CEC) and Data and Safety Monitoring Board (DSMB). Accordingly, BBA has developed a process for establishing and managing the smooth and consistent operation for both CECs and DSMBs.

Our staff is highly adept at establishing and managing safety monitoring and clinical event committees for adverse event adjudication and interim study reviews.

Services include:

  • Identification and qualification of committee members
  • Meeting preparation, execution, and documentation
  • Clinical data summary and report generation

Our results-proven, turnkey programs and templates help ensure quality data safety monitoring critical to many clinical trials.

 

Contact Us
Call our Massachusetts office at 866-351-8632 (In MA 508-351-8632)
M-F 8-5 eastern time or e-mail us and we’ll contact you directly.



BOSTON BIOMEDICAL ASSOCIATES
386 West Main Street, Suite 7 · Northboro, MA 01532
Tel. (508) 351-8632 · Fax: (508) 351-8637

©2007 Boston Biomedical