Data Safety Monitoring Board For Nursing Home Trial

A large international pharmaceutical company was required to establish an external data safety monitoring board (DSMB) for a drug trial in a vulnerable, institutionalized elderly population. They approached us based on our research expertise and knowledge of the long term setting. We identified experts to serve on the DSMB, held regular meetings, managed data and verification of interim statistical analyses for expert evaluation, and prepared summary reports for the sponsor to meet FDA requirements over the 2 study years.

Key Services:

Clinical trial data safety monitoring board
Meeting management
Statistical analysis
FDA requirements