We provide independent safety monitoring for neuro-oncology trials, combining automated safety signal detection with DSMB support and access to a network of clinical experts.
Safety Monitoring Portal
We offer a study-specific safety portal that tracks reported adverse events and flags deviations from expected rates, benchmarked against a reference database and historical GBM studies. Alerts are stratified across clinically relevant subgroups.
DSMB Charter and Set-up
We set up and coordinate Data Safety Monitoring Boards for your trial, managing membership, meeting logistics, and the operational framework within which the board functions. We also prepare the DSMB charter, covering meeting frequency, stopping rules, statistical guidelines, and board member responsibilities. Safety listings are prepared in close collaboration with one of our consultant MDs, who also presents the safety data at DSMB meetings, giving the board clinical context alongside the numbers.
Expert Network
We maintain a network of medical experts available for consultation on complex safety questions, providing independent clinical input when needed.