How Long Is Your RTSM Risk Mitigation List?

While RTSM systems help reduce many of the risks in clinical trials, each trial’s unique setup necessitates customized risk assessment to address trial-specific challenges. IRT project teams at Perceptive utilize a systematic approach to risk analysis, which includes assessing a pre-defined list of potential risks based on previous trials, identifying new risks introduced by specific trial designs, and implementing mitigating actions. For high-severity risks, teams rely on their system design expertise and coordinate with study sponsors on additional mitigations.

Ongoing expertise is critical, as experienced IRT teams have insight into RTSM system capabilities and can effectively handle both familiar and novel risks. In the event of protocol amendments, which introduce new risks, the RTSM team conducts a refreshed risk analysis to maintain control over trial impacts. This continual assessment process ensures that risk management remains adaptive and responsive throughout the trial’s lifecycle.