What is Integrated Risk Based Monitoring (IRBM)?
Integrated risk based monitoring is a process, where all participants of a clinical trial are involved: training department, audit, clinical trial operations, and management. Everybody is united into the highly efficient team. Clinical trial is better managed, better conducted and costs are reduced.
Specialized software system EarlyBird® makes an everyday analysis on the clinical data. It is like a “virus scanner” runs on clinical data and detects data anomalies and early risk indicators.
It notifies the appropriate group and provides an action plan – best practices from industry which can be taken and implemented. EarlyBird captures the real actions, which are taken and provides a real trace risk report at the end of a clinical trial.
EarlyBird® has a specialized level of escalations, in order to avoid the noise and inform “big people” only with “big things”.
The Cyntegrity team helps you in implementing the IRBM for your organization. It applies the change management methods for all the participants: sites, clinical monitors and study managers. We are passionate to help you to tune your efficiency. A specialized report about the improvements and saved costs(estimated) is prepared at the end of each clinical trial.