We would be happy to be your partner in the design and development of an Integrated Risk Based Monitoring (IRBM). We provide service and system for data-driven risk identification during clinical trials. Having control on risks is crucial for the success of a clinical trial and increases the likelihood of obtaining FDA/EMA approval.
Cyntegrity’s Approach:
In a conventional approach, statistical data analysis happens mostly towards the end of a clinical trial, when the problems are hard to fix, additional costs are already generated and deadlines are usually passed.
Cyntegrity provides a constant statistical monitoring of a clinical trial during the whole duration of your study.
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 a highly efficient team.
Our specialized software system EarlyBird performs a continuous analysis of clinical data. It is like a “virus scanner” that runs on clinical data and detects data anomalies and early risk indicators.
EarlyBird has specialized levels of escalation in order to avoid noise and inform decision makers only about a real danger. It notifies the corresponding groups and provides action plans based on the best practices from the industry which can be adopted and implemented. EarlyBird captures the actions taken and delivers a real trace risk report at the end of a clinical trial.
Cyntegrity Team helps you to implement IRBM in your organization. We apply change management methods for all participants of your trial: sites, clinical monitors and study managers. We are passionate to help you in tuning your efficiency. A specialized report about the improvements and saved costs is prepared at the end of each clinical trial.
Interested in learning more about Cyntegrity and our services?