Enhancing Traditional Site Visits with Risk Based Monitoring
To gain a competitive edge, one leading CRO enhanced its traditional services with risk-based monitoring.
Sponsors are expressing increased interest in risk-based monitoring (RBM). Given the complexity of databases and spreadsheets, however, they have a hard time addressing RBM on their own. CROs that can offer this service are gaining a competitive advantage.
The CRO understood that the traditional site monitoring services it provided could be enhanced by monitoring centralized data in real time. It needed a comprehensive solution that could be up and running quickly and used with multiple data systems.
The CRO implemented Saama’s Risk Based Monitoring solution across two studies. Shortly thereafter, five more studies were brought on board and the solution is rolling out to more studies on a regular basis.
The CRO has been winning new deals by explaining how Saama’s technology adds value to the RBM process. The CRO’s RBM teams have been catching more of the things they need to catch, while doing a lot less manual work. The software automatically sends alerts when core and protocol-specific KRIs are showing cause for concern, so team members can spend their time quickly responding to identified issues before they turn into more serious problems.
“There really isn’t another tool that can send alerts based on threshold breaches. This solution delivers exactly what we asked for and really matches well with our overall RBM philosophy.”—Senior Director of Global Study Management