The move to risk-based monitoring has prompted the need for new tools to enable the promised efficiency of this new paradigm.
By using TheraScan to centralize monitoring duties several possibilities are enabled:
Just in time SDV. With source document uploads at the time of data entry, risk-based algorithms can be invoked to determine which data elements need verification as they arrive. Monitors can immediately view the source document, even before committing the data, such that information is added to the clinical trial management system (CTMS) “pre-cleaned”.
Proactive monitoring. Monitoring data is collected in real time. Investigational product inventory, environmental data, shipping logs and the like are uploaded and processed by the system as it happens. Monitors, as well as the investigators, are alerted in real time to the status of the trial. Data can be cross referenced against the CTMS to gauge the effectiveness of the study sites.
Dynamic selection. Sites can be assessed dynamically such that monitoring guidelines can reflect actual site performance. As sites gain expertise they can “earn” a less frequent monitoring regime. Conversely, site that need additional attention can be quickly identified so that systemic issues can be addressed early on, thus preventing a cascade effect from compounding issues.