Clinical trial monitoring is in need of streamlining. Traditionally much of the data within clinical trials is collected directly on paper and entered into an Electronic Data Capture (EDC) system, which can lead to a delay in trial analytics and metrics by two to three months, with the sponsor being largely unaware of the trial’s progress. Delays in metrics traditionally will trigger trial visits by monitors to rectify issues, with trial sites frequently overwhelmed.
There are a number of vendors who currently offer plug in solutions that require considerable configuration further adding to trial budget. We here at Quanticate offer a real time data aggregation, analytics and collaboration platform for clinical trials. We do this by collecting trial data and storing it in a HIPAA compliant server.
With this real time analytic there is a reduced need for frequent site visits by trial Clinical Research Associates (CRAs), they can now monitor parts of the trial remotely, and resolve and issue queries via the same platform. This translates to immense improvements in quality, reduction in time to submission and potentially a cost saving in monitoring budget.
Our approach combines aspects of Remote Source Data Verification (rSDV), Remote Monitoring, Centralized Monitoring and Advanced Visualizations, optional with Risk Based Monitoring. Unlike some pure-Technology providers, instead of offering a disjointed set of pieces, Quanticate delivers a proven complete service offering to solve your monitoring needs. By approaching monitoring from a data perspective, rather than one based on expensive bodies-on-the-ground, Quanticate's rSDV platform delivers higher quality monitoring with cost savings.