The customer had previously performed all their clinical trial monitoring using Excel as a tool, requiring extensive manual and labour-intensive processes. For a high-profile study, the customer had implemented a new Electronic Data Capture system (EDC), but this system had no automatic data extraction module. The customer was therefore facing challenges managing and analyzing their data on a regular basis.
When conducting a clinical trial, there are many regulatory demands that must be met in relation to how the oversight of the trials is being conducted and subsequently documented. For each trial there can be many different elements that the sponsor of the trial must ensure are completed and not violated. This can both be at a patient level (e.g. ensure that all patients attend the mandatory visits) or at site level (e.g. ensure that all sites comply with the rules for entry of patient data). This poses significant demands on medical monitors and requires real time monitoring which is not possible in Excel.
Our solution enabled the client to fully automate their data extraction from source systems and reduce the manual interactions required. The trial teams’ reliance on the IT department was lowered and they can, to a certain degree, make their desired setup and configurations. The solution helps the customer to increase data quality and compliance through an intuitive and visually appealing user interface. At the same time, it ensures that the users can document the trial oversight and related activities.
The solution helps the customer to increase data quality and compliance through an intuitive and visually appealing user interface. At the same time, it ensures that the users can document the trial oversight and related activities, thereby meeting regulatory requirements.
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