DM and Monitoring

Benefits of the Encapsia Conduct App

• Instant tracking, reviewing and cleaning of all clinical trial data: This is all done in Conduct, whether the data was entered via eCRFs in the Entry app, as electronic source data in the eSource app or as multimedia in the eSource app.
• Easier jobs for Data Managers: Once logged in to Conduct, you can select a mode that will guide you through a particular task. For example, you may want to find all the queries that you raised and acknowledge any of the sites’ responses. Or perhaps you are performing safety reconciliation on all events that have been categorized as serious.
• Complete overview of data and their history: Within Conduct you have a full set of comprehensive supporting information for each data point. You can see queries, tags and the current state of all reviews clearly displayed on screen, along with the signature and lock status. If you have the appropriate access levels, you can access multimedia attachments that have been added by site staff and clicking on a data point displays its complete history, showing not just the audit trail information but every event that has occurred in the lifecycle of the data.
• Increased and live collaboration amongst study team: You can view all open and historic queries and responses in Conduct and you can raise new manual queries too, which appear immediately in the relevant Encapsia data entry environment, be that Entry or eSource. And when site staff respond to queries, their responses are immediately visible in Conduct.
• Effective issue management: An intuitive project management platform, Encapsia allows trials to be set up with multiple levels of review called tracks. Each track is used to define a subset of the data for review by one or more roles with particular functions. Tracks can be used to select data for SDV, SDR, eligibility review or any other review task. As data is entered, data points are automatically flagged as “To Do” items in any tracks they’re associated with. Users with the responsibility for monitoring a given track can easily see the data points requiring their review