When EDC was born in the 1990s it was supposed to replace paper and revolutionize data capture. But, rather than displacing inefficient processes, EDC merely added another. Even now, more than 20 years later, the dominant paradigm is for data to be collected on paper CRFs and then transcribed into an EDC system. The gap between a patient attending a visit and the data being available for visualization can be weeks.
But the world has moved on and it’s time to harness the technological advances that have occurred since the emergence of EDC. The internet, wireless networks and mobile devices give us the ability to live our lives online and on the move. Why should clinical trials be any different?
Encapsia® eSource is an iPad app, available from the Apple App Store. You download and use it just like any other app - it doesn’t require a special, locked-down device or involve costly provisioning. A simple, intuitive workflow allows you to enter data in real time during the patient visit. The data is automatically saved to an encrypted store on the iPad and, via the Internet, to the cloud-hosted encapsia® server.
The App works seamlessly online and offline, meaning it can be used anywhere, even in areas where Wi-Fi is intermittent. Validation checks fire at the point of entry, so you can see any errors while the patient is present and have a chance to make meaningful corrections. As well as improving protocol compliance this helps to ensure that your data is clean first time, reducing the number of queries from CRAs and Data Managers and the time it takes to resolve them. And not having separate source documents reduces or eliminates SDV.
Encapsia® eSource. It’s about time.
The eSource app is part of Cmed’s encapsia® clinical data suite, the first cloud-based suite of apps for the collection, management and analysis of clinical trial data.
With the eSource app, sites can capture source data directly on an iPad and the need to transcribe data from the notes to the eCRF is gone. With instant validation and clean data while the patient is still in the clinic, eSource is fundamentally a new way of doing things!
The eSource app is just one of the many game changing apps available in the encapsia® suite.
Fitting in at site
Learning anything new can take time. The eSource App is designed to be as flexible as possible so that it will fit with the site process.
- Source forms can be designed to collect site only source data that does not typically get entered into the CRF, allowing sites to collect all of their data in one place.
- Sites can use the iPad camera to attach photos or use the microphone to dictate notes directly alongside the clinical data.
- There is no limit to the number of iPads a single site can use, and there are no limits to the number of users that can share an individual iPad.
Let's talk advantages
What can encapsia® eSource offer you?
Sites directly capture all data into our user friendly eSource app, speeding up data collection and eliminating the need for transcription.
Wifi never seems to reach all corners of every building. With encapsia® eSource, this doesn't matter. It works just the same offline as it does online
What good is direct data entry, if you can't alert users to incorrect data? encapsia® eSource includes point of entry checks that fire at time of data entry.
The multimedia function enables data capture of authenticated copies of source data e.g. source notes, traces, EMR screens.
Perform all tasks in the app, including responding to queries
The audit trail for each datapoint contains the full lifecyle of the data, including its values, queries, signatures and lock status.