Tuesday, August 28, 2012

How can data management professionals overcome issues with integration and real time data access?

The impact of eSource on the Data Management team can be significant, especially as it relates to infrastructure and workflow. Make sure to hear Evonne Roberts, Director of Business Development of assisTek speak about how your data management team can benefit from transitioning from paper CRF to an eSource solution and the implications of the FDA eSource guidance.

Over the next few weeks, we'll be featuring some of the topics discussed in the podcast the CBE team recorded with assisTek.  Today's featured question:

How can data management professionals overcome issues with integration and real time data access?
Evonne's answer: You know, the challenges associated with integration into existing systems are definitely an interesting one. The approach that we’ve taken is to work directly with the EDC vendor that the sponsor is trying to use in a study and create data files from the eSource solution that are automatically imported directly into the EDC system itself. This simply means that the data collected as an electronic source on a mobile device, for example, is also available to the study team in the EDC system for their review.
As far as real-time data access is concerned, this is the obvious expectation of the data management team when they use an eSource solution. However, it can get tricky. For example, if a site is using an eSource solution, they are collecting the data at the point of care. This means that the instrument, whether it is a computer or tablet, needs to be available whenever and wherever a patient is being treated. If the system requires Internet access, then that must also be available at all times (which is easier said than done in many global, clinical settings). A workaround for this is to use a custom application on a tablet, for example, which does not require Internet access to capture data. Being able to capture data without Internet access is a significant benefit and avoids sites mixing modes and falling back on paper when Internet access is not available.

For the complete podcast, download the audio and the transcript here.

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