1) What is electronic data capture (EDC), and what does it do?
EDC is typically towards the latter part of a clinical trial project. It’s the point at which you are running a trial and you’re collecting clinical data on your subject. The electronic version of the data capture helps steed that data collection, helps ensure that it is accurate and helps ensure that preventable errors and data problems are not entered into it. It can also ensure that intentional fraudulent data is not entered, or is caught as fraudulent. It helps in having captured the data, to export it and format it in formats that are required for submission to the FDA.
2) How is the Cloud a safer, more stable environment for hosting student data and clinical trials?
With traditional EDC platforms, the clients typically downloaded an application onto their own equipment and servers, and ran the app themselves, supported it with their IT staff, etc. More modern EDC systems are built for use on the Cloud. Why that is safer is because there are environments that built these Cloud environments by large companies like IBM and Amazon, etc., where there are platforms for hosting and running applications. In doing so, they have built very standard packages of software and hardware, middleware and platformware to run it. These systems have been embedded against each other and then run on into clad systems that are harder to penetrate by hackers or accidentally by users.
3) Why might Cloud EDC be the best choice for multi-site studies at universities?
Trial data is often hosted in a location and in a way where authorized users, regardless of their geography, can access it. In many cases, trials that are run are multi-site, and by virtue of it being a Cloud-based system, that data can be collected centrally regardless of them being geographically disparate… Where you have multiple sites, the key is you can work collaboratively. Historically, if you have another EDC site, you’re probably collecting that data at each site, and then collating that information or merging databases, etc. Naturally, in a databased system, all of the data is collected centrally. None of the sites, therefore, are responsible for safeguarding the data themselves, which can be a problem with uniformity. But in a Cloud-based system, that is done centrally either by the hosting vendor of centralized administrator or sponsor of that study.
4) What tips would you suggest to colleges that are looking to move to EDC?
For any college, university, or research center that is going to do a trial, the typical thinking is that they’re just going to do the data capture on paper. Historically, it was because the cost and complexity of using an EDC system [was too high], and they really couldn’t use it for something that small. Now, with Cloud-based EDC systems, it is significantly less expensive to use an EDC system than it is to capture data on paper. Do not do it on paper – you must use an EDC system regardless of the size and length of the trial. Not only is it going to be faster than creating that on paper, it will save them a lot of time and effort up front. The biggest savings will be from the lack of data errors they catch and record on the fly that otherwise would cost tenfold going back to chase down and correct those errors.