EDC Buyer’s Guide – Essentials

You’ve established your clinical trial protocol, and it’s now time to implement it into your electronic data capture (EDC) solution. How can you be sure that the solution you’ve chosen is best suited to completing this task with speed and ease? Let’s take a look at the EDC features that those involved with vendor selection should look for in order to optimize their protocol implementation, data entry, and more.

 

Form flexibility

Modern eClinical software users need a solution that offers speed and accommodates sites in various geographies. When it comes to building and deploying your electronic case report forms (eCRFs), here’s what that means:

  • Ownership and control – The more cutting-edge EDC tools today reduce costs and timelines by allowing you to build your own eCRFs with a simple drag-and-drop interface, without relying on IT or programming staff. You can also make mid-study changes without reaching out to your EDC vendor or taking your study offline.
  • Localization and standardization – Cloud-based solutions allow you to deploy new eCRFs by geography and site, helping you localize your work for language, measurement systems, and more – all at the click of a mouse.

 

All about your data

Now that your eCRFs are built, an ideal EDC solution offers modern features, impossible on paper CRFs or early EDC solutions, that create smarter processes for managing your data. These features accelerate data entry, monitoring, and more, all while maintaining quality.

  • Data quality – Soft and hard range checks ensure that you catch errors in data entry. Reminders ensure measures are taken consistently. And skip logic creates efficiencies by eliminating irrelevant fields – why enter packs per day, for example, if the subject is a non-smoker?
  • Monitoring – The ability to monitor data remotely, with no paper and in real time, will enhance detection of safety issues and adverse events as well as significantly reduce costs.
  • Reporting – Robust reporting functionality facilitates the collaboration necessary to proactively make necessary study changes. You can identify low-performing sites and other issues, and take the necessary steps to get everything running smoothly again.

 

What about the regulatory side?

In the evolving regulatory environment of today’s clinical trials, an ideal EDC goes beyond simple CFR Part 11 compliance. Here are some crucial regulatory offerings to look for:

  • Reduced validation burden – When changes to studies occur solely in the EDC database, with no effect on the code base, it eliminates the need for repeated database validation after each change. The ideal EDC offers this efficiency
  • A finger on the pulse – Today’s best EDC solutions stay on top of current events. This means awareness of recent regulatory changes such as the upcoming European privacy regulations, the effect of the rise of mHealth tools on FDA regulations, and more – and the ability to seamlessly adopt these frameworks into the software.

There are a lot of EDC solutions on the market today. It’s crucial to identify which ones offer the speed, flexibility, and feature functionality that today’s clinical trials demand.