The Top Line:
- Today's EDC platforms are more scalable and powerful than in years past.
- Innovative billing structures allow researchers of any size to use EDC.
- The FDA encourages EDC adoption.
The popularity of EDC (Electronic Data Capture) continues to grow throughout the clinical research sector. EDC technology now is common not only in large pharmaceutical trials, but also in smaller biotechnology and device studies. At the same time, though, a number of small sponsors and clinical research organizations (CROs) believe EDC is still beyond their budgets and continue to enter paper Case Report Forms (CRFs) into electronic databases (double data entry). They also often enter paper CRFs into spreadsheet programs like MS Excel® for trials where submission to the FDA is not the ultimate goal.
But the evidence is clear: recent advancements in EDC technology combined with new pricing models have put EDC within reach of virtually all clinical researchers for all sizes of studies. And it’s clear that the more open and immediate collaboration and data access EDC fosters among sponsors, regulators and CROs through electronic communication reduces research costs and helps bring safer, more efficacious products to market sooner.
So in an industry that’s evidence-based, what are the facts supporting EDC adoption?
EDC is Faster
Cloud-based software offers everything CROs and sponsors need to develop and execute studies more quickly and successfully. Efficiencies are gained every step of the way, from data transmission and cleaning to data monitoring and reporting. Furthermore, the days when building databases with EDC took months and months are long gone. Today’s digital tools let you design and launch trials much easier and much faster (sometimes in as few as 10 days, in fact). Databases can be created without the intermediate step of building paper CRFs first.
EDC is More Accurate
Optimizing trial management through technological components such as digital identities, digital signatures and cloud storage makes collection, retrieval and review of clinical data easier, effective and better managed. A single system that collects and stores all your data assets (e.g., eCRF data, images, PDF source documents, etc.) saves time by enabling you to search the data in a clinically meaningful context and store it all in an organized manner. Further, EDC platforms help ensure data accuracy at the point of entry through automated edit checks that alert you to potential errors immediately.
EDC is More Cost Effective
The productivity gained by eliminating the countless hours spent searching binders to file or retrieve one document (much less several hundred) is a well-known advantage of EDC. But early EDC systems that required steep upfront infrastructure investments and long-term contracts put such advantages out of reach for many researchers. Today many cloud-based platforms allow you to use only the tools you need, when you need them. With this “pay-as-you-go” option, EDC technology now can be leveraged for trials of all sizes. Some systems let you customize the blend of features you need and pay based solely on what you use and how long you use it.
EDC Means Data Portability
You can access today’s cloud-based EDC platforms with any Web-enabled device, and the software will automatically optimize your interface to match your tablet or smartphone. The systems are validated against the most frequently used Web browsers, and some vendors even allow you to create customized alerts that help you stay on top of study data and changes. As in other aspects of your life, you are no longer tied to your desk to conduct work; you can take your study and all its data with you wherever you go.
EDC is Global Trial Friendly
Because many cloud-based platforms allow users to select their native language for system navigation and CRF display, it is much easier to collect data on one common platform across all sites, regardless of location. Some vendors also incorporate “features of convenience” that automate the process of source document translation so team members who speak different languages can collaborate more easily.
The FDA Supports EDC
Years ago, the FDA expressed concern that EDC technology might conflict with long-standing rules and regulations. That caution led many researchers to forego adopting EDC. Well, the days of “EDC foot-dragging” are long gone. In 2013, the FDA released Final Guidance on Electronic Source Data in Clinical Investigations in which the agency outlines EDC’s many benefits and encourages its adoption. If you haven’t read the report yet, it is definitely worth your time.
In 2015, access to affordable, powerful, scalable and secure data management platforms is growing. Technology that once may have been too pricey for smaller trials or research groups is now available at a fraction of the cost. If it’s been a year or more since your organization last reviewed EDC options, that is an investigation worth conducting.
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