The Top Line:
- Reach out to the industry to learn about available systems.
- System pricing runs the range, as do productivity savings.
- Full-featured product demonstrations let you drive before you buy.
When it comes to selecting an EDC provider, your choice will depend on a range of factors and needs. Usage requirements to efficiently perform the functions and tasks required for successful project delivery, and your budget, will be prominent decision points. But where to start?
Even with the plug-and-play operability of SaaS systems, three steps can guide your assessment and help shorten the time between thinking about system vendor options and executing your first study
Like practically everyone else researching a product or service, the first place you’ll turn to for insight about EDC providers and systems will be the web. But simple queries are just the beginning. To support your search, look at objective webinars; see what companies are attending trade shows, and peruse annual buyer’s guides.
For other people’s knowledge, impressions and experiences, LinkedIn Groups is a ready resource that can help you locate EDC specific content and insight. Three highly active groups where you can ask members about EDC and clinical research are Clinical Research Professionals, Association of Clinical Research Professionals and Electronic Data Capture.
In addition to your research, it’s often helpful to ask colleagues both in and out of your organization what systems and companies they’re familiar with.
Bare bones technology or bells and whistles functionality? EDC systems run the range.
CROs, sites, sponsors and AROs are similar in that they conduct studies, but the size and kinds of studies they run, depending upon markets and therapeutic areas, will be different. When considering EDC systems, be sure to look at your end-user requirements and scrutinize the high-level system necessities you must have.
When determining your budget, keep in mind the pay-as-you-go option. You’re looking to cut costs, but this doesn’t mean choosing the cheapest EDC system on the market. Transitioning data to the new system, data security and expected savings over time between the old and new systems are factors. Ultimately determining the EDC budget should be based on a cost-benefit analysis of the system’s functionalities versus the study’s needs.
Another potential cost-saving consideration is IT. Business in general is becoming more reliant on the cloud and less dependent on traditional IT hardware and software installation and maintenance. Cloud-based EDC offers greater automation of IT activities with simplified updates and upgrades. But something else is also becoming simpler: IT department involvement.
With a reduction in maintenance and monitoring, participation by IT is diminishing and changing. As ECD evolves, IT professionals will have diminishing contribution in building study designs, allowing the clinical professionals to function more independently, and, as a boost to productivity, reducing personal and their associated time involved with studies. It also reduces vendor involvement. Users will be less dependent on help lines, which for some EDC vendors, is a lucrative profit center.
Words on a website are one thing. Playing under the hood is another. After comparing systems, take the ones you’re considering for a test run. System sandboxes are where you can experience a system first hand and get a feel what it’s like to live with it every day.
The demo should offer the full user experience as if you were running an actual study. Must-have features in today’s indispensable EDC feature set include data entry, coding and randomization features, project management tools, customized reporting features, reusable templates and forms, compatibility with GCP guidelines (and all applicable regulatory guidelines, of course) and the ability to handle data from multiple sites across the globe.
Every capability and service should be represented, not a stripped-down version. The extent that you test should be up to you. And always look for strings that should never be attached.
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