When it comes to selecting an EDC vendor, it seems that most vendors fall into one of two categories: advanced technology and competitive pricing or moderate to baseline technology at a low cost. While budget is a major concern for most Sponsors, how can they be sure they are choosing the right technology to produce the best study results? ARITHMOS has put together a cost vs functionality matrix followed by a list of considerations for selecting an EDC system for your next study.
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1. Cloud-based Technology
An EDC solution provided in Software as a Service (SaaS) cloud computing mode can improve the drug/device development process in terms of greater efficiency, a better decision-making process and cost-cutting measures. Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. A cloud solution can organize multi-language, global study data into a single database, improving the quality of data through automated edit and discrepancy checks and faster data cleaning.
2. Support Level
What is your ideal level of support for an EDC system? The more advanced systems provide excellent initial training programs and top level support through HelpDesk and study guidance. The baseline technology systems allow the Sponsors to work more autonomously with regards to study build and management. However, in this case the user interface needs to be intuitive and easy to navigate.
3. Hosting and Licenses
Consider how you will manage the EDC license and hosting options. Some systems include this in an inclusive package and others will provide various “à la carte” options.
4. Integrated Platforms
Some EDC systems are part of a larger integrated platform for seamless data integration among ePRO, CTMS, IRT and other clinical research systems. Falling into the advanced technology, competitive pricing category, an integrated system may be worth the investment for your program of studies.
- Can you build your own study?
- Are there data entry, coding and randomization features?
- Are there Project Management tools?
- Are there customized reporting features?
- Are there re-usable templates and forms?
- Is the system compatible with GCP and/or regulatory guidelines? Is there an audit trail?
- Can the system handle multicentre, global studies?