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Safety tips

Best Practices for EDC:

When evaluating vendors, make sure you have a good understanding of their entire capability. The answer to a problem is rarely technology alone so you’ll want to understand their service offerings, their expertise in specific areas (either therapeutic areas or services) as well as their reputation for customer service.

Be practical. Some vendors demonstrate all of the bells and whistles of a system that aren’t necessary or are rarely used during a typical EDC study. Don’t be distracted by fancy features. Think about your daily duties and how you want a technology to impact them. These fancy features may seem really cool, however come at a price of both time and money!

Consider your ability to access data throughout a trial. The ability to export data in real time or view a standard report can save significant time and money. It may sound simple but the cost savings can add up quickly and can significantly impact your ROI.

Understand where the EDC company fits into your clinical program. What support will they offer in terms of trial design, submission compliant deliverables and quick top line tables after database lock?

Put yourself in the shoes of each of the roles for your clinical trial (CRA, Data Manager, Sponsor, Study Coordinator, Investigator). Does the system have the features and functionality needed to easily and properly perform the tasks for that role?

Remember-study coordinators will adopt a system which is easier to use over one which requires extensive training and is cumbersome!

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