Although this process change can be difficult, companies engaged in clinical research have smart employees who are well able to see the benefits of EDC and who are willing to make the necessary adjustments to maximize its potential.
But if the people are flexible, the existing computer systems normally aren’t. How will your new EDC system work with your Clinical Data Management System (CDMS) or with your eSubmissions system?
The typical clinical trial is reliant on a number of computer systems. These systems may be internally developed or vendor supplied. Making these systems talk to each other—in such a way that Serious Adverse Event (SAE) data can be reconciled between your CDMS and your SAE Reporting system—can be a major project for your IT group. It can also be a significant expense if you outsource that work to consultants. For these reasons, any project that introduces new technology into the clinical trial process normally includes a thorough review of its compatibility with the existing systems.