Series: Selecting an EDC Part I
posted: September 9, 2016
by: Brian Olender
Selecting an Electronic Data Capture (EDC) vendor and system is a daunting task. This is true for sponsors choosing systems in a study-by-study model where there is a desire to optimize the solution for each study. There are a number of important considerations to take into account when selecting an EDC solution for your clinical trial. The next few weeks we will discuss these topics.
It is always important to consider the experience of your study team (internal and sites).
If your team has experience with a certain EDC solutions, include these solutions in your evaluation process. Training can be a significant time and cost commitment. Experience will reduce costly and time-consuming study build and startup activities associated with EDC by allowing the team to rely on resources.
Surveying key sites can also prove valuable to gauge if sites have had positive experiences with certain systems. This understanding can help to gain commitment from other investigators and sites.
Mid-study Changes and Amendments
Considering the impact of mid-study changes is of vital importance in the EDC selection process. This can often be the most costly and time-consuming aspect of running trials in EDC.
If there are multiple protocol amendments or other mid-study changes, the related costs, time, and effort can be significant and disruptive to study conduct. Part of your evaluation should consider how the system supports and rolls out mid-study changes within EDC. Some EDC systems while providing almost limitless study design options can be quite cumbersome when updating the system.
The same considerations should also be applied to adaptive study design.