An EDC budget cannot be justified for every study. However, simply because you are not using an EDC doesn’t make the data any less important. If a study is being conducted, it is being done so for the collection of data. There can be no afterthought regarding the collection or integrity of data. This is the motivation behind the TrialSTARTER package.
It is intended to provide a solution where a robust EDC implementation utilizing TrialBLAZER cannot be justified due to the study budget and scope. For example, there may only be 5 patients enrolled, such as in a First In Man (FIM) study or the study may be a single site physician initiated study.
A TrialSTARTER database package offers the unique advantage that it can be seamlessly migrated into the robust TrialBLAZER infrastructure when your organization is ready to expand the scope of your trials. It puts you ahead of the learning curve for adopting EDC within your organization.
This depends on the type of study, the objective, and the budget. Factors to consider are:
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