Module 12 Presentations

Efficiencies achieved

• EDC cuts 41% of pre-study preparation time in comparison to using paper CRFs • Use of “standardized” and submission focused eCRFs saves time on both ends of the process • Overall EDC saves on average 30% of the time it takes to conduct a clinical trial • Use of extensive edit checks prevent many incorrect data points from being entered

• Querying can focus on data inconsistencies and missing data programmatically

This is an area where ML/AI will have an impact (Day 3)

The Organisation for Professionals in Regulatory Affairs