Module 12 2019

Efficiencies achieved

➢ EDC cuts 41% of pre-study preparation time ➢ Use of “standardized” CRFs 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 (eg legacy self evident corrections) ➢ Querying can focus on data inconsistencies This is an area where ML/AI will have an impact (Day 3)

The Organisation for Professionals in Regulatory Affairs