Jan 01, 2022
Has FDA required post-approval RCTs for orphan products in oncology approved based on single-arm studies?
Challenge
Search for all Orphan products.
Narrow the search results to those with oncology indication.
Narrow the search results to those approved based on single arms studies.
Identify whether RCT was a post-marketing requirement for each asset.
Outcomes
RIA helped regulatory experts to quickly identify all orphan oncology products approved using single-arm trials.
RIA further helped find whether RCT was a PMR for a specific subset of interest.
Why Vivpro?
RIA saves time and delivers intelligence at high quality EQUALS TO more time for strategy.
Vivpro RIA | Competition | Manual |
|---|---|---|
Time Efficient: Result in 15 mins | Less Time Efficient: Result in 1 day | Time Inefficient: Result in 3 days |
Top Quality Result: Human & Machine Assisted | Normal Quality: ResultMachine Assisted | Ok Quality Result: Human Assisted |