Attention Sponsors, Be Prepared to Publish Your Interim Clinical Study Results
Starting January 2022, European regulations will mandate sponsors to publish interim clinical trial results, enhancing transparency. This requires capturing and reporting interim analysis dates accurately, with phase 1 results due within 30 months and later phases within 12 months post-analysis. Automation in data management and reporting is crucial for compliance.
Reference News
Attention Sponsors, Be Prepared to Publish Your Interim Clinical Study Results
Starting January 2022, European regulations will mandate sponsors to publish interim clinical trial results, enhancing transparency. This requires capturing and reporting interim analysis dates accurately, with phase 1 results due within 30 months and later phases within 12 months post-analysis. Automation in data management and reporting is crucial for compliance.