SecureCHEK AI Accelerates Label Updates for Promotional Materials Speeds Materials to Market, Ensures Quality Control

Label updates can be a heavy lift for pharmaceutical companies and their promotional agencies which is why SecureCHEK AI offers an automated label update process using artificial intelligence.

FDA is authorized to require certain drug and biological product application holders to make safety-related labeling changes based on new safety information that becomes available after approval of the drug or biological product.  

Per the regulations, all assets must be promptly revised to be consistent with label changes, including new safety information that impacts assets and activities directed externally to customers including healthcare professionals, patients/consumers, and payers.

Typically, a company’s Regulatory department and the FDA will negotiate the wording/incorporation of the updated safety signal data for the label change. Then Regulatory, according to the agreed upon new label, updates and then revises the ISI, and other balancing or disclosure statements, etc. 

Once the updated ISI and other statements are finalized by Regulatory, the Project Owner/Brand with the advertising agency identify all the promotional pieces affected by the updated label changes.  Replacing the old ISI, disclosures and balancing statements can be time-consuming, costly and increase the utilization of resources, including time spent by members of the medical, legal and regulatory review team.  

With SecureCHEK AI, new ISI and disclosure/balancing statements are uploaded into the software and prechecked against a library of currently approved assets that need to be updated.  A Quality Assessment (QA) Report is produced that captures the locations and content deviations from the new ISI and disclosure/balancing statements The Report acts as a roadmap to ensure agencies correct the assets to reflect the new ISI and other required statement.  Finally, corrected assets are uploaded into the software for final confirmation that changes were properly made.  SecureCHEK AI has a specific functionality to address the unique requirements for the ISI, including format.

Schedule a label update demo so you can be prepared to cut execution time by more than half.