Safety Submissions & Distributions
Managing PSURs, DSURs, EdTs, and other submissions or distributions
Safety Submissions & Distributions
The CARA Life Sciences Platform supports the ongoing task of distributing safety information on a periodic basis to affiliates, distributors, and other third parties responsible for safety reporting to NCAs and tracking interactions.
Benefits
Distribution
Trigger workflows for distribution of safety data and documents to affiliates and distributors - manually, or automated from external partners
Documentation
Manage the creation, review, and approval internally of PSURs, SABR Signals, Educational Materials, and other aggregate reports
Portal Access
Distributors, affiliates, and other third parties can access CARA via a simple portal to acknowledge, submit and confirm required actions with Agencies
Tracking
Central regulatory affairs has a real-time view per-product and per-country of the status of safety document receipt, submission, and registration
RIM Integration
Integrate all the data and documents seamlessly with RIM and Regulatory Documents on the CARA Life Sciences Platform
Example Safety Distribution Workflow
Send for Processing
Acknowledge Receipt
Country HA Submission
Review & Process Comments
Confirm HA Submission
Distribute to HCPs
