Risk Summary & Gap Analysis (Step 9)

Overview

Step 9 synthesizes all clinical evidence and safety data to perform benefit-risk assessment, identify clinical data gaps, and provide post-market monitoring recommendations. This is the final analytical step of the clinical evaluation workflow.

Generated Content

Benefit-Risk Assessment

• Clinical benefit summary
• Identified risks summary
• Benefit-risk comparative analysis
• Overall benefit-risk conclusion

Gap Analysis

Identifies deficiencies in existing clinical evidence:

• Clinical data gap identification
• PMS/PMCF requirement analysis
• Additional clinical study recommendations
• Final benefit-risk conclusion
• Clinical evaluation update frequency recommendation

Equivalence Argumentation (if applicable)

If the Equivalence pathway was selected in Step 8, Step 9 includes:

• Technical equivalence analysis
• Biological equivalence analysis
• Clinical equivalence analysis
• Equivalence conclusion and limitations

Workflow

1. AI synthesizes results from all previous steps to generate risk summary and gap analysis
2. Review benefit-risk conclusions
3. Confirm PMS/PMCF recommendations
4. Approve to proceed to document generation

Next Step

After all 9 steps are complete, proceed to document generation:

→ Generate Documents (CEP/CER/DCR)