The protocol transparency report
When regulators ask:
"How did your AI reach this recommendation?"
Can you explain it clearly, defensibly, in plain language?
If not, you're paying for it. Literally.
What's at risk:
$400K per protocol amendment
6-12 months of timeline delays
Permanent regulatory scrutiny on every future submission
More than 57% of trials face at least 2 amendments.
How many could be avoided with transparent, defendable AI?
Inside this 6-page report:
The 4 pillars of AI credibility EMA & FDA now mandate
3 real scenarios where black box AI triggers $400K+ amendments
5 questions regulators will ask, with red flag vs green flag examples
Your regulatory readiness checklist (use before your next submission)
Based on 560,000+ clinical trial protocols and official EMA/FDA guidance.
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