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lifecycle

Stage 31 · reporting

Regulatory Reporting

What this stage does

The continuous stream of obligations a sponsor owes regulators and ethics committees while a trial runs and a product lives: DSURs, periodic benefit-risk reports, amendment notifications, and registry updates, each on its own clock.

Where AI applies

Tracking every obligation's due date across the portfolio, assembling report drafts from the underlying safety and operational data, and consistency-checking across documents that must agree with each other.