Cross-study view

Platform Risk Register

Every cro.study_risk row in one filterable view. Counts below reflect the full platform; filter to drill into a single study, severity, or owner.

17 active · 1 critical · 4 high · 9 medium · 8 low · 5 closed

Filtered view

Filtered view

Showing 4 of 22 risks across the portfolio.

Risks by severity

High4 risks

Title	Owner	Study	Status	Mitigation
EAC has breached contracted budget	Finance Lead	RARE-007Northwind Genetics	Open	Change order in negotiation; sponsor steering committee notified.
EU site activation delayed by competent authority backlog	Regulatory Lead	ONC-002Acme Therapeutics	Mitigating	Escalated; two replacement US sites in qualification (target activation +45d).
Patient identification network exhausted at top 5 sites	Feasibility Lead	RARE-007Northwind Genetics	Mitigating	Expanding to APAC region (3 new countries); RWD partnership signed.
Manufacturing lot deviation on adjuvant lot ADJ-2025-04	CMC Lead	VAX-014Stellis Vaccines	Mitigating	Lot quarantined; re-qualified replacement lot deployed; CAPA in regulatory revie…