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

All studies

All studies

Showing 22 of 22 risks across the portfolio.

Risks by severity

Critical1 risk

Title	Owner	Study	Status	Mitigation
Sample size insufficient at current event rate	Biostatistics Lead	RARE-007Northwind Genetics	Open	Type B FDA meeting requested to discuss adaptive SSR; protocol amendment v4 draf…

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…

Medium9 risks

Title	Owner	Study	Status	Mitigation
Higher than expected screen failure on creatinine clearance criterion	Medical Monitor	ONC-002Acme Therapeutics	Open	Protocol amendment v3 in draft to relax CrCl from 60 to 50 mL/min.
Central lab assay validation re-run required after method update	Lab Lead	VAX-014Stellis Vaccines	Open	Re-run scheduled; analytical bridge plan agreed.
CSR authoring vendor capacity over Q1 2027	Medical Writing Lead	CV-118Helios Cardio	Mitigating	Backup author identified; CSR shell pre-built.
Single-source device component supply	Supply Chain Lead	DERM-003Lyra Skin Sciences	Mitigating	Buffer stock at 3 months; second-source qualification in progress.
Vendor archive handoff for 6-year retention obligation	Records Lead	OBS-PMR-001Veridian Pharma	Mitigating	Long-term archive contract executed; index re-verified.
CRO sub-contracting central lab going through M&A	CRA Manager	ONC-002Acme Therapeutics	Mitigating	Continuity letter on file; back-up lab identified.
Central reader inter-rater variability above threshold	Medical Monitor	RARE-007Northwind Genetics	Mitigating	Retraining and re-adjudication of 12% of reads in progress.
IRT vendor outage on 2026-04-12 caused 14 mis-randomisations	Data Management Lead	RARE-007Northwind Genetics	Closed	Vendor RCA delivered; all subjects reconciled; CAPA closed.
Reactogenicity rate slightly above comparator	Medical Monitor	VAX-014Stellis Vaccines	Closed	Independent DSMB review at 50% enrolment: continue unchanged.

Low8 risks

Title	Owner	Study	Status	Mitigation
Event rate slightly below DSMB-projected curve	Biostatistics Lead	CV-118Helios Cardio	Mitigating	On track per pre-specified contingency; LPLV trigger by event count, not date.
Long-tail subject retention in Eastern Europe	CRA Manager	CV-118Helios Cardio	Mitigating	Retention stipend uplift approved; LTFU still 3.1%, below 4% threshold.
CE-mark renewal aligned with EU MDR transition	Regulatory Lead	DERM-003Lyra Skin Sciences	Mitigating	Notified body engaged; renewal dossier on track for Q4 2026.
Publication concurrency with sponsor PR cycle	Medical Writing Lead	OBS-PMR-001Veridian Pharma	Mitigating	Joint editorial calendar agreed.
Seasonal enrolment dip projected through Q3	CRA Manager	VAX-014Stellis Vaccines	Mitigating	Southern hemisphere sites in start-up to offset.
Subjective endpoint reader drift	Medical Monitor	DERM-003Lyra Skin Sciences	Closed	Calibration sessions every 90 days; QC audit at 50% enrolment passed.
Late-arriving AE narratives at DB lock	Pharmacovigilance Lead	OBS-PMR-001Veridian Pharma	Closed	All narratives QC-cleared; lock executed without amendment.
Investigator turnover at top-3 enrolling site	CRA Manager	ONC-002Acme Therapeutics	Closed	Sub-investigator certified and trained.