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Risks by status
Filtered viewShowing 8 of 22 risks across the portfolio.
Risks by severity
| 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. |