Portfolio compliance
80
Composite score across 6 studies · ICH E6(R3), 21 CFR, EU CTR
3
Critical
4
Major
2
Minor
Top inspection risk
Predictive risk trend: Site 014 (Klinikum München, ARCADIA-3) is projected to cross into Red within 3 weeks at current pace. Historical pattern suggests coordinator turnover — consider unscheduled monitoring visit.
Study × Standard
Click any cell to drill in
| Study | ICH E6(R3) | 21 CFR Part 11 | 21 CFR Part 312 | EU CTR 536/2014 | 21 CFR Part 50 | MHRA GCP |
|---|---|---|---|---|---|---|
ARCADIA-3 Phase III · Type 2 Diabetes | ||||||
HELIOS-2 Phase II · NSCLC | ||||||
ORION-1 Phase I · Rare Genetic | ||||||
VELA-2 Phase II · Ulcerative Colitis | ||||||
AURORA-3 Phase III · Atrial Fibrillation | ||||||
MERIDIAN-2 Phase II · Psoriasis |
CRO oversight — delegated obligations
- Meridian CRO4 studies · 8 sites72
- Ivory Clinical2 studies · 3 sites80
- Pacific Trials1 study · 1 site88
Safety reporting timeliness
SUSAR (7-day)22/24 · 92%
SUSAR (15-day)38/38 · 100%
DSUR (60-day)5/6 · 83%