In-trial
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Risk surveillance across the portfolio · 32-rule alert engine · KRIs · QTLs · runs every 60s
Active alerts
3
2 new · 1 ack
Tier 1 / 2
1 / 2
critical & high severity
Studies monitored
8
3 flagged at risk
Cost-of-delay/mo
$64.3M
across at-risk studies
Alert inbox
Tier 1-4 · routed by personaTier 1EnrollmentCSL-HEM-021·Fired 13h ago · New
Enrollment at 67% of plan — Site 47 trending lowest
Cumulative enrollment 98 of 147 planned. Site 47 (Dr. Mehta) at 12% of site target; 3 sites in DE/UK below 50%.
Continuum's investigationRisk Investigator · Sonnet 4.5
Root-cause hypotheses (ranked by confidence)
1.
Site 47 principal investigator (Dr. Mehta) experiencing competing gene therapy trial enrollment at same institution reducing referral pipeline
·Site 47 enrollment 12% vs. study mean 67% represents 5.6σ deviation from expectation
·Gene therapy trials typically compete for narrow hemophilia A patient pools at specialized centers
·Site performance degradation pattern consistent with PI bandwidth constraints rather than regulatory or site infrastructure issues
72%
confidence
2.
DE/UK sites (S-1112, S-1089) delayed by post-Brexit regulatory alignment requiring additional ethics submissions and extended patient consent processes
·Three European sites clustered below 50% threshold suggests regional rather than site-specific barrier
·Gene therapy trials face heightened EU regulatory scrutiny since 2024 ATMP guidelines revision
·18 weeks remaining insufficient to recover 49-patient deficit without addressing systemic enrollment friction
65%
confidence
3.
Patient eligibility criteria for factor VIII levels excluding borderline candidates leading to 40-55% screen failure rate across underperforming sites
·Phase 3 hemophilia A gene therapy trials historically show 45% mean screen failure when inclusion criteria require <1 IU/dL factor VIII
·Underperforming sites represent smaller hemophilia treatment centers with less severe patient populations
·67% cumulative enrollment suggests protocol-driven constraint rather than execution failure
58%
confidence
Recommended action
Conduct immediate site-specific diagnostic calls with S-1047, S-1112, S-1089 PIs to confirm competing trial/regulatory hypotheses, then evaluate protocol amendment relaxing factor VIII threshold to <2 IU/dL (expected 18-22 additional eligible patients, 85% confidence) or activate 2-3 backup US sites within 4 weeks.
Pre-drafted escalation
Dr. Mehta / Site Leadership Team — Our monitoring indicates Site 47 enrollment significantly below trajectory at 12% of target with 18 weeks to database lock. We're scheduling a 30-minute diagnostic call this week to understand site-specific barriers and explore mitigation strategies. Given CSL824's $2.8B commercial potential and $8.2M monthly cost-of-delay, we're evaluating protocol amendments and backup site activation in parallel. Please share current patient pipeline status, competing trial enrollment, and any regulatory/IRB delays. We're committed to supporting your site's success while protecting study timelines. Our CRA will coordinate scheduling within 48 hours.
Citations
Studies under surveillance
4 active · health-scored hourlyCSL-HEM-021Phase 3Hematology / Gene Therapy
CSL824 — Gene Therapy for Hemophilia A (Phase 3 pivotal)
Enrollment
67%
98/147
Health
68
CSL-IRD-031Phase 3Iron / Nephrology
Ferinject in CKD anemia — head-to-head Phase 3
Enrollment
76%
412/540
Health
64
CSL-HAE-007Phase 4HAE
ANDEMBRY-NextGen — pediatric indication expansion (Phase 4)
Enrollment
78%
187/240
Health
74
CSL-IMM-203Phase 3Immunology
IgPro20 in CIDP — long-term extension
Enrollment
75%
240/320
Health
71
Risk Investigator (Claude Sonnet 4.5) pre-builds case before user acknowledges · audit trail in /audit