Review queue
The agent pipeline escalates to you only on exception — automated work stops here until you decide. Decisions apply immediately.
Auto-drafted protocol v0.1-auto for study "GAL-001: Adaptive Phase II in Refractory Melanoma" needs medical review. Predicted amendment risk: 0.81 — 6 SPIRIT checklist item(s) unresolved (items missing at v1.0 drive avoidable amendments): trial registration (SPIRIT 2); study design (SPIRIT 8); outcomes (SPIRIT 12); sample size with assumptions (SPIRIT 14); interim analyses and stopping rules (SPIRIT 21b / OCTAVE); harms plan: AE collection, coding dictionary, safety population, harm stopping criteria (SPIRIT 22 / Phillips 2019).
Feasibility score 0.45 for "GAL-001: Adaptive Phase II in Refractory Melanoma" (US) is below threshold. Confirm or revise the study footprint.
Feasibility score 0.0 for "GAL-001: Adaptive Phase II in Refractory Melanoma" (EU) is below threshold. Confirm or revise the study footprint.
Auto-compiled IND amendment for GAL-001 is ready. Regulatory affairs must approve before submission to FDA.
Data query on field "conmed_dose" could not be auto-resolved: Reported dose conflicts with pharmacy dispensing log; clinical interpretation needed (cross-check against deviation pattern "Subject receive
Serious/severe adverse event requires safety physician assessment: Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-11-11 (study day 469); relationship: not assessed; serious criteria: hospitali
Milestone payment of 23,500 USD to Mount Halifax Oncology Center is due. Finance must approve release.
Auto-drafted CSR for "GAL-001: Adaptive Phase II in Refractory Melanoma" needs medical writing review.
Participant Jonah Reyes has reported feeling 2/5 then 2/5 in consecutive Luna check-ins. Proactive site outreach proposed.
Participant Jonah Reyes voiced withdrawal intent to Luna. Site coordinator outreach requested — participation is voluntary; only support, never pressure.
Matching engine (partner:ehr-rwd-matching) found 14 candidate patients for "GAL-001: Adaptive Phase II in Refractory Melanoma". Approve import for screening — matching never auto-enrolls.
3 patient(s) at elevated dropout risk: GAL001-001 (0.78), GAL001-002 (0.78), GAL001-004 (0.8). Approve proactive outreach before disengagement.
3 early-termination risk flag(s) on "GAL-001: Adaptive Phase II in Refractory Melanoma": Accrual pace 11% of the pro-rata plan (4 accrued vs ~36 expected; heuristic threshold 60% — poor accrual causes 34.5% of early terminations) · Phase II (elevated early-termination odds, OR 1.6–2.4) · Serious-AE density 33% (1 serious AEs / 3 enrolled)
2 auto-generated TLF outputs for "GAL-001: Adaptive Phase II in Refractory Melanoma" await double-programming-equivalent validation.
2 auto-generated TLF outputs for "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimers Disease." await double-programming-equivalent validation.
Auto-drafted CSR for "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimers Disease." needs medical writing review.
2 auto-generated TLF outputs for "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" await double-programming-equivalent validation.
Auto-drafted CSR for "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" needs medical writing review.
Site "SITE009 (AUS)" KRI score is 0.84 (14 serious AEs across 30 patients, 7 open QA findings, 0 aged data queries). An on-site visit is proposed for 2026-09-01.
Site "SITE015 (POL)" KRI score is 0.77 (17 serious AEs across 30 patients, 6 open QA findings, 0 aged data queries). An on-site visit is proposed for 2026-09-01.