Operations dashboard
One review dashboard per study — decisions arrive grouped under the study and therapy they concern, never as one flooded queue. Open an item's details before deciding.
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.
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.
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.
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.
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.