GalenOps prod · 0.1.0

Runs

3

Escalations

0

Failures

0

Avg duration

4.4 s

Literature & benchmarks

  • Martinez et al. 2016 (Trials 17:106) — 78 industry trials: contract negotiation median 33 d / Q3 77 d, budget 40 / 68 d, IRB approval 3–4 d; contract and budget, not IRB, are the critical path
  • Kurbegov et al. 2021 (ASCO Research Statement) — a feasibility assessment on file is a prerequisite for activation

Run history (3 across all studies)

Newest first, 50 per page. Expand a row for the recorded reasoning and evidence.

Expand When Study Outcome Model Duration Reasoning
2026-09-29 23:42 UTC A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma completed claude-sonnet-5 4.5 s This study is complete, with all 34 sites activated and contracts executed. Contract days of 55 sit between the benchmark median of 33 d and Q3 of 77 d (Martinez et al. 2016, Trials 17:106), so none breach the negotiation thresholds. Days-to-FPI of 21 for the 30 sites with dates is well under the 60 d slow-FPI cut-off (Dombernowsky et al. 2019, Trials 20:708) and the 90 d non-enrolling threshold, consistent with the summary's "0 slow FPI, 0 non-enrolling." However, 0/34 sites are marked activation-ready because every site is missing "no regulatory submission on file for the study," per the deterministic summary. No document-chase tasks were opened. A human should decide whether the missing regulatory submission needs to be obtained or reconciled despite the study's completed status.
2026-09-29 21:13 UTC A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer completed claude-sonnet-5 4.2 s All 15 sites are activated with contracts executed and readiness scored 1.0 each, with feasibility and regulatory submission both on file. Every site shows contract_days of 55, which is below both the contract negotiation median of 33 d... actually above the median (33 d) but under the Q3 of 77 d per the Martinez et al. 2016, Trials 17:106 benchmark; 0 sites show over_median or q3_breach. Days_to_fpi is 21 for all sites, well under the slow_fpi threshold of 60 d (Dombernowsky et al. 2019, Trials 20:708 heuristic). No site is non-enrolling past the 90 d threshold. The deterministic summary confirms: 15/15 sites activation-ready, 0 in negotiation, 0 slow FPI, 0 non-enrolling, and no document-chase tasks were opened (tasks_opened: 0). No human decision is required at this time.
2026-09-19 08:58 UTC A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer completed claude-sonnet-5 4.4 s All 15 sites are activation-ready with contracts executed (contract_days 55 each, versus benchmark contract negotiation median 33 d, Q3 77 d) and readiness scored 1.0 for every site. Days to FPI is 21 for all sites, well under the slow_fpi threshold of 60 days and the non_enrolling threshold of 90 days (Dombernowsky et al. 2019, Trials 20:708; Martinez et al. 2016, Trials 17:106). The deterministic summary confirms 0 sites in negotiation, 0 over the 33 d median, 0 past the 77 d Q3, 0 slow FPI, and 0 non-enrolling activations. Feasibility and regulatory submission documentation are on file for the study. No missing items are listed for any site, and tasks_opened is 0, so no document-chase task was created. No human decision is required at this time since no review task was opened.