// The platform
Let your data guide your decisions
Let your data guide your decisions
and your expertise call the shots.
ACT 01. CONTEXT
Start anywhere.
Start anywhere.
Stay in your stack.
ACT 02. ACTION
Optimize your design.
Optimize your design.
Across dimensions.
Optimization
·
candidate Phase 2
▸
starting
audit —
parameters —
APPLY CHANGES
ACT 03. SIMULATION
See the trial
See the trial
before it runs.
Simulation
·
candidate Phase 2
›
simulatebaseline
⟁fitting recruitment model from 14 priors
⟁cross-referencing SUSTAIN-1, PIONEER-3, AWARD-7
✓10,000 trajectories · P(success) 84.0%
✓DB lock · week 52
›
addinterimfutility@ wk 26cp < 0.20
⟁computing operating characteristics under H1
✓early-stop probability 12% at IA1
⚠power 84% → 82% (−2 pp)
✓DB lock 52 → 48 wks · cost −$800k
›
re-estimateNatIA1
⟁solving for N under observed variance (cap +12.5%)
✓N 320 → 360 · power +7 pp
⚠+6 weeks · cost +$1.4M
›
enrichHbA1c≥8.5%
⟁resampling within enriched stratum (n_screen ×2.4)
✓N 320 → 240 (enriched stratum)
⚠label restricted to enriched subgroup
✓−6 wks · −$1.2M · power +4 pp
↑recall
tabcomplete
⌘kclear
// live preview
active
scenario 01 · baseline
scenario 02 · interim futility
scenario 03 · adaptive N
scenario 04 · enrichment
baseline · no change
−4w · −$800k · −2pp
+6w · +$1.4M · +7pp
−6w · −$1.2M · +4pp
APPLY SCENARIO
ACT 04. ASSEMBLY
Bring it all together.
Bring it all together.
Keep everyone in sync.
Draft
·
§2.1 · 3 collaborators
active · room open
// section 2.1 · study objectives
v2.3 · drafting
Primary endpoint
Primary. To evaluate the efficacy of semaglutide 1.0 mg once-weekly versus placebo (matching placebo subcutaneous injection)[3] in reducing HbA1c from baseline to Week 52 in adults with type 2 diabetes inadequately controlled on stable metformin (≥ 1500 mg/day).
Secondary. To evaluate change in body weight, fasting plasma glucose, and the proportion of subjects achieving HbA1c < 7.0% at Week 52, consistent with the ADA 2026 general glycaemic target.[7]
Exploratory. To explore associations between baseline HbA1c, BMI, and treatment response; to characterise PK–PD relationships in a subpopulation of N≈120 across two academic centres.
7 / 10 sections drafted
2 open comments
11 diffs accepted
21 citations linked