Enterprise
pharma.
For sponsors running parallel programs across therapeutic areas. Where every program inherits what the last one learned.
// Where the work breaks
Three problems
Three problems
at portfolio scale.
Enterprise sponsors run more clinical programs in parallel than any other operator. Every design passes through every function before submission: clinical, biostats, regulatory, medical affairs, pharmacovigilance. The pains below repeat across teams and across therapeutic areas.
P / 01
Design decisions don't compound.
Endpoints, eligibility, sample sizing, regulatory positioning; each program rebuilds them, and the rework shows up as amendments after first patient.
~$5M Avg. design-driven amendment cost per Phase 3 · Tufts CSDD
P / 02
Every function sees the design differently.
Clinical, biostats, regulatory, medical affairs, pharmacovigilance; all carry assumptions into the design, and drift between them surfaces late in the review cycle.
5+ Functions shaping every trial design before submission
P / 03
The regulatory bar moves under the design.
FDA, EMA, PMDA, and NMPA each ship guidance updates throughout the year; the ones that touch your design tend to surface after positioning is already fixed.
~40 Guidance updates · 2025 · across FDA, EMA, PMDA, NMPA
// What changes
We change that, by stress-testing the design against the corpus and the regulator before the protocol is drafted. By bringing all teams early on the design, before assumptions harden into amendments. And by inheriting what prior trials learned in your own Knowledge Hub, alongside the systems you already run, never in a shared training set.
// Target outcomes
What a twelve-month deployment is sized to deliver.
Sized against an enterprise sponsor running parallel programs across multiple therapeutic areas. Baselines are program-specific. The pattern holds at portfolio scale.
42%
Reduction in design-driven amendments per trial
Across 14 programs · vs. prior 24-month baseline
3.5 mo
Cycle time from synopsis to final protocol
Median across Phase 2/3 · vs. internal SLA
$31M
Avoided amendment cost · annualized
Estimate · prior amendment economics × deflection rate
+18 wks
Time-to-first-patient, ahead of plan
Pooled across Phase 2/3 starts · vs. unit baseline