site feasibility / clinical ops / venture prototype
Leadership-style internal SaaS demo for country/site prioritization, scenario simulation, and explainable recommendations.
Study Design and Protocol Burden Workspace
Frame how protocol features drive downstream feasibility. This is the surface used to explain why good sites still fail when the design is too heavy.
RESP-204 design profile
Study
RESP-204
Phase II · ILD
Operational target
180 patients
Initial country package across EU6
Inclusion / exclusion burden
82/100
Likely to elevate screen failure if referral quality is weak
Procedure load
74/100
Imaging cadence and pulmonary tests challenge low-capacity sites
Protocol complexity lens
Screening load
ILD phenotype confirmation plus imaging review means community sites with weak pre-screening pathways are structurally disadvantaged.
Visit cadence
Week 0/4/8/12/16/24 imaging rhythm favors sites with protected imaging slots and stable coordinator staffing.
Country gating implication
Fast-start countries help FPI optics, but the protocol still requires a few academically dense sites to hit total enrollment.
Leadership takeaway
The shortlist is not just the highest-scoring sites. It is the smallest cross-country mix that can absorb protocol complexity, hit activation optics, and still protect enrollment.