Pillar 4 of 6 · Where & How
Where do you run it — and at what cost?
Sites and investigators on a map, ranked by track record and competition, with a budget band that is modelled rather than asserted.
Where do you run it — and at what cost?
What it answers
Where do you run it — and at what cost?
Country selection and site selection are where a feasibility plan becomes an operational one. This pillar turns "we will run it in Europe" into named facilities, named investigators, honest competition counts, and a cost distribution you can defend line by line.
Which sites are already set up for this?
The physical facilities already running trials in your indication, with their coordinates and their registered contacts — candidate sites as markers you can open, not a country-level tally.
Who is free to run it?
The investigators attached to those trials and their trial history, with the competition they are already carrying — because a well-published principal investigator with four active trials is not available capacity.
What will it cost, and how wrong could that be?
A per-patient cost built from named components with uncertainty bands, scaled by country, and simulated into a total-cost distribution with its drivers ranked.
Inside the pillar
6 analyses, each one named and cited
These are the analyses that actually run — not a category list. Each states what it computes and what it needs, because an analysis that quietly degrades is worse than one that reports it could not run.
Study sites & contacts map
Emits one row per physical facility already running a trial in your indication, with its geo-coordinate and the site-level contacts the registry publishes — so a candidate site is a clickable marker with a person to call, not a country count.
Needs
An indication. For a study with no registry entry of its own, the candidates are the sites already set up to run trials like yours.
Site & investigator selection
Assembles the investigators attached to those trials with their trial history, and where a registry lists only placeholder contacts, falls back to the authorship of the trial’s own publications. Same-name investigators are disambiguated rather than merged into one implausible super-investigator.
Needs
Registry records for comparable trials, plus their linked literature. A trial with neither named investigators nor publications yields no investigator rows — not a guessed one.
Site density vs. competition
Aggregates competing trials to city and country density and reports it three ways — all trials, currently recruiting, and recruiting within the relevant phase — because a city with thirteen trials that finished a decade ago is not a city with thirteen competitors.
Needs
The same-indication fan-out across ClinicalTrials.gov and WHO ICTRP. Recruiting status is carried through to the count rather than discarded.
Geographic prioritisation
Scores candidate countries on a composite of disease burden, site availability, competition and regulatory friction, and publishes the weights, bin thresholds and their provenance so the score is reproducible from the row alone. Coverage is stated explicitly — n of m countries scored.
Needs
The indication and a candidate country set. Your own regulatory assessments and prior-trial enrolment override the public priors where you have them. A country with no epidemiology is marked unscored, never binned as avoid — a country must not be recommended against for missing data.
Cost feasibility
Builds per-patient cost from drug, procedures, site management, monitoring and pharmacovigilance components, each a point estimate with a triangular uncertainty band and a country multiplier. A large Monte Carlo turns that into a total-cost distribution with p10 / p50 / p90 and a driver tornado. The simulation seed is derived from the inputs, so a re-run reproduces the same figure.
Needs
An enrolment number and a country mix. Without a real enrolment denominator the total is not published — a per-patient figure multiplied by an invented headcount is not a budget.
Operational benchmarks
Reports how much operational literature exists per benchmark topic — ethics approval, site activation, enrolment rate, coordinator turnover — as real literature hit counts, so you can see where operational evidence is thin before you rely on it.
Needs
The indication. This is literature coverage: it deliberately derives no duration, date or enrolment rate, and renders an explicit "timeline not computed" state rather than a plausible-looking chart with no evidence under it.
Where the evidence comes from
Public sources, named
Cost components are anchored in published fee schedules and country economic indicators, not in a proprietary benchmark database. That makes the band checkable — and it also means it is a public-evidence band, not your contract research organisation’s quote.
ClinicalTrials.gov
U.S. National Library of Medicine · Daily
Registry of public and private clinical studies worldwide — enrollment, status, sponsors, sites, and outcomes.
clinicaltrials.gov (opens in a new tab)AACT
Clinical Trials Transformation Initiative (CTTI) · Daily
Relational, queryable database of all ClinicalTrials.gov content — the analytical backbone for site and enrollment statistics.
aact.ctti-clinicaltrials.org (opens in a new tab)PubMed
NCBI / U.S. National Library of Medicine · Daily
Biomedical literature index of 36M+ citations — used to ground indication baselines and standard-of-care evidence.
pubmed.ncbi.nlm.nih.gov (opens in a new tab)Also read by this pillar
What you get
What lands in the assessment
Every site, contact and competing-trial count links to the registry record it came from; every cost component names the schedule or indicator behind it and the country multiplier applied.
- An interactive site map with per-facility markers, contacts and the trials each site is already running
- A ranked investigator list with trial history and competition load, and the fallback path stated where it was used
- A country prioritisation table with published weights and an explicit coverage statement, plus a cost distribution with p10 / p50 / p90 and a driver tornado
Read by these expert roles
A role drafts from this pillar; a human reviews and signs off. The sign-off is a 21 CFR Part 11 e-signature on a hash-chained record.
How the roles workHonest limits
What this pillar cannot tell you
Every assessment method has a boundary. Publishing ours is the point — a number you cannot check is worth less than a gap you can see.
A cost band is a band.
It is built from public benchmarks and country multipliers. It is a decision-grade range for a go/no-go, not a budget you can sign — your contract research organisation’s quote will differ, and should.
Site contact data goes stale.
Registries are updated when a sponsor updates them. A listed principal investigator may have moved, retired, or closed the unit. Treat the map as a qualified starting list for outreach, not a verified roster.
No timeline is modelled here.
Operational benchmarks report how much literature exists per topic. They do not produce a milestone schedule, and the assessment says "timeline not computed" instead of drawing one that would look authoritative and be invented.
Competition counts are registry-bounded.
A competitor that never registered, or registered in a network outside the fan-out, is not in the density figure. The count is a floor on competition, not a ceiling.
The rest of the assessment
No pillar decides alone
Each pillar answers one question. The Verdict composes all six into a single go/no-go, with the risks that could still change it.
See a verdict you can actually check.
Send us a protocol — or just a molecule and an indication. We'll return a fully cited feasibility assessment you can trace, line by line, back to public data — yours to defend in a bid, take to your board or investment committee, or hand to a regulator.