Clinical Development
Can our protocol recruit, and where do the eligible patients actually live?
Know what others can’t by connecting real-world patient, clinical and site signals to test feasibility before assumptions become protocol decisions.
Regulators and payers now expect more real-world context than a trial can produce on its own. The RWE foundation your team builds during development is what carries your label and every payer conversation that follows.
Our ecosystem provides the connected patient data those artifacts require, ready when reviewers ask for it rather than reconstructed after the fact.
A protocol can look feasible on paper and still struggle to recruit patients. Inclusion criteria, biomarkers and prior treatment shift who qualifies and where they live. Real-world data can surface that risk before the protocol is finalized.
The same evidence supports every phase: dose selection in Phase 1, cohort and biomarker validation in Phase 2, feasibility modeling and external comparators in Phase 3, and natural history plus site-selection intelligence through submission. When it sits on the connected data ecosystem your launch teams will still be running years later, cohorts and comparators carry forward without a rebuild.
Can our protocol recruit, and where do the eligible patients actually live?
What does the natural history look like without our intervention?
What outcomes will regulators and payers expect us to have addressed at filing?
How large is the real population, and how much variability should we plan for?
Which sites and investigators are already treating this patient?
Diagnosis codes and historical site performance can indicate where a population may exist. They don’t necessarily show how many patients meet the full protocol criteria, which criteria will drive screen failure, or whether the sites traditionally used for trials are where those eligible patients are actually receiving care.
At this stage, your team can start with an eligible-patient count built against the inclusion criteria you actually plan to use, drawn from the most comprehensive view of U.S. patients on the market. From there, a natural history cohort follows those same patients across care settings and payer changes, ready to serve as an external comparator that stands up to ICH M14 expectations. Sites get chosen based on where your target patients actually receive care today, not where investigators have run trials before.
And because all of it lives on the same connected patient data your launch teams will still be running years later, your team defines the cohort once. That definition still holds at launch, without rewriting the criteria for a new dataset.
Bring us your clinical development question and we’ll help identify the patient, clinical and site signals needed to pressure-test feasibility before protocol lock.