There’s no one-size-fits-all approach to PASS feasibility — and most frameworks miss the market context that actually determines whether a data source will work.

Reimbursement pathways, healthcare system structures, and data granularity shift country by country, yet many feasibility approaches apply the same checklist everywhere and hope it holds. Our new whitepaper shows how we build context into every step, so sponsors know before submission, not after, whether a source will hold up in the specific country where it needs to.

Highlights include:

• A 3-step framework, applied with judgment: Quantitative testing is reserved only for sources already worth the investment
• Bespoke by market, not by template: In a real case study across Brazil, EU, and UK, the same core methodology flexed to each market’s constraints
• Right-sized to timing and risk: Starting early means findings can shape the protocol, not just validate a design already decided upon
• A cost calculus, not a checkbox: Weighed against a program spanning multiple years and significant investment, that upfront step is what determines whether the rest of the investment is protected or put at risk

Lumanity doesn’t just assess whether a data source is good, we assess whether it’s right for that market, that reimbursement landscape, and that regulator.

Read the full paper for the framework, case study, and five field-tested advantages.