Global value dossier
GVD development support, from module architecture to a first release, to the agreed scope.
Shortlist it, send it over — we come back with the shape we'd actually recommend.
What global value dossier actually is.
The global value dossier built as a set of reusable modules, disease overview, unmet need, clinical value, economic value, patient value, comparative effectiveness, rather than a single 400-page document affiliates copy-paste from. Scope is agreed up front, from the module architecture and evidence base through to authoring the modules in scope.
Built for global access teams who need a defensible first release and a module library affiliates will actually localise. Timing depends on the evidence base, the number of modules in scope and internal review cycles.
- The agreed GVD modules as a library with named owners per module
- Module library affiliates pull from rather than re-author
- Evidence anchor per claim with citation and certainty
- Localisation guidance: what affiliates may adapt, what stays locked
- Handover session and operating cadence for the next refresh
Add the pieces you'd want and we'll build a shortlist you can review, reorder and send over. No pricing wall, no commitment — we come back with what we'd actually recommend, including anything you don't need.
Approach, modules, delivery.
Move through the tabs to see how the work runs, what it's made of and what lands at the end.
Inputs
- Clinical evidence base (pivotal + supporting studies)
- Comparator landscape and pricing context
- Country-affiliate value story drafts and HTA precedent
Method
Modular GVD with a tight scientific core, an access-narrative middle layer and country annex slots designed for affiliates to localise quickly. Evidence is tiered (GRADE) and each claim cross-references its source. The GVD is delivered with a maintenance protocol so it actually stays useful past launch.
Assumptions
- Affiliates have authority to add country-specific evidence and pricing into annexes.
- Evidence base is stable enough to support a 12-month refresh cycle.
Limitations
- A GVD does not replace bespoke submissions, it accelerates them.
- Some markets (notably US payer) need a fundamentally different framing than the EU-centric GVD shape.
Think this belongs in your scope?
Add it alongside anything else that fits, then send the shortlist over. We'll reply with the shape we'd recommend — sequence included, and the parts we think you can skip.
Build what comes next.
Whether you need growth, answers or capability, VISFO helps you move earlier and faster.