AMNOG dossier
Module 4, ready for G-BA, in nine days.
Knowledgeable maps your competing treatment, drafts the clinical benefit narrative against G-BA's expectations and traces every claim back to the trial publication, label or SmPC. Your senior reviewer opens a document that is already at QC, not at first draft.
Watch it run on your work.
Where this fits in your workflow.
Knowledgeable maps your competing treatment, drafts the clinical benefit narrative against G-BA's expectations and traces every claim back to the trial publication, label or SmPC. Your senior reviewer opens a document that is already at QC, not at first draft.
Most teams running AMNOG today juggle a stack of search tools, PDF readers and consultancy slides, then spend the back half of the project reconciling claims to sources. Knowledgeable collapses that into one defensible workflow: module 4, ready for g-ba, in nine days.
The work runs against your literature, trial registries, HTA precedent, label and SmPC, with every sentence pinpoint-cited so your senior reviewer opens a document that's already at QC.
- 1Scope & competing treatment locked
- 2Evidence pulled & graded
- 3Draft built with citations
- 4QC pass against framework
The work that finally lands the way you scoped it.
Reviewer-shaped, not template-shaped
Sections, competing treatments and appendices land where the G-BA assessor actually looks. No reformat sprint the night before submission.
Every claim sourced
Pinpoint citation to publication, SmPC or label on every sentence. Your QA lead audits in an afternoon, not a fortnight.
Competing treatment pre-mapped
G-BA competing treatment logic pre-applied across the indication tree so the dossier does not get bounced on a definition.
Pre-built rebuttals
Anticipated objections and a rebuttal pack grounded in published precedent, ready before the IQWiG report lands.
Bring your next AMNOG into one system.
Pressure-test your next AMNOGPre-answered for G-BA, IQWiG, medical and legal review, and InfoSec.
EU AI Act mapping, DPA, sub-processor list, SSO with 2FA, audit log, EU residency. Packaged the way your DPO and InfoSec want to see them.