Global-to-Local HTA Dossier Adaptation

The Challenge

A global pharma organization needed to create localized value dossiers across six markets simultaneously. The evidence already existed, but delivering it to affiliate teams consistently, efficiently, and with full traceability was a major challenge.

Key Challenges Included:

Duplicated Effort Across Every Market
Affiliate teams rewrote the same clinical claims six times, with no shared source of truth or inheritance from the global value dossier.
No Visibility Into Global Value Dossier (GVD) Changes Mid-Cycle
When the global dossier was updated, affiliate teams had no way of knowing. As a result, local teams often worked with outdated content until the gap was identified during review.
Fragmented Review Process with No Audit Trail
Approvals were managed through email exchanges across Word documents and SharePoint. There was no section ownership, comment tracking, version control, or centralized review workflow.
Submission Readiness Unknown Until It Was Too Late

Progress and readiness status were tracked manually using spreadsheets, often leaving teams with limited visibility until just weeks before submission deadlines.

Our Solution

A Governed Global-to-Local Localization Workspace

Governed Evidence Foundation

Evidence structured once at global level, linked to claims, and reused across all local workspaces with freshness and version tracking.

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Controlled Inheritance with Local Overlays

Country workspaces inherited global content directly. Affiliates applied structured local overlays for comparators, epidemiology, and payer framing — without starting from blank documents.

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Agency-Specific Scoping and Mapping

PICO scope captured at initiation. Evidence blocks automatically mapped to sections required by each HTA agency — NICE, G-BA, HAS, AIFA, and JCA.

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Structured Review by Section and Market

Reviewer assignment, comment threads, and approvals tracked by section, country, and role. No review lost in email.‍

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Real-Time Readiness Dashboard

Missing evidence, unresolved comments, and localization status visible per market — continuously, not on deadline day.

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Key Impact

~60% Reduction in Affiliate Rework

vs. copy-paste-from-Word baseline (Illustrative — to be validated against client baseline)

6 Markets Managed in Parallel

From a single version-controlled GVD source

The Customer

A large-cap global pharmaceutical organization managing simultaneous HTA submissions across oncology and specialty portfolios. End users include Global Market Access Directors, Regional Affiliate Leads, HTA Strategy teams, and Submission Readiness leads.