Cartis

Label Forecast Intelligence

Model the label an asset could realistically earn before pivotal design is locked, with aspirational, base, and minimal-competitive scenarios built from regulatory precedent, society guidance, and competitor filings.

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Cartis is Oncofocus's label scenario intelligence platform — a structured evidence engine that models the label an asset could realistically earn across three scenarios before pivotal design is locked. Built for clinical strategy, regulatory affairs, and commercial teams who need to design trials around the label they want to win, not the one they end up with.

What Cartis Does?

PLATFORM CAPABILITIES

The label your asset could earn with best-in-class execution and a favourable regulatory climate — built from the most expansive precedent approvals in the class. Anchored to what has been granted, not just what has been requested.

Aspirational Scenario

The most probable label outcome based on current evidence, typical agency precedent, and the competitive field. This is the scenario that drives primary TPP and trial design — the one your pivotal study should be built to deliver.

Base Case Scenario

Minimal-Competitive Scenario

The narrowest defensible label if the competitive bar is high or the evidence falls short. Stress-tests your commercial viability at the floor and identifies the minimum claim required for a viable launch.

Regulatory & Society Evidence Base

Every scenario grounded in FDA, EMA, and PMDA guidance documents alongside NCCN, ASCO, ESMO, ACR, and EULAR recommendations — the exact sources regulators and payers consult when assessing indication scope.

Competitor Label Gap Analysis

Gap analysis of label requested versus granted across close competitors and prior approvals — indication breadth, biomarker scope, line-of-therapy claims, and combination language mapped against what was actually approved.

TPP & Trial Design Implications

Each scenario translated into concrete trial design, endpoint selection, and target product profile implications — delivered before your pivotal study brief is finalised so design choices are anchored to realistic label outcomes.

Designed For These Roles

VP Clinical Development

Who Uses CARTIS

Head of Regulatory Strategy

VP Portfolio Strategy

Director Competitive Intelligence