Claim Enhancement

The Idea

Baseline → Target Claim

Baseline → Target Claim

Baseline → Target Claim

We quantify the upgrade (e.g., from “helps to relieve” to “significantly reduces”).

Efficacy Delta (Δ)

Baseline → Target Claim

Baseline → Target Claim

We translate that upgrade into a minimum effect that must be shown (vs. placebo or usual use) to justify the stronger wording.

Proportionate Design

Baseline → Target Claim

Proportionate Design

Trial design, endpoints, sample size, and oversight are right-sized to detect Δ with high confidence—nothing more.

How We Do It

Claim Map & Δ Definition

Pin the exact words you can claim today and the target claim text.
Define the minimum clinically important difference (MCID) or margin that separates today’s evidence from the target.

Endpoint & Model Selection

Choose validated, label-relevant endpoints (e.g., PROs, functional scores, simple biomarkers).
Decide comparator: placebo, add-on to usual care, or self-controlled (crossover/n-of-1) when appropriate.

Right-Sized Statistics

Power the study precisely to Δ: smaller Δ ⇒ larger N; larger Δ ⇒ smaller N.
Prefer crossover or within-subject designs to cut sample size when the condition is stable and carries over.
Use superiority for “reduces/improves” upgrades; noninferiority for equivalence-style claims (when pivoting formats).

Lean Operations for Minimal-Risk Products

Decentralized elements (eConsent/ePRO), short follow-up, simple visit schedules.
Risk-based monitoring and proportionate TMF/eTMF.
Single-country, ≤3 sites if feasible.

Regulatory Alignment

Build the protocol and SAP to match NNHPD expectations and advertising standards.
Pre-wire the evidence narrative you’ll need in the PLA amendment or promotional substantiation file.

Analysis & Wording Control

Pre-specify the estimand and minimal difference to avoid over-claiming.
Keep secondary endpoints supportive, not inflationary; include a claims wording table tied to outcomes.