Plan the Proof, Accelerate Access with Integrated Evidence Planning
Our integrated evidence planning model aligns regulatory, clinical, economic, and real‑world studies from day one, reducing approval‑to‑coverage lag ≈ 12 months
Why an Integrated Evidence Plan – Right Now?
Global regulators embrace real-world evidence (RWE), EU MDR mandates post‑market data, and investors won’t fund launches without a clear reimbursement story. Siloed trials waste cash and time; an Integrated Evidence Plan (IEP) synchronizes every data stream, so each study serves multiple stakeholders and not just the next milestone.
What an IEP Delivers
A living, cross‑functional roadmap that:
- Maps evidence gaps across FDA/CE, HTA, payers, clinicians, and patients.
- Scores each proposed study via an Evidence‑Impact Score (lift vs. cost).
- Outputs a claims matrix, study designs, timelines, and ROI dashboard—updated every 12‑18

Our 3 Phase Integrated Evidence Plan Framework
*Typical 12–18-week timeline; multi region projects scale accordingly.
Phase | Spring Focus | Outputs & Timing* |
---|---|---|
01Kick Off & Info Exchange |
Form core team; ingest business goals, existing data. |
Updated claims matrix + draft gaps list (Week 0 5+2). |
02Landscape & Gap Workshop |
Lit review, competitor mapping, payer/reg case studies; consensus workshop. |
Gap analysis deck + prioritized evidence list (Week 6 9+2). |
03Draft → Workshop → Final IEP |
Build 3 5 yr roadmap, budgets, success metrics; validate in second workshop. |
Excel IEP + PPT roadmap; hand off plan (Week 10 12+2). |
IEP Service Modules
From Gap to Roadmap
Even the strongest integrated evidence planning effort fails if it stops at a slide deck. That’s why we convert the roadmap into four executable work‑streams—each built to answer a specific regulatory, clinical, or payer question while reinforcing the others. Together they form a closed loop: identify the gap, design multi‑purpose studies, pressure‑test endpoints with real stakeholders, then track ROI as data roll in. Flip the cards below to see how each module moves your device or assay one step closer to reimbursed reality.

Evidence Landscape & Gap Analysis
Evidence Landscape & Gap Analysis
What we do: Focused review of guidelines, predicates, ongoing trials.
Your Advantage: See exactly which data still matter—and which don’t.

Study Sequencing & Multi Purpose Protocols
Study Sequencing & Multi Purpose Protocols
What we do: Design trials that satisfy regulators, payers, and clinicians in one shot.
Your Advantage: Increase study‑cost savings via synergy.

Stakeholder Validation Workshops
Stakeholder Validation Workshops
What we do: Live sessions with payers, regulators, KOLs.
Your Advantage: De‑risk endpoints before you lock protocols.

Living Evidence Dashboard & ROI Tracker
Living Evidence Dashboard & ROI Tracker
What we do: Track milestones, spend and impact.
Your Advantage: Course‑correct fast and prove ROI to executives.
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Integrated Evidence Plan – Frequently Asked Questions
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What’s the purpose of an Integrated Evidence Plan (IEP)?
To create a single, cross‑functional roadmap that tells you which studies to run, in what order, for which stakeholders—so every dollar of evidence spend moves you closer to regulatory clearance and payer reimbursement.
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What’s the main benefit of having an IEP?
It cuts approval‑to‑coverage lag by ≈ 12 months and avoids duplicate studies by designing multi‑purpose protocols—often saving up to 30 % in study costs while accelerating revenue and patient access.
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When is the best time to start an IEP?
Earlier is ideal (concept or feasibility), but it’s never “too late.” Even mid‑development, an IEP can realign ongoing trials, prioritize the remaining evidence gaps, and prevent costly post‑market surprises.
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What do receive from an IEP engagement?
- A living Excel + PPT roadmap covering 3–5 years of studies, timelines, and budgets.
- An Evidence‑Impact Scorecard that ranks each study’s ROI.
- A claims matrix mapping data to regulatory, clinical, and payer requirements.
- A dashboard to track milestones, spend, and ROI as data accrue.
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Cut approval-to-coverage lag and save on study spend by partnering with the Innovation CRO for a data-driven roadmap.



