Build the right evidence, at the right time, to prove value and drive market success.
Table of Contents
Chapter 1. HEOR / RWE Evidence Generation Fundamentals
1.1 What HEOR and RWE Must Prove
1.2 Evidence Needs Across the Product Lifecycle
1.3 Stakeholder Questions: Payers, Providers, Patients, Regulators
1.4 Common Evidence Generation Failure Modes
1.5 HEOR / RWE Readiness Diagnostic
Chapter 2. Value Story, Evidence Strategy, and Governance
2.1 Building the Product Value Story
2.2 Translating Value Drivers Into Evidence Questions
2.3 Evidence Governance, Roles, and Decision Rights
2.4 Cross-Functional Alignment With Medical, Market Access, and Clinical
2.5 Evidence Strategy Checklist
Chapter 3. Evidence Roadmap and Study Portfolio Planning
3.1 Building the HEOR / RWE Evidence Roadmap
3.2 Prioritizing Evidence Gaps and Business Decisions
3.3 Sequencing Studies Across Launch and Lifecycle Milestones
3.4 Budgeting, Resourcing, and Timeline Planning
3.5 Evidence Roadmap Template
Chapter 4. Study Design, Endpoints, and Analytical Approach
4.1 Defining the Research Question and Study Objective
4.2 Selecting Clinical, Economic, Humanistic, and Access Endpoints
4.3 Choosing the Right Study Design
4.4 Managing Bias, Confounding, and Data Limitations
4.5 Study Concept Sheet Template
Chapter 5. Data Sources, Feasibility, and Real-World Data Quality
5.1 Mapping Potential Real-World Data Sources
5.2 Claims, EHR, Registry, Specialty Pharmacy, and Lab Data
5.3 Data Feasibility, Completeness, and Fitness for Purpose
5.4 Vendor, Data Partner, and Platform Selection
5.5 Data Source Assessment Checklist
Chapter 6. Evidence Execution, Quality, and Interpretation
6.1 Protocol Development and Study Start-Up
6.2 Statistical Analysis Plan and Quality Controls
6.3 Study Execution, Monitoring, and Issue Management
6.4 Interpreting Results for Scientific and Commercial Use
6.5 Evidence Quality Review Checklist
Chapter 7. Publications, Payer-Ready Outputs, and Evidence Communication
7.1 Building the Publication and Congress Plan
7.2 Developing Manuscripts, Abstracts, Posters, and Presentations
7.3 Creating Payer-Ready Evidence Outputs
7.4 Translating Evidence Into Value Dossiers and Field Tools
7.5 Evidence Communication Review Checklist
Chapter 8. Implementation Roadmap and External Support Options
8.1 Building the HEOR / RWE Implementation Roadmap
8.2 Internal Capabilities, Operating Model, and Change Management
8.3 Support From Large Consulting Firms
8.4 Specialist HEOR, RWE, Data, and Publication Advisors
8.5 Independent Management Consultants Through Umbrex
