Lumina RWE Service Process
Where smart choices meet outstanding results
Initial Engagement/Discovery
- Introductory outreach or referral
- High-level overview of client needs and Lumina RWE capabilities
- Explore client objectives, challenges, and timelines
- Identify therapeutic areas, regulatory priorities, and payer considerations
Due Diligence & Assessment for Proposal & Scope Definition
- Review available data sources and gaps
- Assess regulatory and payer landscapes
- Align on feasibility and potential approaches
- Develop tailored study or service proposal
- Define deliverables, timelines, and cost structure
- Ensure alignment with client expectations
Contracting & Onboarding
- Execute agreements (MSA, SOW)
- Assign project team and establish governance framework
Study Initiation ; [Study Design & Data Acquisition]
- Design real-world evidence study protocols or service framework
- Confirm alignment with scientific standards, regulatory guidance, and payer needs
- Identify and source real-world data (claims, EMRs, registries, patient-reported outcomes)
- Establish data management and quality controls
Analysis
- Conduct analyses using validated methodologies
- Monitor safety, effectiveness, and outcomes
- Engage with client on interim updates
Deliverables & Submissions
- Prepare regulatory-ready reports, HEOR evidence packages, and payer dossiers
- Tailor deliverables to audience (regulators, payers, clinicians)
- Clinical/Journal Publication
Strategic Advisory & Support
- Guide client through regulatory interactions, payer discussions, or scientific communications
- Support publications, conference presentations, and stakeholder engagement
Post-Project Partnership
- Monitor long-term outcomes and evolving evidence needs
- Identify opportunities for follow-up studies or lifecycle support