Real-World Evidence &
CEBIS supports observational and real-world evidence programs designed to answer clinical questions using information generated across routine practice and broader patient settings.
Our teams can coordinate study operations, data management, biostatistics, safety and medical writing around the objectives of the research program.
Evidence Beyond the
Controlled Trial Setting
This type of research can support questions related to:
- Safety
- Clinical outcomes
- Treatment patterns
- Broader patient populations
- Product use in routine practice
- Long-term follow-up
- Less common events
Research Designed Around
the Evidence Question
Prospective Observational Studies
Collect information going forward from participants or clinical sites according to a defined observational research plan.
Retrospective Research
Review existing clinical information to investigate a defined question using previously generated data where appropriate.
Post-Marketing Observational Studies
Collect information from routine clinical use after a product has reached the market.
Outcomes Research
Evaluate clinical outcomes and other relevant measures within broader patient populations.
Safety-Focused Research
Generate additional information related to product safety and uncommon or longer-term events.
A Structured Approach to
Real-world evidence still requires a clear question, defined data collection and consistent study delivery.
Define the Research Question
Clarify what the sponsor needs to understand and which population or clinical setting is relevant.
Develop the Study Approach
Define the study population, data requirements, participating sites and operational plan.
Collect & Manage the Data
Coordinate participating sites and ensure study information is collected, reviewed and managed consistently.
Analyze & Report
Use biostatistics and medical writing to help interpret and communicate the study findings.
From Real-World Information
to Study Results
Observational research can involve information collected across different patients, sites and clinical settings. A clear data-management and analysis plan helps turn that information into usable study results.
CEBIS can coordinate:
- Data-management planning
- Study database and data collection
- Data review and cleaning
- Reconciliation
- Statistical analysis
- Interpretation
- Study reporting
Part of a Broader Evidence Strategy
Real-world evidence and observational research can form part of a broader Phase IV and post-marketing development strategy.
CEBIS can coordinate these studies alongside clinical operations, safety, data, statistical and medical-writing support.
Have a Real-World Research Question?
Tell us what you need to understand, the target population, available data and where the research may be conducted. CEBIS can discuss an appropriate observational or real-world evidence approach.