RWD/RWE Studies
Full-service RWE support from protocol synopsis to final publication — AI-enhanced EDC setup, observational study design, data collection, analysis, and reporting.
What you get
Protocol synopsis
Study design document with objectives, methodology, and endpoints
Ethics submission package
Complete documentation for ethics committee and regulatory approval
EDC system setup
AI-enhanced electronic data capture configured for the study
End-to-end RWE delivery
From protocol design and ethics submission through data collection, analysis, and publication — not just one phase of the study.
AI-enhanced data capture
AI tools accelerate EDC setup, data extraction from unstructured sources, and quality monitoring during collection.
Publication-grade output
Every study is designed to produce publishable results — with pre-specified methodology and regulatory-compliant documentation.
About this service
Real-world evidence from design to publication
Real-world evidence is increasingly critical for HTA submissions, label extensions, and clinical positioning. But most RWE projects stall between protocol design, ethics approval, and data collection — or produce results that aren’t publishable.
We manage the full RWE lifecycle: study design, ethics submission, EDC setup, site coordination, data collection, statistical analysis, and manuscript preparation. AI-enhanced tools accelerate data capture and quality monitoring — while experienced researchers ensure methodological rigor and regulatory compliance.
Every study is designed to produce results that can be published and used in HTA submissions.
Deliverables
What you get
Protocol synopsis
Study design document with objectives, methodology, and endpoints
Ethics submission package
Complete documentation for ethics committee and regulatory approval
EDC system setup
AI-enhanced electronic data capture configured for the study
Statistical analysis
Pre-specified analysis with publication-ready tables and figures
Study report
Full study report following STROBE or relevant reporting guidelines
Publication manuscript
Peer-reviewed manuscript ready for journal submission
How we work
Five phases to published RWE
01
Design study
Protocol development, endpoint selection, and methodology specification.
02
Ethics & setup
Ethics submission, EDC configuration, and site preparation.
03
Data collection
Site coordination, data capture, and quality monitoring.
04
Analyze & report
Statistical analysis, results interpretation, and study report.
05
Publish
Manuscript preparation, journal submission, and reviewer response.
AI-enabled workflow
AI-enhanced data capture, expert-led research
AI accelerates EDC setup, data extraction, and quality monitoring. Experienced researchers design studies, manage sites, and ensure publication-grade output.
What AI does
- AI-enhanced EDC system configuration and testing
- Automated data quality monitoring and anomaly detection
- Unstructured data extraction from medical records
- Pattern detection and preliminary data exploration
What MAG experts do
- Study design and protocol development
- Ethics submission and regulatory navigation
- Site coordination and investigator management
- Statistical analysis and publication writing
Evidence Scanner™ modules used
AI-Enhanced EDC
Fact-Checker
PubMed/Web Monitoring
Proof
How this service works in practice
AI-powered EHR data mining: identifying difficult-to-treat RA patients from unstructured records
Result:Patient identification approach validated and deployed
Rheumatology
Read case →
National epidemiological study: from protocol design to multi-country publication
Result:Replicated in 2 countries, published in peer-reviewed journal
Rare Disease
Read case →
Orphan drug patient journey: identifying undiagnosed patients in fragmented systems
Result:Patient-finding algorithm deployed in clinical practice
Rare Disease
Read case →
Solves these challenges
Related problems
RWE has been collected but never published
Data exists in registries and medical records, but no study design or analysis plan to make it usable.
See how we solve it →
Need real-world evidence to support a positioning claim
Clinical trial data alone doesn’t answer the payer question — RWE is needed.
See how we solve it →
Data quality concerns in existing real-world datasets
Unstructured EHR data needs extraction, cleaning, and validation before it can support any claim.
See how we solve it →
Frequently asked
Common questions
What types of RWE studies do you support?
Observational studies, chart reviews, registry analyses, patient journey mapping, and database studies using EHR, claims, or registry data.
Do you handle ethics submissions?
Yes. We prepare complete ethics submission packages and manage the approval process for all study sites.
What is AI-enhanced EDC?
Our AI tools accelerate electronic data capture setup, automate data quality checks during collection, and extract structured data from unstructured medical records.
Can you support multi-country studies?
Yes. We coordinate multi-site, multi-country RWE studies with centralized project management and local site coordination.
How do you ensure publication quality?
Every study follows STROBE or relevant reporting guidelines, with pre-specified statistical analysis plans and publication-grade documentation from the start.
Planning an RWE study?
Share your research question. We’ll propose a study design and realistic timeline.
Book a scoping call →
Browse all services
Need real-world evidence?
Tell us your research question. We’ll design the study and deliver publishable results.
AI infrastructure
AI-powered.
Expert-validated.
We built AI workflows into our daily practice — not as a marketing claim, but as the infrastructure that lets our medical experts deliver faster without cutting corners.
Research
Structured PubMed queries with narrative or table outputs
Monitoring
Weekly literature digests by drug, target, or topic
AI-Enhanced EDC
Electronic data capture with AI-assisted quality checks
Fact-Checker
Claim verification against your source documents
AI accelerates. Our experts validate.
Every output goes through expert medical review before it reaches your team. AI handles structure and speed — we handle scientific judgement and MLR readiness.
// RWE study data capture monitoring
monitor("rwe_study_site_data.json", {
mode: "quality_check",
sites: 6,
output: "quality_dashboard + anomaly_alerts",
})
Monitoring data quality across 6 study sites...
Quality Dashboard
6 sites active. 847 records collected. Site 3: 12% missing data (above threshold). Site 5: 3 outlier values flagged. Overall completion: 68%. Estimated study close: 8 weeks...