RWR Regs Subscription
Simple Tools…Powerful Results
Created to address the regulatory requirements and operational considerations for your real world research studies.
Regulatory Classification
Classify your study with our regulatory classification decision trees
NIS Regulatory Requirements
Everything you need to run a non-interventional study…in one place.
Country-specific regulatory requirements and operational considerations for the design and conduct of observational drug studies (non-interventional studies).
Per country information includes:
- Study Navigation Dashboard
- Study Classification
- Summary of Requirements
- Study Start-up Requirements
- Study Start-Up Roadmap
- Regulatory Submission Documents
- Study Conduct Considerations
- Useful Links
NIS Training
Learn about the country-specific requirements for non-interventional studies…and keep up to date with our annual refresher training.
Real World Research Regulatory Updates
Keep up to date with changes to global real world research regulations and guidelines with our monthly regulatory intelligence reports…packed with impact assessments, real world research context and insights.
Created for real world research experts by real world research experts.
EU Medical Devices Regulation – Clinical Investigation Roadmaps
Country-specific detailed guidance on the regulatory requirements and operational considerations when conducting clinical investigations and post-market clinical follow-up (PMCF) studies in Europe.
Includes country-specific clinical investigation decision trees and approval roadmaps.
