Confirm the regulatory classification of your study with our decision trees

• The regulatory classification is important because it is the starting point for identifying the regulations and guidelines applicable to your study.

[Click on the Image for Germany Example]

Confidently start-up credible real world research studies with our country-specific ‘Regulatory Requirements’ tool.

• 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

Generate an overview of the regulatory requirements and operational considerations for you study.

• Easy to use
• Great visual overview
• Can be used to simulate how changes to countries and/or regulatory assumptions impact your study timelines etc

Ensure your key documents (e.g., protocol and informed consent forms) are using NIS appropriate terminology.

• Purpose is to remove words and terms that are not relevant for NIS (e.g., IMP, GCP, SUSAR) and thereby removing red flags that are likely to increase IRB/IEC review time and/or raise questions and concerns
• Highlights inappropriate terms and suggests alternatives

Initiate sites with confidence.

• Regulatory green light checklists for non-interventional study sites in the country of interest
• Specific to study types

Be Audit and Inspection Ready.

• Create a regulatory compliance checklist for your study

Regulatory Intelligence for Real World Research

• Keep up to date with important changes to real world research regulations and guidelines
• Avoid that awkward auditor question…”How do you keep up to date with the relevant regulations and guidelines?”
• Sign up for our monthly digest of what’s changed and what’s new in the context of real world regulations and guidelines.
• Updates prioritised by impact:

  • Significant Update  = Will have an impact on the regulatory requirements for conducting real world research studies in the country of interest

  • Moderate Update  = May have an impact on the regulatory requirements for conducting real world research studies in the country of interest

  • Minor Update  = Has little or no impact on the regulatory requirements for conducting real world research studies in the country of interest

Real Experts. Rapid Results.

• NIS are a confusing conundrum of simplistic design and complex, country-specific regulatory requirements…we’re here to help
• Sign up for ad hoc consulting or a monthly retainer…it’s entirely up to you

RWR Regulatory Database – Integration with Existing Systems

• Do you want access to our global regulatory intelligence database, but already have your own system?
• No problem…we can work with you to upload our data into your system
• Includes regulatory information for real world research studies (e.g., NIS, PASS etc) in 56 countries
• Country-specific regulatory topics covered include:
  • Study classification
  • Study start-up requirements (approvals, notifications, registration, timelines, fees)
  • Annual reports
  • Substantial and non-substantial amendments
  • Operational considerations
  • End of study notifications
  • Final study reports
  • Archiving