Regulatory Classification

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.
Regulatory Requirements for Germany

[Click on the Image for Germany Example]

Regulatory Requirements

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

Global Study Overview

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

NIS Term Checker

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

Regulatory Green Light

Initiate sites with confidence.

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

Regulatory Compliance

Be Audit and Inspection Ready.

  • Create a regulatory compliance checklist for your study

Regulatory Updates 

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

Ask An Expert

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

Regulatory Database

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