PHOENIX FUNDAMENTALS

The ULTIMATE GUIDE to regulatory compliance for real world research, with PRACTICAL INSIGHTS and informative CASE STUDIES

Regulatory Compliance

Regulatory Compliance Simplified – Surprisingly Simple Steps to Prevent Critical Mistakes and Set your Study Up for Success

Study-Classification-123

Discover How to Classify Your Study with Confidence

Real World Research (RWR)

Real-World Research (RWR) – Simple Studies that Present Unique Challenges and Deliver Important Outcomes

Real-World Research Studies – A Complex Confusion of Country-Specific Terms and Definitions…That All Mean the Same Thing…Almost

Interventional vs Non-Interventional

Interventional vs Non-Interventional – Common Misunderstandings and Simple Solutions

Clinical Trial vs Clinical Study

Clinical Trial vs Clinical Study – Synonyms or Significant Differences?

NIS Considerations

NIS Considerations – Conquering the Complex Simplicity of Non-Interventional Studies

GxPs for NIS and Observational Studies Observational Studies

GxPs for NIS and Observational Studies – Quick Reference Guide

Post-Authorisation Safety Studies - Quick Refernece Guide

Post-Authorisation Safety Studies (PASS) – Quick Reference Guide

S`afety Reporting Requirements for NIS

Safety Reporting Requirements for NIS – Quick Reference Guide

TMF Index for Observational Studies

TMF Index for Observational Studies – Sick and Tired of Trying to (Painfully) Force your Observational Documents into a Filing System Designed Specifically for Clinical Trials?

Useful-Links

Useful Resources – For When You Need Sources Instead of Solutions