clinical trials – 'Femi Fajimi

May 13, 2026

ICH E6(R3): If E6(R2) Was Already Effective, Why Do We Need R3?-A Medical Writer’s Perspective

ICH E6(R3): If E6(R2) Was Already Effective, Why Do We Need R3?-A Medical Writer’s Perspective By Femi Fajimi | 13 May 2026 (Educational content. No confidential information included.) Introduction International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (GCP) guidelines have long served as the ethical and scientific foundation…

Writing Patient Narratives in Clinical Trials: A Beginner’s Guide

Writing Patient Narratives in Clinical Trials: A Beginner’s Guide By Femi Fajimi | 22 April 2025 When I started exploring regulatory medical writing, one document type I kept coming across was the patient narrative. At first, I thought it would be a simple case summary, but I quickly discovered that writing a good narrative is…

Understanding Informed Consent Forms (ICF)

Understanding Informed Consent Forms (ICFs) By ‘Femi Fajimi | 24 April 2025 Informed Consent Forms (ICFs) are at the heart of ethical clinical research. They represent the intersection between science, ethics, and patient communication. As I learn and grow in regulatory medical writing, I appreciate the depth and responsibility of developing these documents. Although I’m…