medical writing

  • Informed Consent Forms and Patient Understanding: Enhancing Accessibility from a Medical Writing Perspective

    An educational narrative review from a medical writing perspective By Femi Fajimi | 26 May 2026 Abstract Informed consent forms (ICFs) are foundational to ethical clinical research, designed to protect voluntary participation and autonomous decision-making. However, modern ICFs have evolved into lengthy, dense documents filled with complex scientific, legal, and regulatory terminology that vastly exceed…

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  • 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…

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  • 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…

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  • 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…

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