clinicaltrials
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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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An educational narrative review from a medical writing perspective By Femi Fajimi | 18 May 2026 Abstract Clinical trial lay summaries have emerged as important tools for improving transparency and public understanding of clinical research following increasing regulatory emphasis on patient-focused communication. Regulatory frameworks such as the European Union Clinical Trials Regulation (EU CTR) No.…
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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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Avoiding Type I Error Misinterpretation in Clinical Study Reports: A Practical Perspective from Medical Writing By Femi Fajimi | 15 April 2026 (Educational content. No confidential information included.) In clinical trials, control of Type I error is a statistical responsibility defined in the protocol and the Statistical Analysis Plan (SAP). However, the interpretation and communication…
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Writing Lay Summaries: What I Didn’t Expect to Learn as a Regulatory Writer By Femi Fajimi | 27 November 2025 (Educational content. No confidential information included.) Introduction When I started learning regulatory medical writing, I assumed that lay summaries were “scientific findings rewritten in simpler language.” I expected the usual tasks: reducing jargon, shortening sentences,…
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From “Raw TFLs” to Regulator-Ready Narratives: A Medical Writer’s Walkthrough (Antifungal Case Study) By Femi Fajimi | 10 September 2025 (Educational content. Drug, data, and outputs below are fictional but formatted to mirror real deliverables.) Introduction Sometimes, when I am asked to support some freelance writers with their ongoing projects, particularly when it involves reviewing…
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Understanding the Paediatric Investigation Plan (PIP): How It Differs from a Clinical Trial Protocol
Understanding the Paediatric Investigation Plan (PIP): How It Differs from a Clinical Trial Protocol By Femi Fajimi | 02 June 2025 Introduction When I first heard the term Paediatric Investigation Plan (PIP), I assumed it was just a clinical trial protocol for children. But I soon realised it’s a much broader regulatory tool, one that…
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From Numbers to Narrative: Learning to Understand Clinical Data as a Medical Writer By ‘Femi Fajimi | 22 May 2025 One of the most valuable skills I’m developing as a regulatory medical writer is the ability to interpret clinical data clearly and accurately. I’m learning that writing about trial outcomes isn’t just about listing results…
'Femi Fajimi 