-
From a Regulatory Medical Writer’s Perspective By ‘Femi Fajimi Clinical trial quality is often discussed in terms of compliance: whether the protocol follows Good Clinical Practice (GCP), whether the required procedures are documented, and whether the study records meet regulatory expectations. These remain essential considerations. However, compliance alone does not necessarily establish that a clinical…
-
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…
-
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.…
-
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…
-
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…
-
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,…
-
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…
-
Writing Briefing Documents for Scientific Advice Meetings: A Step-by-Step Guide Using Azidomyxin By Femi Fajimi | 08 August 2025 (Educational content. Azidomyxin is a fictional investigational product.) Introduction: What Is a Briefing Document and Why Does It Matter? In the pharmaceutical development lifecycle, the path from laboratory discovery to patient access is highly regulated. At…
-
Writing Clinical Overviews and Clinical Summaries in Regulatory Submissions: A Regulatory Writing Walkthrough with Oncometherin By Femi Fajimi | 26 July 2025 (Educational content. Oncometherin is a fictional investigational product.) Introduction: Clinical Modules at the Heart of Regulatory Submissions Regulatory medical writers play a pivotal role in preparing the documentation that supports new medicine applications.…
-
Subscribe
Subscribed
Have a WordPress.com account? Log in now.
