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  • Basic Results and Trial Disclosure Reporting: Transparency in Action By ‘Femi Fajimi | 30 April 2025 As I continue developing as a regulatory medical writer, one key area that stands out is the importance of trial transparency. Clinical research does not end when a study closes; it extends to how results are reported and shared…

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  • Lay Summaries in Clinical Trials: A Beginner’s Perspective on Making Research Understandable  By ‘Femi Fajimi | 29/ April/2025  As a beginner regulatory medical writer, I am learning that writing clinical trial documents involves more than technical precision. Increasingly, regulatory requirements demand that clinical research results be communicated to the public in a clear, factual, and…

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  • Clinical Trial Protocols and Clinical Study Reports (CSRs): A Beginner’s Perspective  By Femi Fajimi | 28 April 2025  As I continue developing my skills in regulatory medical writing, I am learning how essential two key documents are to the clinical trial lifecycle: the protocol and the clinical study report (CSR).  Protocols define a study’s blueprint,…

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  • Investigator’s Brochure and Updates: A Beginner’s Guide  By Femi Fajimi | 26 April 2025  When I first heard “Investigator’s Brochure,” I assumed it was a patient-facing document, perhaps a summary leaflet. However, I soon discovered that the IB is one of the most essential internal documents in a clinical trial.  The Investigator’s Brochure (IB) is…

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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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  • Starting Somewhere

    Starting Somewhere By Femi Fajimi | 21 April 2025  Every journey begins somewhere, and for me, this is it.Welcome to my blog. I’m a healthcare professional with a medical, public health, and oral health education background. Over the years, I’ve worked in both clinical and community-based roles, but what has remained consistent is my interest…

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