clinical trial documentation
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Understanding Pre-Clinical Modules of the CTD – A Dermalexiin Case Study By Femi Fajimi | 02 July 2025 Introduction: The CTD and Its Pre-Clinical Modules Regulatory medical writers often encounter the Common Technical Document (CTD) format when preparing submissions for new medicines. The CTD is organised into five modules, where Module 4 compiles all pre-clinical (nonclinical)
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The Investigational Medicinal Product Dossier (IMPD): An Overview from a Developing Medical Writer By Femi Fajimi | 23 June 2025 Regulatory medical writing requires a blend of scientific insight, structured communication, and regulatory awareness. As a developing writer, I’ve come to realise that the work extends beyond writing well; it’s about presenting data, safety, 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,
'Femi Fajimi 