Blog
Informative articles about all aspects of Medical Writing
Plain Language (Lay) Summaries: From Regulatory Obligation to Thoughtful Transparency
Introduction Plain Language Summaries (PLS) have become a defining feature of modern clinical trial transparency. Under the EU Clinical Trials Regulation (EU CTR), they are mandatory and publicly visible through the Clinical Trials Information System...
The Investigator’s Brochure (IB): A Comprehensive Guide
What is an Investigator's Brochure? The term Investigator’s Brochure (IB) refers to a compilation of the clinical and non-clinical data on an investigational product (IP) that are relevant to the study in human subjects, and that are presented in a concise, objective,...
The Importance of Quality Control (QC) and Review in Medical Writing
High-quality medical writing (MW) underpins the credibility, accuracy, and compliance of clinical and regulatory documents submitted to health authorities. In drug development, even a single error in data, formatting, or interpretation can delay approvals, undermine...
AI in Medical Writing
Artificial intelligence (AI) is reshaping the landscape of medical writing, transforming what has traditionally been a manual, time-intensive process into one that is faster and more consistent. By automating repetitive tasks, improving consistency, and supporting the...
Revolutionising Clinical Study Reporting: An Automated CSR Generator
Clinical Study Reports (CSRs) are vital documents for summarising trial results and ensuring regulatory compliance. They need careful detail and must follow strict guidelines, which can feel overwhelming. As a result, medical writers and researchers can often face...
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