Investigational New Drug Application
Investigational New Drug Application: What, Why, and How? An Investigational New Drug Application (INDA) is a request form to the Food and Drug Administration (FDA) from the clinical study sponsor’s
What to Consider while Writing Patient Safety Narratives
What to Consider while Writing Patient Safety Narratives Patient safety narratives (PSNs) are an important component of the clinical study reports (CSRs). These narratives contain clear and concise descriptions of
Clinical Study Report Shell: A
Clinical Study Report Shell: A Comprehensive Guide The clinical study report is an essential part of the regulatory submission process. Its writing and finalization are important milestones. Company sponsors try
Informed consent forms
Informed consent forms Role of language and wordings in building an effective informed consent form A language-based approach to creating and interpreting informed consent forms Informed consent form is a
Standard Operating Procedures in the
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What is the Clinical Trial Protocol?
What is the Clinical Trial Protocol? Introduction to Clinical Trial Protocol The clinical trial protocol is an essential document for the successful conduct of a clinical trial. As per the