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Pharmacovigilance – Narrative Writing

Case narrative writing is an important part of pharmacovigilance and patient safety. Case narratives are required for Individual Case Study Reports, from both clinical studies and post-marketing studies. Our team ensures the completeness, chronology and sufficient details in a narrative so that the reader is able to conclude. It provides a summary of events to readers, who do not have access to original data sets. During the course of safety data management, it is seen and used by various groups, such as:

Case reviewers to decide seriousness.
Affiliated companies to triage for their countries during preparation of PSURs
Summary reports by regulatory authorities.

GAP has a qualified team of safety reviewers and experts in narrative writing. Safety reviewers at GAP follows typical format of narrative that is easily understandable and provides the summary of case in short. The feedback and quality analysis of narratives by medical review team is provided to safety reviewers, on a regular basis to generate the best quality narratives in cases.