Explore: Biological Licence Application (BLA) | Clinical Trial Application Dossier | Narratives | New Drug Application (NDA) | Pregnancy Prevention Plan (or Programme, PPP) | Product Information (PI) | Statistical Analysis Plan (SAP) | Summary of Product Characteristics (SmPC) | United States Prescribing Information (USPI)
- Subject narratives, describing individual subject experiences that need an in-depth description, are an important part of properly reporting what happened during a trial, and need to be presented within the Clinical Study Report (CSR).
- For best readability, narratives should have a common format – concisely laying out the experiences of the particular subjects in an easily comparable manner. But they must also tell the story of each subject’s situation, so a reviewer can adequately assess how the drug may have played a role in the events that took place.
- Trilogy draws on huge experience in preparing hundreds of subject narratives, and is familiar with the reporting expectations of regulators and the need for consistent presentation.
- Trilogy writers can work with your clinical teams to develop a format and template for your narratives to ensure they convey key information in an easy to find manner and effectively describe the subject events. Our writers are experienced in managing the entire process of narrative production from kick-off meeting with the sponsor through interaction with the project team, ensuring on-time delivery, quality and efficiency.