Narrative writing tool - Overview
Narratives are created based on various sources of clinical data collected during the study. These sources include Council for International Organizations of Medical Sciences (CIOMS) forms, Case Report Forms (CRFs), MedWatch forms, Data Clarification Forms (DCFs), and Clinical database listings. Drafting narratives manually presents numerous challenges, including resource constraints, inconsistencies in content, diverse data sources, and time-intensive processes.
At Freyr, we are committed to delivering innovative solutions that streamline the narrative writing process, enhance data transparency, and support Regulatory compliance. Our solutions automate time-consuming manual tasks associated with narrative writing, allowing your team to focus on strategic activities and accelerating the submission process.
Freyr has meticulously designed a narrative writing tool that will maximize the accuracy, consistency, and reliability of patient safety narratives for Regulatory submissions.
Contact us today to learn more about how our patient safety narrative solutions can elevate your organization’s Regulatory submissions and advance your drug development initiatives.
Narrative writing tool
- Preparation and review of patient safety narratives
- Quality control of the data and scientific information
- Vast experience across multiple therapeutic areas like oncology, neurology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
- Complete understanding of the critical importance of patient safety narratives in Regulatory submissions
- Defined processes of thorough scientific, medical, editorial, and in-house quality control review before the sponsor review
- Expertise in patient safety narratives
