Clinical Study Subject Narratives
Guidelines issued by regulatory agencies and the International Conference on Harmonization (ICH E3 and E6) define stringent sponsor responsibilities for safety assessment and reporting in clinical studies, including narrative statements on special categories of adverse events for individual subjects. Accovion’s expert Medical Writers in cooperation with the project team can produce detailed subject narratives tailored to the particular safety concerns of your clinical study report and submission.
Ensure your study reports and submission are in full regulatory compliance, including all required individual subject narratives. Accovion will work with you to present high-quality subject narratives that are in compliance with ICH Guidelines, written to your specifications, and that support your submission.
Solutions for Your Study
Accovion can help you identify special considerations and provide workable solutions for the creation of subject narratives according to the size and special requirements of your study and submission timelines. These considerations can include:
- Medical Writing resources and project management
- Definition of appropriate narrative criteria
- Programming and automation of narrative generation, particularly in large studies
Integrated Team Approach
Creating subject narratives requires an integrated team approach. Accovion can provide Medical Writers who will work in close cooperation with your experts and can provide one or more of the following additional services to compliment your team:
- Medical Services
- Regulatory Consulting
- Statistical Programming
- Electronic Publishing
Count on Accovion for the resources you need to ensure fully compliant, high-quality subject narratives completed on time and to your specific requirements.