Best Practices for Automating the Creation of Adverse Event Narratives
Creating semi-automated adverse event narratives require coordination between many parties within a pharmaceutical organization. Data Management and Biostatistics provide the data, medical writers and medical officers provide guidance for content on a therapeutic area basis and then programming and validation is required to tie all of this together. This presentation will share industry experiences in solving the problem of automating the delivery of adverse event narratives for the clinical study report to medical writers.
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- Experiences in implementing adverse event narratives for multiple therapeutic areas quickly and issues that arise as a result
- Generating adverse event narratives for global clinical trials over several years and several therapeutic areas
- Standardizing tabular data for adverse event narratives for oncology submissions
- Experiences helping organizations meet their goals for automating adverse event narratives.
- Darren Dorrell, HND, Senior Safety Data Analyst, Genentech
- Ashima Bajpaj, Senior Manager of Information Systems, Amgen
- Sarah DiLello, Principal Medical Writer, Incyte
- Geoffrey Mann, PhD, JMP Product Manager, SAS Institute