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Best Practices for Automating the Creation of Adverse Event Narratives

SAS created JMP in 1989 to empower scientists and engineers to explore and analyze data visually. Since then, JMP has grown from a single product into a family of statistical discovery tools, each one tailored to meet specific needs. Among the products is JMP Clinical, which is clinical data analysis software for ensuring trial safety and efficacy. John Sall, SAS co-founder and Executive Vice President, heads the JMP business unit.


概要

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Creating adverse event narratives requires coordination between many parties within a pharmaceutical organization. Data managers and biostatisticians provide the data while medical writers and medical officers provide therapeutic area-specific guidance for content. Programming and validation are then required to tie all of this together. Given this complexity along with significant consequences for inaccuracies or delays, many organizations are seeking ways to streamline this process. This presentation will share industry experiences in meeting the challenge of automating the delivery of adverse event narratives for the clinical study report to medical writers.


特集トピック

  • 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.

参加対象

Professionals who work in the area of:

  • Medical Writing
  • Information Technology
  • Data Management
  • Biostatistics

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