Creating adverse event narratives requires coordination between many parties within a pharmaceutical organization. Data managers and biostatisticians provide the data. Medical writers and medical officers provide guidance for content on a therapeutic area basis. 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 real-world experiences in solving the problem of automating the delivery of adverse event narratives for the clinical study report to medical writers.

Practitioners from the industry will address:

  • 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.
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