複雑な患者プロファイルとナラティブテンプレートの必要性

世界的な製薬企業が、非常に複雑な試験のひとつにおいて、患者プロファイル（PPL）およびナラティブのテンプレート作成をサターラに依頼しました。Historically, the Sponsor’s statistical programming team had generated the PPLs as a resource for reviewers to use during their review cycle but would be unable to do so moving forward. The Sponsor team was seeking a way to make the fully written narrative template easier to write and present to reviewers.

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薬事規制

Products

CoAuthor

Certara employed the narrative builder features in CoAuthor to build out the PPL template for all subjects. We automated complex narrative template sections through advanced software features, pulling from multiple data domains and adding logic and calculations. The PPL and narrative templates were merged, and both were delivered as one cohesive document to the Sponsor team during the review cycle. This resulted in an efficient and streamlined review process of complex data.

The narrative builder features in CoAuthor enabled us to automate complex narrative template sections through advanced software features, pulling from multiple data domains and adding logic and calculations.

The narrative builder features in CoAuthor were built for writers by writers with advanced data and template requirements in mind. Through the application of advanced logic and formatting, no dataset or template is too complicated to handle for our Sponsors’ narrative project needs.