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某全球药企委托 Certara 为其高复杂性研究设计患者档案(PPL)与叙述模板。在过去,PPL均由申办方的统计编程团队完成 ,以作为审核者在审核环节中使用的资源,但今后这种方式将无法被继续采用。申办方团队希望寻找到一种方法,可以使完全书面化的病例叙述模板更易编写并呈现给审核者。

Certara employed the narrative builder features in CoAuthor to build out the PPL template for all subjects. 我们借助先进的软件功能,从多个数据域提取数据并添加相应的逻辑和计算,使复杂病例叙述模板的各个部分的制作生成自动化。The PPL and narrative templates were merged, and both were delivered as one cohesive document to the Sponsor team during the review cycle. 由此简化了复杂数据的审核流程,提高了审核效率。

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. 通过应用先进的逻辑和格式,使Synchrogenix™ Writer有能力处理任何复杂的数据集或模板,因此完全能够满足申办方对病例叙述项目的需求。

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