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Certara Synchrogenix Narrative Writing Services

Mitigate risk of inconsistencies and costly delays

Narrative writing is an integral part of medical writing services. Sponsors are asked to deliver large batches of these deliverables in short periods while most traditional methods prove unsuccessful in providing both consistency and quality. This can lead to questions and potential discrepancies in the reporting of a drug’s safety.

Fortunately, through the advancement and use of technology, there are options to deliver patient narratives on time, the right way.

Certara Synchrogenix can guarantee consistency, while working with a hefty team, in a large narrative submission through the use of technology-enabled authoring. Our unique software, CoAuthor, has narrative building features that enable us to map clinical data to narrative templates while setting standards for presentation. We move beyond dragging and dropping in data to also apply sophisticated logic and code to the templates we build-out. The template that is produced guarantees an abidance to the standardization of the data that is pulled in and the surrounding template text. The writing team then uses this template as its base for writing without the need to edit the programmed text. No edits mean no potential to introduce inconsistencies.

You would not be able to tell forty different writers were authoring these. It looked as though one person was writing them! The writers wrote a streamlined and visually-cohesive and consistent story that made reviewing the large set by only a few reviewers extremely efficient. This software is extremely valuable.

– Associate Director, Medical Writing

Tech-enabled CoAuthor

通过应用我们的专业和技术支持的服务交付,为您的安全报告提供助力。减少完成大型叙述项目的时间,同时提供一致性。

  • Our experts engage CoAuthor to efficiently manage thousands of narratives to full completion, including incorporation of review feedback, in a fraction of the time
  • 可以使用预数据库锁定数据开发/测试模板,无需使用后数据库锁定数据进行额外操作
  • Gain quality, consistency, and standardization across your narrative template and submission
获取演示
Tech-enabled CoAuthor
Guaranteeing Consistency in Patient Narratives

Guaranteeing Consistency in Patient Narratives

Implementing technology in your process from the start saves time and money, avoids the need for redo loops, and ensures uniformity throughout drafting efforts. Through the utilization of technology to create a template, paired with the production of samples to align on expectations at kickoff, both the sponsor and writing team come together to embark on preparing the best narratives for the submission.

Requirements:

  • Clinical data (SDTM/ADaMs datasets)
  • Supplemental safety data (i.e., CIOMS)
  • Template mapping/programming step (including a sample review) – can utilize pre-Database lock data

Benefits:

  • Decreased writing and QC time
  • Increased consistency and quality across deliverables
  • Ability to take on high volume in expedited timeframe
  • No need to wait on Statistical Programming group for outputs (PPLs, TLFs)
开始对话

Client Journey + Technology = Success

We continually make improvements to CoAuthor, expanding our software to include more logic, sophisticated mapping, and programming capabilities.

Our narrative team of leads, writers, and quality control reviewers work in the software daily. By identifying areas for improvement, we are developing the best product to support your needs.

READ A CASE STUDY
Client Journey + Technology = Success
我们的团队
Gabriella Mangino
Gabriella Mangino Product Manager, Synchrogenix

Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities.

Trevor Standish
Trevor Standish产品总监

Trevor Standish 是 Certara 产品总监,在制药、金融和营销等多个行业创建和实施创新软件产品方面拥有十多年的经验。他是一位以客户为中心的团队领导者,在产品 SDLC 管理、UI/UX 设计、人工智能/ML 系统和创新等多个领域拥有专业知识。

Trevor 在管理软件开发生命周期、确定全球产品战略和路线图以及领导团队向敏捷方法过渡方面拥有丰富的经验。他曾在各种行业会议上发表演讲,协助全球销售团队,并在高管圆桌会议上发言。

他曾在 Certara、Concentric、Synchrogenix 和 Fifth Third Bank Corp 等公司任职,展现了出色的领导能力,管理产品组合,并制定了战略性产品路线图。

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