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, Synchrogenix Writer, 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 Synchrogenix Writer

当社の専門家と技術対応のサービス提供を適用することで、安全性レポートを強化します。一貫性を保ちながら、大規模ナラティブプロジェクト完了までの時間を短縮します。

  • Our experts engage Synchrogenix Writer to efficiently manage thousands of narratives to full completion, including incorporation of review feedback, in a fraction of the time
  • データベースロック前のデータを使用してテンプレートを開発/テスト実施。データベースロック後のデータを用いて追加作業をする必要なし
  • Gain quality, consistency, and standardization across your narrative template and submission
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Tech-enabled Synchrogenix Writer
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)
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Client Journey + Technology = Success

We continually make improvements to Synchrogenix Writer, 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.

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Client Journey + Technology = Success
当社のチーム
Gabriella Mangino
Gabriella Mangino Product Manager, Synchrogenix

Gabriella Manginoは、患者ナラティブ制作やプロジェクトリーダーとして製薬会社に長年従事してきました。現在Synchrogenix のプロダクトマネージャーである Manginoは、コマーシャルグループやサービスグループと協力し、当社の技術を駆使したオーサリング機能をサポートするソフトウェアの開発と改善に貢献しています。

Trevor Standish
Trevor Standish Associate Director, Product Management

Trevorは、製品戦略、ロードマップ、要求事項をクロスファンクショナルなチームと共に開発し、ソフトウェア製品の立ち上げを成功させた豊富な経験を有しています。過去10年間、金融、マーケティング、製薬の分野で超革新的な技術を生み出し、進化させてきました。お客様と企業のコラボレーションを重視し、結果を出すためのインセンティブを提供しています。

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