Changing the narrative on narrative writing

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 builder 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

Power your safety reporting by applying our experts and technology-enabled service delivery. Reduce time to completion of large narrative projects while providing consistency.

  • Our experts engage Synchrogenix Writer to efficiently manage thousands of narratives to full completion, including review, in a fraction of the time
  • Templates can be developed/tested with pre-Database Lock data with no additional work required using post-Database Lock data
  • Gain quality, consistency, and standardization across your narrative template and submission
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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 controller 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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Our Team
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.

Beth Miller, Ph.D. Safety Project Manager

Beth Miller has more than 15 years of regulatory and safety writing and project management experience in the pharmaceutical industry. Specialties include writing, editing, and managing safety narrative projects and other regulatory documents. As a Safety Project Manager at Synchrogenix, Dr. Miller is responsible for all aspects of project management for safety and narrative projects, including the development of strategies for organizing and preparing narratives and safety deliverables.

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