Certara Synchrogenix Narrative Writing Services
Mitigate risk of inconsistencies and costly delaysNarrative 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
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 CoAuthor to efficiently manage thousands of narratives to full completion, including incorporation of review feedback, 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
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)
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.
Our Team
Gabriella Mangino
Product Manager, Synchrogenix
Trevor Standish
Product Director
Gabriella Mangino
Product Manager, Synchrogenix
Trevor Standish
Product Director
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 is a Product Director with over ten years of experience in creating and implementing innovative software products across various industries, including pharmaceuticals, finance, and marketing. He is a customer-focused team leader with expertise in various areas such as product SDLC management, UI/UX design, AI/ML systems, and innovation.
Trevor has extensive experience in managing software development life cycles, defining global product strategy and roadmaps, and leading teams in the transition to Agile methodologies. He has presented at various industry conferences, assisted global sales teams, and presented at executive roundtables.
He has held positions at Certara, Concentric, Synchrogenix, and Fifth Third Bank Corp., where he demonstrated strong leadership skills, managed product portfolios, and defined strategic product roadmaps.
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 is a Product Director with over ten years of experience in creating and implementing innovative software products across various industries, including pharmaceuticals, finance, and marketing. He is a customer-focused team leader with expertise in various areas such as product SDLC management, UI/UX design, AI/ML systems, and innovation.
Trevor has extensive experience in managing software development life cycles, defining global product strategy and roadmaps, and leading teams in the transition to Agile methodologies. He has presented at various industry conferences, assisted global sales teams, and presented at executive roundtables.
He has held positions at Certara, Concentric, Synchrogenix, and Fifth Third Bank Corp., where he demonstrated strong leadership skills, managed product portfolios, and defined strategic product roadmaps.