Utilizing Synchrogenix™ Writer streamlines the patient narrative process from start to finish. Production is made faster and easier with the use of technology and skilled narrative leads, writers, and Quality Control (QC) reviewers. We partner with Sponsors at kickoff and guarantee we have all components of the process covered through to submission.
We share our full process with our partners, so that you’ll have complete transparency when working with us.
Leading the Kickoff Meeting
Certara Synchrogenix’s narrative leads believe in creating a partnership from the start. Once the agreement is in place, our assigned narrative project lead will schedule a kickoff meeting to make introductions and review all the necessary sources needed, timeline, production steps, and method of delivery to support the project. Our narratives team can provide expert guidance and strategic planning (i.e., timeline creation) for all needs, no matter how high the narrative count, complex the template, or constrained the timeline may be. We listen to and understand our Sponsors’ needs and adjust our approach accordingly. Certara Synchrogenix is committed to supporting all project milestones, and our narrative leads are flexible in scheduling additional meetings throughout the production process as needed.
Working with Study Data
The drafting process begins with receiving the data needed for writing the template. The Sponsor provides the final clinical data set through secured sharing/transport means (note: clinical data may be provided in draft form for template mapping, though final data is needed for final template generation). The Sponsor also provides the safety data and all other supplemental data (i.e., adjudication forms, annotated Case Report Form, Protocol) needed for writing. Our project lead familiarizes him/herself with the data and provides any notes/guidance to the narrative team and the Sponsor regarding study-specific data/parameters to highlight in the template. We do not require final listings or patient profiles to assist with our drafting efforts, as our narrative team is trained to write and QC using the data sets directly.
Developing the Template
The template development step is crucial in ensuring criteria/overall presentation alignment with the Sponsor. The Sponsor provides the internally-approved template to work with, or we work with the Sponsor to develop the template from scratch referencing one of our in-house standard templates. The criteria for writing (i.e., fatal events, serious adverse events, adverse events leading to discontinuation) is defined and applied to the data set to create the Subject List. Within 5-10 business days, we map the template to the appropriate data fields in Synchrogenix™ Writer, apply text and data formatting as needed, and perform QC. The template is saved for future use in other projects in support of the Sponsor.
Producing samples supplements the template development step and is important in confirming example standards/presentation of data prior to writing the full set of narratives. A subset of patients with each criteria, including examples of multiple criteria narratives, is chosen from the Subject List, and usually consists of between 3-5 patients depending on the overall volume. We generate the template outputs for these patients from Synchrogenix™ Writer for the narrative team to work on. The narrative writing and QC team complete drafting of the samples, incorporating other source data into the template as needed, and the project lead delivers them for Sponsor review. The project lead will then schedule a comment resolution meeting as needed to review any comments received, update the template in Synchrogenix™ Writer as appropriate, and provide the final version to the Sponsor for approval. Once the template is approved, the remaining templates are generated from the Subject List and made available to the team to begin full production. Setting aside the time for template and sample review up-front in the process allows our technology and team to produce a higher quality narrative from the start.
Delivering Draft Narratives
A narrative generated from Synchrogenix™ Writer may be fully-automated, requiring no individual manual edits, or hybrid, containing both automated template sections and manually written/edited template sections. Fully-automated narratives are ready for draft review upon generation, while hybrid narratives require the support of the writing and QC team prior to delivery for draft review. It is most efficient for our Sponsor review teams to perform one draft review of the safety narrative prior to finalization/final delivery. Our narrative team has extensive background in various therapeutic areas, accreditations in various medical fields, and technical editing expertise. After any manual edits/additions are made to the template, that content undergoes a full QC. Sponsors have peace of mind knowing all draft narratives delivered for review have also undergone QC. When manual edits are limited, the time to draft delivery is dramatically expedited. Lastly, the narrative undergoes final review by the project lead or other designee prior to draft delivery.
Delivering Final Narratives
The final narratives are provided to the Sponsor in the agreed-upon format, whether that be in individual or combined Word file or PDF, published, or publishing-ready files. We incorporate the comments/edits made on the draft narratives by the Sponsor review team and can provide final drafts on a rolling basis if needed. We can also automate a patient index identifying individual narrative criteria met to be included as part of the submission.
To learn more about Synchrogenix™ Writer and how our team of narrative leads can guarantee consistency, while working with a hefty team, in narrative submissions through the use of technology-enabled authoring: