A new Sponsor team with few processes and little project experience in place
A commercial-stage biopharmaceutical company recently employed new team members to support the production of patient safety narratives across the primary and extension Clinical Study Reports (CSR)s. The Sponsor team had not worked with a narrative vendor in the past and was not very familiar with the narrative process overall and how it fit into the overall CSR process. The Sponsor was not sure what source data would be available for the Certara Synchrogenix team to work with, and how to best write to the existing template.
We introduced the narrative builder features within Synchrogenix™ Writer to the Sponsor, explained the data mapping process, and highlighted our writers’ and QCers’ ability to work with the clinical dataset directly. We worked with the Sponsor’s existing template and identified areas for improvement based on the specific study data sets. The Certara Synchrogenix team was able to deliver draft narratives for Sponsor review ahead of schedule while providing the flexibility and support to address any of the Sponsor’s questions along the way. The Sponsor had a very pleasant first narrative experience, and will be working with Certara Synchrogenix on narrative projects in the pipeline.
The narrative builder features in Synchrogenix™ Writer encourage a successful narrative production process from the start. Through providing efficiencies to our production team and expediting the drafting process, the narrative builder features build and secure a first-time Sponsor-vendor relationship throughout the project.
