An under-developed template without standardization
A global biopharmaceutical company had several clinical study reports across various therapeutic areas, and no clear idea of the template to develop for each study. The Sponsor had the internal initiative to develop a new template, but didn’t know where to begin.
Certara Synchrogenix worked with the Sponsor’s existing template in one therapeutic area and standardized it to the Sponsor’s unique Style Guide. We mapped this template within the narrative builder features in Synchrogenix™ Writer through a Master Template Configuration, and were able to reuse this template across other studies. By adding, removing, or editing study-specific template sections for each therapeutic area study, we were able to provide the quality and consistency of template standardization that best met the Sponsor’s expansive needs.
Certara Synchrogenix worked with the Sponsor’s existing template in one therapeutic area and standardized it to the Sponsor’s unique Style Guide.
The narrative builder features in Synchrogenix™ Writer provide its users the opportunity to standardize and increase the quality of their templates across all therapeutic areas, with customization abilities based on study-specific needs.