A medium-sized biotech faced a tight deadline: a comprehensive Clinical Study Report (CSR) shell and first draft were needed in just two weeks, compared to the industry norm of six or more. The project was further complicated by complex oncology study design and data in less-than-ideal formats.

Synterex’s Solution:
Leveraging AgileWriter™, Synterex trained an AI model in real time, mapping planned content to a CSR template and SDTM datasets. As new information arrived, the model was incrementally refined, with a medical writer overseeing the process to ensure quality and compliance.