Agile Medical Writing Support for Biopharma Company

This case study outlines the engagement of Veristat by a clinical-stage biopharmaceutical company to provide medical writing and project management services for a New Drug Application (NDA). Initially seeking strategic biostatistics and programming consulting, the client expanded the collaboration to include medical writing and project management due to the complexities involved in their NDA submission. Veristat's medical writing team was tasked with developing a Summary of Clinical Safety (SCS) under a tight timeline. The case study details the strategies employed by Veristat, including comprehensive medical writing, a strategically developed timeline, and effective governance and communication practices. These efforts significantly alleviated the client's document review burden, enabling timely submission of the NDA. Veristat's approach included breaking down the SCS into manageable sections and maintaining regular communication with the client to ensure transparency and efficiency throughout the process. The successful completion of the SCS facilitated the client's submission ahead of schedule.