Case Study: a leading biopharmaceutical company accelerates FDA RTOR submission with Certara project management services

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

An emerging biopharmaceutical company developing a first-in-class oncology drug faced the challenge of securing FDA approval through the accelerated Real-Time Oncology Review (RTOR) program. This required seamless coordination and rapid data integration across multiple teams to meet a highly compressed submission timeline. They partnered with Certara for its project management services and clinical pharmacology support.

Certara provided a dedicated project manager who accelerated timelines by prioritizing critical-path tasks and coordinated efforts across data programmers, modelers, and medical writers. This solution shortened the RTOR submission timeline by two months. The high-quality deliverables met FDA standards, supporting approval, and the proactive management ensured efficient, on-track execution.