Accelerating Oncology Drug FDA Submission with Project Management Services

An emerging biopharmaceutical company was developing a first-in-class oncology drug to treat a specific type of liquid tumor. With Phase 1 and 2 trials completed, the company aimed to secure FDA approval through the accelerated Real-Time Oncology Review (RTOR) program.​

To meet this ambitious goal, the company faced a highly compressed submission timeline—demanding seamless coordination, rapid data integration, and parallel execution across clinical pharmacology, pharmacometrics, regulatory, and cross-functional teams.

Certara supported the Clinical Pharmacology program with Population PK modeling, Exposure-Response modeling, and Non-Compartmental Analysis. A dedicated project manager provided end-to-end support to the company by:​

• Accelerating Timelines: Developed innovative strategies, prioritized critical-path tasks, and ensured timely project delivery.​
• Coordinating a Large Team: Aligned efforts across data programmers, modelers, clinical pharmacologists, and medical writers, managing communication, timelines, resources, budget, and risk.​
• Ensuring Clear Communication: Worked closely with the company’s program manager to coordinate tasks, lead regular status updates, and track decisions through detailed logs.​
• Optimizing Resources and Budget: Ensured the right expertise was available when needed and maintained budget discipline throughout the project.

• Accelerated Submission: Timeline shortened by two months.​
• High-Quality Outcomes: Deliverables met FDA standards, supporting approval.​
• Seamless Execution: Proactive management and strong collaboration with the company ensured efficient, on-track delivery.