Case Study: a large biotech streamlines Investigator’s Brochures with Certara project management

Large Biotech Streamlines Investigator’s Brochures with Certara’s Project Management Expertise

A large biotech company faced significant challenges in managing the development and annual updates of up to 15 Investigator’s Brochures (IBs) simultaneously. They struggled with poor visibility into project statuses, unclear roles, frequent delays, and ineffective communication, which heightened their regulatory risk. They engaged Certara for dedicated project management support to streamline this critical process.

Certara implemented a centralized oversight system with real-time dashboards and optimized workflows using tools like SharePoint. This solution provided structure and clarity, resulting in reduced submission delays, improved team alignment, and enhanced submission readiness. The success of Certara's support strengthened client confidence and led to an expanded role, including oversight of nonclinical Development Safety Update Reports (DSURs).