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

Investigator’s Brochures are essential in drug development, providing regulatory agencies and clinical investigators with a comprehensive summary of clinical and nonclinical data. Managing multiple IBs simultaneously presents significant challenges — from coordinating cross-functional teams to maintaining version control and meeting submission deadlines. This large biotech faced inefficiencies, poor visibility, and regulatory risk due to fragmented processes. Certara’s project management expertise brought structure, efficiency, and compliance to the process, enabling the client to meet timelines with greater confidence and expand Certara’s role into additional oversight responsibilities.

A leading biotech company faced growing pressure to manage the development and annual updates of up to 15 Investigator’s Brochures (IBs) simultaneously—essential regulatory documents that summarize clinical and nonclinical data for investigational drugs.

These updates required input from cross-functional teams, strict version control, and tight alignment with submission timelines.

Challenges included:

• Poor visibility into IB statuses and deliverables
• Unclear roles and responsibilities across stakeholders
• Frequent delays, heightening regulatory risk
• Ineffective communication of submission risks
• No centralized system for managing workflows

The volume and complexity made manual tracking and ad hoc coordination unsustainable, compromising compliance and efficiency.

In October 2024, the client engaged Certara to lead nonclinical project management for IB development. A dedicated project manager implemented structured oversight and streamlined workflows to ensure timely, accurate, and compliant submissions.

Key Actions:

• Centralized Oversight of all IBs to align timelines and deliverables
• Custom Dashboards for real-time status tracking across programs
• Cross-Functional Leadership to ensure clarity, accountability, and timely follow-through
• Training & Mentorship to empower the nonclinical writing team
• Proactive Risk Management to identify submission risks early
• Workflow Optimization using SharePoint and process improvements

Certara Services

• Project Management

Client Impact

• Reduced IB submission delays and improved tracking
• Increased team alignment and meeting efficiency
• Empowered writing staff with training and mentorship
• Enhanced submission readiness through improved workflows
• Strengthened client confidence, expanding Certara’s role to include nonclinical DSUR oversight