Delivering DSUR Excellence for Multinational Biopharma

This client’s annual book of work had steadily increased year on year. They required support to author over 50 simple to complex DSURs annually.

This posed several challenges:

• Overlapping Timelines: DSURs were distributed throughout the year based on their respective Data Lock Points (DLPs), resulting in overlapping timelines for multiple deliverables.
• Complex Processes: The client’s internal systems and well-defined, yet intricate, processes required the Safety/PV writers to seamlessly align with their established workflows.
• Cross-Functional Collaboration: Each DSUR required close collaboration with a dedicated core team and multiple stakeholders across different functional areas beyond Safety/PV.
• Stringent Quality Standards: Each DSUR needed to undergo three rounds of Quality Control (QC) checks at key milestones before finalization, approval, and submission stages.

These challenges required efficient project management to ensure timely and high-quality document submissions.

We implemented practical strategies to ensure seamless execution of the DSURs:

1. Dedicated Team of Writers: A group of seven experienced Safety/PV writers was assigned to the project, with each writer managing 6–8 DSURs over the course of the year.
2. Organizational Tools: Our team used Microsoft Planner to track overlapping timelines, manage QC rounds, and visualize resource flexibility and availability. This ensured smooth execution and accountability across all deliverables.
3. Standardized Communication: To enhance efficiency, the team employed standardized email templates aligned with each document milestone. This practice streamlined communication and reduced delays.
4. Regular Touchpoints with the Client: Internal meetings and frequent touch points with the client resulted in a collaborative and cohesive relationship. This ensured alignment with client expectations and helped address any challenges proactively.

Despite the complexity of overlapping regulatory submissions, our team successfully delivered all DSURs for the year without any delays. The efficient planning, meticulous execution, and close collaboration with the client enabled the team to:

Our structured and agile approach transformed what initially seemed like an overwhelming task into a manageable and successful engagement.

Our experienced team of Safety/PV writers can help you navigate the challenges of overlapping regulatory timelines and complex deliverables. 立即联系.