Every submission tells a story, but Development Safety Update Reports (DSURs) require a special kind of narrative. They blend clinical development history, emerging safety data, and a forward-looking benefit-risk assessment. At TrialAssure, we’ve refined our DSUR approach with a focus on clarity, efficiency, and consistency, shaped by real-world engagements with clients across the spectrum. 

In recent months, our experts have been working behind-the-scenes to build better DSUR capabilities through collaborative, Sponsor-level work that has helped us streamline our base template, refine our prompts, and deepen our ability to support both first-time and repeat reports. While this work began as a pilot project, the impact will be long-lasting.  

Today, we’re better equipped than ever to support better DSUR preparation in ways that reduce the burden on internal teams while enhancing accuracy and alignment with regulatory expectations. 

Our approach to building better DSURs includes: 

• Customized templates that work for both first-ever DSURs and subsequent annual updates, with built-in flexibility to leverage earlier DSURs as foundational material. 

• Source-specific prompts that connect directly to over 25 content types, including protocols, Investigator’s Brochures, strategy documents, literature, and clinical data outputs – plus the ability to customize your own. 

• More than 70 embedded prompts tailored to the document structure, including specialized content guidance for Executive Summaries and Appendices. 

• Integrated data analytics that help transform TLFs into summary tables through smart ingestion and formatting. 

• Consistency and clarity across DSURs, driven by repeatable structure, reduced rework, and clearer review paths. 

As the demand for high-quality safety documentation grows, the TrialAssure team continues to invest in smart frameworks that support efficient, compliant, and high-impact DSUR delivery. We welcome conversations with drug safety and pharmacovigilance teams who are looking for a strategic partner to elevate their writing processes and document outcomes. 

Practical Tips for Strengthening DSUR Development 

For companies preparing DSURs across multiple investigational products or geographies, even small improvements in approach can create major time savings and downstream clarity. Below are effective practices that medical writing teams can adopt to build better DSURs: 

1. Establish cross‑functional coordination early: DSUR preparation requires input from pharmacovigilance, regulatory affairs, clinical data management, biostatistics, and medical writing departments. Engage each function early so that data pulls, safety‑case listings, study‑exposure summaries, and narrative inputs align with the document timeline. 

2. Use standardized templates and structured prompts: A consistent template and prompt set help ensure all required sections are covered, reduce duplication, and support efficient content reuse. Lean authoring techniques save time and make reviews smoother. LINK AI can be a great technology resource here.  

3. Recognize and align with global DSUR content scope: The ICH E2F guideline defines key content for DSURs including clinical trials, non‑clinical studies, literature, manufacturing changes, and marketing‑experience data when relevant. Review the reporting period, data‑lock point, and included studies carefully. 

4. Leverage prior reports when applicable: For annual DSURs, previous reports serve as a foundation. Using them as source material supports consistency, efficiency, and narrative continuity. For first‑time DSURs, teams should establish a clear base of historical data. 

5. Focus on clarity in the Executive Summary and Overall Safety Assessment: The Executive Summary should stand alone and require minimal review. The Overall Safety Assessment must link data, risk‑benefit thinking, and emerging safety trends in a clear and concise way. 

6. Prepare for tight timelines and evolving data: The annual reporting schedule often allows just 60 calendar days after the data‑lock point. Build rolling reviews, early data uploads, and real‑time collaboration into your work plan to stay on track. 

7. Use automation and analytics to support efficiency: Integrate data feeds, automated tabulations, and pre‑populated tables based on TLFs (Tables, Listings, Figures) to reduce manual effort and data‑entry errors. This frees writers to focus on interpretation and narrative rather than repetitive tasks.  

Looking Ahead 

Drug safety reporting is undergoing a transformation as clinical trial complexity grows and regulatory expectations shift toward higher-quality benefit-risk communication. As an industry, it is easy to see that DSURs are just as many tools for strategic insight as they are for compliance. With TrialAssure’s enhanced approach, Sponsors have a smarter, faster path forward that honors both the science and the story behind every product. 

We invite regulatory, safety, and medical writing teams to explore how our purpose-built approach to DSURs can support stronger documents, smoother processes, and more efficient use of internal resources. 

Let’s build better DSURs, together. 

For questions related to DSURs, connect with Zach and the team here.