Are You Ready for Automated DSUR and PADER Generation?

Pharmacovigilance (PV) teams across the life sciences industry are under unprecedented pressure. Regulatory expectations continue to expand, safety data volumes are growing exponentially, and timelines for submission are becoming tighter with little tolerance for error. Among the most resource-intensive and high-risk deliverables in PV are aggregate safety reports, particularly Development Safety Update Reports (DSURs) and Periodic Adverse Drug Experience Reports (PADERs).

Traditionally, these reports have been compiled through highly manual, labor-intensive processes involving multiple systems, stakeholders, and review cycles. While this approach has served the industry for decades, it is increasingly unsustainable in a world where speed, accuracy, and compliance are critical to maintaining both patient safety and business continuity.

Automation is no longer a future concept in pharmacovigilance; it is rapidly becoming a necessity. The question organizations must ask is not whether to automate DSUR and PADER generation, but whether they are ready to do so.

Understanding the Complexity of DSUR and PADER Reporting

DSURs and PADERs are cornerstone regulatory submissions designed to provide a comprehensive, cumulative assessment of a product’s safety profile over a defined reporting period.

A DSUR is required annually during clinical development and includes global safety data, cumulative adverse event analyses, risk–benefit evaluations, and updates on ongoing or completed studies. It demands extensive cross-functional input from clinical, regulatory, safety, and medical writing teams.

PADERs, submitted to the U.S. FDA for approved products, require periodic summaries of adverse drug experiences, including both domestic and foreign cases. These reports must adhere strictly to FDA formatting and content requirements and align with predefined reporting schedules.

Both report types share several challenges:

• Aggregation of large datasets from disparate safety, clinical, and regulatory systems

• Reconciliation of case data, listings, and narratives

• Manual authoring of repetitive sections

• Complex quality control and version management

• High dependency on subject matter experts for interpretation and sign-off

Even a small error or delay can trigger regulatory queries, inspection findings, or compliance risks.

The Limitations of Manual Reporting Approaches

Despite advances in safety databases and case processing tools, many organizations still rely heavily on manual processes for aggregate report generation. Word documents, spreadsheets, copy-paste workflows, and email-driven reviews remain common.

This approach creates several systemic problems:

First, manual data handling increases the risk of human error. Inconsistent numbers between sections, outdated tables, or missing safety signals can compromise the integrity of the report.

Second, timelines become difficult to manage. As data volume grows, teams spend more time extracting, cleaning, and validating information rather than analyzing it. This leaves little room for strategic safety evaluation.

Third, knowledge becomes siloed. Report logic, assumptions, and historical context often reside in individual contributors’ expertise rather than in standardized, auditable systems.

Finally, scalability is limited. As pipelines expand or reporting frequencies increase, organizations struggle to maintain quality without significantly increasing headcount and costs.

These limitations have pushed the industry toward automation as a strategic solution rather than a tactical improvement.

What Does Automated DSUR and PADER Generation Really Mean?

Automation in aggregate reporting goes far beyond auto-filling templates. A truly automated DSUR or PADER solution integrates data, workflows, and intelligence across the entire reporting lifecycle.

Key elements include:

• Direct integration with safety databases, clinical systems, and regulatory repositories

• Automated data extraction, transformation, and validation

• Preconfigured report structures aligned with ICH and FDA guidance

• Dynamic population of narratives, listings, and summary sections

• Built-in version control, audit trails, and compliance checks

• Workflow orchestration for authoring, review, and approval

Advanced automation platforms also incorporate analytics and artificial intelligence to identify trends, flag inconsistencies, and support signal detection.

The result is not just faster report generation, but higher-quality reports that enable PV teams to focus on safety insights rather than administrative tasks.

Benefits of Automating DSUR and PADER Reporting

Organizations that successfully adopt automation experience tangible benefits across multiple dimensions.

Operational efficiency improves significantly. Automated data pulls and standardized content generation reduce report preparation time from weeks to days, or even hours in some cases.

Quality and consistency increase. Automation minimizes transcription errors, ensures alignment across report sections, and enforces regulatory compliance rules consistently.

Inspection readiness is strengthened. Automated systems provide traceability, audit trails, and documentation that regulators expect during inspections.

Scalability becomes achievable. As portfolios grow or reporting requirements change, automated solutions adapt without requiring proportional increases in resources.

Most importantly, automation enables a shift from reactive reporting to proactive safety management. PV professionals can dedicate more time to evaluating risks, identifying signals, and supporting benefit–risk decisions.

Are You Ready for Automation?

While the advantages are clear, readiness for automated DSUR and PADER generation depends on several factors.

Organizations should assess:

• The maturity of their safety and clinical data infrastructure

• The level of standardization in current reporting processes

• Openness to change among PV, regulatory, and IT stakeholders

• Alignment between global and local reporting requirements

• Availability of partners or platforms with proven PV expertise

Automation is most successful when approached as a transformation initiative rather than a standalone technology deployment.

This is where specialized pharmacovigilance technology partners play a crucial role.

How Tesserblu Can Help

Tesserblu is uniquely positioned to support organizations in their transition to automated DSUR and PADER generation by combining deep pharmacovigilance expertise with advanced digital capabilities.

Tesserblu’s approach focuses on end-to-end automation while preserving the scientific and regulatory rigor required for aggregate safety reporting.

Key ways Tesserblu can help include:

Integrated Data Enablement: Tesserblu enables seamless integration with safety databases, clinical trial systems, and regulatory sources, ensuring that DSUR and PADER reports are generated using accurate, up-to-date data without manual intervention.

Configurable Automation Frameworks: Rather than one-size-fits-all templates, Tesserblu provides configurable reporting frameworks aligned with ICH E2F, FDA, and global regulatory guidance. These frameworks can be tailored to product type, development stage, and regional requirements.

Intelligent Content Generation: Through rule-based logic and advanced analytics, Tesserblu automates repetitive report sections while supporting expert-driven medical evaluation where it matters most. This balance ensures efficiency without compromising scientific judgment.

Workflow and Governance Support: Tesserblu platforms support structured workflows for authoring, review, and approval, complete with audit trails and version control. This enhances compliance and simplifies inspection readiness.

Change Management and PV Expertise: Beyond technology, Tesserblu brings pharmacovigilance domain knowledge to help organizations redesign processes, train teams, and adopt automation sustainably. This reduces resistance to change and accelerates value realization.

Future-Ready Scalability: As regulatory expectations evolve, Tesserblu solutions are designed to scale and adapt, supporting additional report types, increased data volumes, and advanced analytics without disruption.

The Strategic Imperative

Automated DSUR and PADER generation is no longer just about efficiency; it is a strategic imperative for organizations committed to patient safety, regulatory excellence, and operational resilience.

Regulators increasingly expect consistency, transparency, and traceability in safety reporting. At the same time, internal stakeholders demand faster insights to support development and commercialization decisions. Manual processes cannot meet these demands at scale.

Organizations that embrace automation today position themselves to respond proactively to regulatory changes, reduce compliance risk, and unlock the full value of their safety data.

Conclusion

The future of pharmacovigilance lies in intelligent, automated, and insight-driven safety reporting. DSURs and PADERs, once viewed as unavoidable administrative burdens, can become strategic assets when generated through automated, compliant, and scalable solutions.

The real question is not whether automation will become the norm, but whether your organization is prepared to lead or be forced to follow.

With the right technology partner and a clear transformation strategy, automated DSUR and PADER generation can deliver faster submissions, higher quality, and better safety outcomes. Tesserblu stands ready to help pharmacovigilance teams take this critical step toward the future. Book a meeting if you are interested to discuss more.