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Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs)—or PBRERs, the Periodic Benefit-Risk Evaluation Reports—are some of the most critical, complex, and data-intensive regulatory documents in the drug lifecycle. These reports demand the seamless integration and synthesis of vast amounts of safety data, clinical trial outcomes, and post-marketing experience to provide a periodic, global evaluation of a product’s benefit-risk profile.

The complexity of aggregating data, conducting risk analysis, and drafting these reports manually often leads to prolonged timelines and a heavy burden on safety and regulatory teams.

At AlphaLife Sciences, we have specifically engineered our flagship AuroraPrime RMA (Regulatory and Medical Authoring) platform to automate the creation of DSURs and PSURs, streamlining data integration, accelerating risk analysis, and dramatically reducing submission timelines.

The Challenge: Data Aggregation and Analysis Bottlenecks

Creating a DSUR or PSUR/PBRER requires gathering information from diverse, often disparate, internal and external sources. These sources include clinical trial datasets, registries, commercial information, Investigator's Brochures (IBs), literature, ICSRs, and core safety information (CCDS, CCSI).

The traditional process involves:

1. Data Collection and Preparation: Extracting and processing clean safety data from pharmacovigilance (PV) systems, processing literature, and exporting data as lists and tables.

2. Document Authoring: Summarizing the risk/benefit profile using the analyzed data and synthesizing content.

This cross-functional effort is highly collaborative, involves diverse data processing, and requires sophisticated data interpretation—all contributing to significant manual burden and long document cycle times.

The AuroraPrime Solution: Intelligent, End-to-End Safety Automation

AuroraPrime RMA is an AI writing solution designed to revolutionize how organizations create and manage their regulatory documents, including DSURs and PSURs. By automating the end-to-end authoring workflows for these critical regulatory documents, AuroraPrime enhances efficiency and significantly accelerates timelines.

Here is how AuroraPrime transforms DSUR and PSUR/PBRER creation:

Streamlining Data Integration and Synthesis

The platform tackles the challenge of data fragmentation by providing Unified Data Integration & Ingestion.

• Multimodal Data Ingestion: AuroraPrime efficiently incorporates diverse data types—including structured safety data, tables, figures, listings (TFLs), and unstructured regulatory communications—from various sources.

• API-Driven Connectivity: AuroraPrime RMA offers robust API-based and connector-driven integration with safety databases, clinical trial management systems, and publication libraries. For PBRER specifically, inputs typically include Individual Case Safety Reports (ICSRs), sales data, clinical trial datasets, literature databases, and regulatory communications. This connectivity eliminates manual data transfers, ensuring accuracy and efficiency.

• Automated Data Handling: The platform natively ingests large datasets, tables, figures, and listings (TFLs), automatically formatting and mapping them into the appropriate PBRER sections.

Accelerating Risk Analysis and Regulatory Drafting

The core strength of AuroraPrime lies in using GenAI to accelerate the analysis and drafting phases for DSURs and PSURs.

• Automated Draft Generation: AuroraPrime uses AI-enabled templates tailored for DSUR and PSUR documents. This feature automates content creation by synthesizing aggregated safety data and upstream documents, enabling the rapid generation of comprehensive drafts.

• Periodic Content Updates: This capability is especially valuable for PBRERs, which require updates to specified sections at regular intervals to incorporate new safety or efficacy data affecting the drug’s benefit-risk profile. The system monitors linked source materials and automatically triggers revisions or new drafts when upstream changes occur, minimizing manual oversight.

• DSUR and PSUR Specific Automation:

• DSUR Writing Automation automates data aggregation from multiple sources, accelerates risk analysis, and drafts DSUR narratives, ensuring alignment with current regulatory guidelines.

• PSUR Writing Automation automates PSUR generation by synthesizing safety data and automating periodic benefit-risk evaluations, streamlining reporting and enhancing accuracy.

• Content Reuse: The platform understands the cross-references between DSUR and PBRER, enabling content (like Worldwide Marketing Authorization Status or Actions Taken for Safety Reasons) to be copied between the two documents, ensuring consistency and maximizing reuse.

Compliance and Quality Assurance Built-in

Since safety documents are highly regulated, AuroraPrime embeds compliance checks throughout the process.

• Regulatory Intelligence: AuroraPrime RMA simplifies compliance by embedding regulatory intelligence into the writing process. This ensures every draft aligns with current guidelines, industry standards, and company-specific rules.

• Built-in GenAI QC: The platform employs a robust AI-powered quality control framework that benchmarks generated content against "golden" standards, performing automated integrity and consistency checks.

• Traceability: AuroraPrime ensures that all AI-generated content is traceable. For patient narratives, hovering over specific sections reveals the original data source (e.g., PV systems).

The Transformation: Speed, Quality, and Focus

By automating the complex data integration, analysis, and regulatory drafting required for DSURs and PSURs, AuroraPrime RMA frees R&D leaders to focus on innovation by automating routine tasks, significantly boosting research efficiency and productivity.

AuroraPrime is specifically designed to support the authoring of critical safety documents like DSURs, PSURs, and Patient Safety Narratives. This comprehensive, end-to-end automation ensures a seamless and efficient process from template initiation to final submission, accelerating timelines and reducing errors.

AuroraPrime RMA is the definitive solution for clinical documentation, enhancing efficiency, ensuring compliance, and accelerating submissions for pharmaceutical leaders worldwide.

Ready to accelerate your safety reporting timelines? Learn how AuroraPrime RMA can transform your pharmacovigilance documentation.