Set the reporting scope
Confirm the Development International Birth Date, annual reporting period, data lock point, investigational product, and applicable program scope.
NARRATIVA · REGULATORY
DSUR Automation with AI Agents
Bring global clinical-trial safety findings and cumulative development data into a structured Development Safety Update Report—with source-aware drafting.
AI AGENTS TRUSTED BY LIFE SCIENCES ORGANIZATIONS
DSUR · COORDINATED AI AGENTS
Scope. Synthesize.
Review with confidence.
Purpose-built agents help clinical safety and regulatory teams organize the annual reporting-period evidence, connect findings across studies, and prepare a traceable draft for qualified review.
Gather global safety evidence
Bring together configured trial, serious adverse event, literature, nonclinical, and other relevant development safety sources with provenance.
Organize findings in context
Structure new safety issues, serious events, important risks, and study-level context to support review across the development program.
Summarize cumulative exposure
Bring participant exposure into view across studies, treatment duration, and dose groups using the program’s approved data sources.
Draft the structured report
Organize source-grounded content into the DSUR structure and configured sponsor templates, with sections ready for author review.
Validate and review
Support consistency, source verification, and revision tracking while qualified safety and medical experts interpret findings and approve content.
MEDICAL AUTHORING COMPANION · CLINICAL DEVELOPMENT
See the annual safety picture across the development program.
A Development Safety Update Report (DSUR), described in the ICH E2F guideline, is an annual report on safety information for a drug under development. It brings together relevant findings from clinical trials and other sources over the reporting period, alongside cumulative information and the investigational product’s development context.
Medical Authoring Companion helps teams organize approved safety materials, prepare structured report drafts, and trace statements to source evidence. Qualified safety and medical experts remain responsible for evaluating the evidence, conclusions, and final review against applicable requirements.
DSUR · FAQ
Development safety reporting, step by step.
Learn how source-aware AI workflows can support annual safety report preparation and qualified review.
What is a DSUR?
A Development Safety Update Report is an annual safety report for a drug under development. ICH E2F describes a common structure for presenting relevant safety information from clinical trials and other sources in the context of the ongoing development program.
How can AI agents support DSUR preparation?
Agents can help organize approved source materials, structure report sections, draft source-grounded summaries, and run configured consistency or traceability checks. Qualified safety and medical experts review and interpret the evidence and approve the report.
What information can be included in a DSUR workflow?
Configured workflows may bring together clinical trial safety findings, serious adverse event data, cumulative exposure, nonclinical findings, literature, development status, reference safety information, and relevant prior reporting. Teams define the authoritative sources and reporting scope.
How are the reporting period and cumulative data handled?
The workflow can keep reporting-period findings distinct from cumulative development information, retain study and date context, and connect summaries to source evidence. The applicable Development International Birth Date, data lock point, and reporting requirements are set by the responsible team.
Can AI determine whether a safety finding changes the trial or development plan?
AI can help assemble and summarize evidence for review, but qualified safety and medical experts are responsible for interpreting findings, assessing their significance, and determining any actions under the sponsor’s procedures.
How is report quality and traceability supported?
Source links, structured drafting, and configured quality checks can help reviewers verify statements, identify inconsistencies, and manage revisions. Final validation and submission readiness remain subject to organizational procedures and applicable regulatory requirements.