Define the reporting scope
Set the reporting interval and data lock point, and confirm the applicable product, market, and report requirements.
NARRATIVA · REGULATORY
PSUR Automation with AI Agents
Bring periodic and cumulative safety evidence together for a structured PSUR/PBRER—with source-aware drafting, review support, and medical experts in.
AI AGENTS TRUSTED BY LIFE SCIENCES ORGANIZATIONS
PSUR / PBRER · COORDINATED AI AGENTS
Collect. Evaluate.
Report with confidence.
Purpose-built agents help pharmacovigilance and regulatory teams organize reporting-period evidence, build a traceable report draft, and prepare findings for expert assessment.
Gather safety evidence
Bring together approved sources such as case data, clinical studies, literature, and exposure information with provenance.
Review safety topics
Organize new information, signal status, important risks, and actions so medical reviewers can evaluate context.
Assess benefit–risk
Bring relevant safety and efficacy evidence into context for a documented, medically led benefit–risk evaluation.
Build the structured report
Organize source-grounded content into the required report structure and applicable company templates.
Validate and review
Support consistency, source traceability, and version review while qualified pharmacovigilance and medical experts retain approval.
MEDICAL AUTHORING COMPANION · PHARMACOVIGILANCE
Connect the reporting period to the full safety picture.
A Periodic Safety Update Report (PSUR), also known in the ICH E2C(R2) framework as a Periodic Benefit-Risk Evaluation Report (PBRER), brings together safety information for an authorized medicinal product over a defined reporting period. It considers interval findings alongside cumulative knowledge and the product’s benefit–risk profile.
Medical Authoring Companion helps teams gather and organize approved safety evidence, prepare structured report drafts, and trace content to source materials. Pharmacovigilance and medical experts remain responsible for signal interpretation, benefit–risk conclusions, and final review against applicable requirements.
PSUR / PBRER · FAQ
Periodic safety reporting, step by step.
Learn how source-aware AI workflows can support report preparation and expert safety review.
What is a PSUR?
A Periodic Safety Update Report is a pharmacovigilance document that presents and evaluates safety information for a medicinal product over a defined period. Under ICH E2C(R2), the Periodic Benefit-Risk Evaluation Report (PBRER) format supports periodic evaluation of the product’s benefit–risk profile using interval and cumulative information.
How can AI agents support PSUR preparation?
Agents can help organize approved source materials, structure report sections, draft source-grounded summaries, and run consistency or traceability checks. Pharmacovigilance and medical experts interpret the evidence, evaluate signals and benefit–risk, and approve report content.
What information can be brought into the report workflow?
Configured workflows may use approved case information, clinical and non-interventional study findings, literature, exposure data, reference safety information, previous reports, and other relevant product safety sources. Teams define the authoritative sources and reporting scope.
How are reporting interval and cumulative data handled?
The report workflow can keep reporting-period information distinct from cumulative product knowledge, organize each with its reporting context, and connect summaries to source evidence. The applicable data lock point, cut-off, and requirements are set by the responsible team.
Can AI make the benefit–risk conclusion?
No. AI can help assemble and summarize evidence for review, but qualified medical and pharmacovigilance experts are responsible for interpreting safety information and reaching the benefit–risk conclusion.
How is report quality and traceability supported?
Source links, structured drafting, and configured quality checks can help reviewers verify statements, identify inconsistencies, and manage versions. Final validation and submission readiness remain subject to the organization’s procedures and applicable regulatory requirements.