PSUR, PBRER and DSUR Writing for Sponsors and Licence Holders
Pubrica writes periodic safety reports, including PBRERs, PSURs and DSURs, for clinical trial sponsors and marketing authorisation holders. Our pharmacovigilance writers prepare these reports to ICH E2C(R2) and E2F, scheduled back from the data lock point so that each report meets its submission date. Each report includes a benefit-risk evaluation that compares the position at the start and end of the interval, and is reconciled with the risk management plan and the labelling.
- Scheduled back from the data lock point, rather than forward from the date of the request, so that reports are not submitted late
- Current PBRER format. ICH E2C(R2) replaced the older periodic safety update report format, and we write to the current structure
- An evaluated benefit-risk section, comparing the position at the end of the interval with the position at the start
- Signals tracked across intervals, so that each report follows on from the previous one in the series
- Consistent with the RMP and the labelling, because these documents are read together and any divergence will be questioned
PBRER and PSURIncluded
DSURIncluded
Benefit-risk evaluation sectionIncluded
Line listings and summary tabulationsFrom your safety database
Signal detection as the accountable processYour PV function
Data lock point → assembled → evaluated → drafted → submitted
- Planned from the data lock point
- Current ICH format
- Benefit-risk evaluated
- Signals tracked across intervals
- Reconciled with RMP and labelling
Deliverables
PSUR, PBRER and DSUR Deliverables
Each report covers one product, one interval and one data lock point, and its content is limited to what the safety database holds at lock.
Example from a project planPeriodic reports are most often late because the schedule is built forward from the request date rather than back from the submission date. The data lock point is fixed.
Example from a format checkSection: summary of safety data received during the interval.Evaluation of signals and risk information, characterisation of risks, benefit evaluation and integrated benefit-risk analysis. The tabulations are inputs to the evaluation.
Example from a benefit-risk evaluationThe benefit-risk balance for the product remains positive.Two new signals evaluated during the interval, one closed as refuted and one added to the RMP as an important potential risk with a characterisation study. The balance remains positive; the basis for that statement has changed and the report says how.
Example from a series handoverA report that does not refer to what the previous report said about an open signal will raise questions from reviewers.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Periodic Safety Report Guidelines and Quality Standards
Where your agency or your safety function has a stated position, we follow it.
Periodic benefit-risk evaluation report (replaced the old PSUR format)
The current periodic report structure, organised around evaluation of the benefit-risk position rather than tabulation of cases.
Development safety update report (for products in development)
The annual development-phase report, which covers what was learned about safety during the reporting period and its implications for ongoing trials.
Good pharmacovigilance practices (periodic safety reports)
Sets the EU expectations on scope, timing, format and the relationship between the periodic report and the risk management plan.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our quality management system governs how each document is drafted, reviewed, version-controlled and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a named individual. For this reason, source traceability takes priority over speed in our regulatory writing, and every statement must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our Periodic Safety Report Writing Process Works
We build the schedule back from the data lock point, and every later step follows from it.
Scheduling From the Data Lock Point
We map the lock point, extraction, drafting, review cycles and submission as one sequence and identify the critical path.
Data Assembly
We assemble and reconcile line listings, summary tabulations, exposure estimates and literature from your safety database and other sources.
Evaluation and Drafting
We evaluate signals and risk information, characterise the risks and write the integrated benefit-risk analysis as an evaluation.
Reconciliation and Submission Support
We check the report against the RMP and the labelling, consolidate review comments and deliver the report for your submission.
Our Experts
Our Periodic Safety Report Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
PSUR, PBRER and DSUR Service Packages
Pricing depends on the product, interval length, case volume and whether there is an existing series to continue.
Single report
One PBRER, PSUR or DSUR
Quoted per projectBased on product, interval and case volume
Delivery Delivered to the submission deadline
- ✓Schedule worked back from the data lock point
- ✓Data assembled and reconciled
- ✓Signals and risk information evaluated
- ✓Integrated benefit-risk analysis
- ✓Reconciled with RMP and labelling
- ✓Two review cycles
We recommend commissioning at least one interval ahead, because the data lock point is fixed.
Deliverables Request a quoteStanding arrangement
Products with recurring reporting obligations
Quoted per projectBased on portfolio and reporting frequency
Delivery By schedule
- ✓Reports produced on the recurring cycle
- ✓Signals and commitments tracked across intervals
- ✓Continuity of authorship and terminology
- ✓RMP updates aligned to the reporting cycle
- ✓A standing schedule rather than a series of requests
Aggregate reporting is recurring and deadline-driven, so a standing arrangement is usually more efficient than individual requests.
Deliverables Request a quoteSend the last report in the series and the next data lock point, and we will prepare a schedule at no cost, including the critical path, which is usually the data extraction rather than the drafting.
FAQs
PSUR, PBRER and DSUR FAQs
If your question is not answered here, ask an expert. No quote is required.
Not exactly. ICH E2C(R2) introduced the periodic benefit-risk evaluation report, which replaced the older periodic safety update report format and is organised around evaluation rather than tabulation.
Many organisations still use the term PSUR informally, and some regional requirements still use it. A template that refers only to a PSUR may follow the older structure and is worth checking.
At least one interval ahead. The data lock point is fixed, and extraction, reconciliation, drafting and review must all fit between it and the submission date.
When the schedule is built back from the data lock point, the critical path is usually the data extraction rather than the writing.
It must evaluate the data. A section that restates the approved indication and concludes that the balance remains positive has not evaluated anything.
An effective evaluation compares the position at the end of the interval with the position at the start, states what changed and explains whether the conclusion still holds.
No. Case intake, coding, the safety database and signal detection as the accountable process sit with your pharmacovigilance function or provider.
We write the report from the data held in that system and reconcile the report against it. This separation of roles is deliberate.
Related Services
Related Pharmacovigilance and Regulatory Writing Services
Periodic safety reports are read alongside the risk management plan and the labelling.
1RELATED DOCUMENTSmust be consistent
Risk management planSafety specification and risk minimisation. Regulatory writingLabelling, dossiers and submissions.2SOURCE DATAsafety data and analysis
Patient narrativesDeaths, SAEs and discontinuations. BiostatisticsPooled safety analysis and exposure estimates.3SIGNAL EVALUATIONcharacterisation
Systematic reviewLiterature-based risk characterisation. Medical data collectionReal-world and registry data collection.Request a Free Reporting Schedule Based on Your Data Lock Point
We will prepare a schedule at no cost, including the critical path, which is usually the data extraction rather than the drafting.