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Periodic Safety Report Writer

PBRERs and PSURs drafted section by section, every number linked to the query behind it

Every periodic safety report is fully drafted within two weeks of data lock, each number traced to its query.

Watch the filmBook a demo
See one case, screen by screen ↓
target13daysfrom the data lock point to a full draft of all 20 sections
target100%of numbers in the report linked to the query behind them
demo238numbersre-checked against the frozen data before the final signature — 0 differences
target4daysbefore the deadline on average, every report on time
The problem

Why a periodic report eats the whole 70-day clock

The clock starts at the data lock point. Seventy days later — ninety when the interval is longer than twelve months — the PBRER or PSUR is due, with 20 ICH E2C(R2) sections, exposure estimates, summary tabulations, signals and a benefit-risk conclusion, all reconciled with last year’s report.

Most of those days go on numbers, not judgement. Someone pulls the case listing, someone else rebuilds patient-years from a sales extract, the tabulations are pasted into Section 6, and then every reviewer asks the same question: where does this figure come from? Is the cumulative really prior plus interval? Does the infection count match the line listing? Each answer means re-running a query by hand — and a section cannot be signed until it is answered.

demo46daysmedian from data lock point to full draft, before agents
demo31%of review comments were questions about a number, before every number opened its own query
demo70daysfrom data lock point to submission — 90 when the interval is longer than 12 months
Where the days from data lock point to full draft goestimated
By hand46 days
With the solution13 days
  • Freezing the data and running the queries5 → 1 d
  • Exposure estimates and summary tabulations10 → 2 d
  • Drafting the status, findings and appendix sections18 → 6 d
  • Signals, risk evaluation and benefit-risk8 → 3 d
  • Cross-checking every number5 → 1 d

Estimated split for a typical annual PBRER, by hand and with the solution, in working days.

How it works

How a report moves

Five specialist agents pull the data, draft every section and check every number; section owners review and the QPPV signs.

What comes in
Data in4 sources · frozen at the data lock point
Agents at work
Data agentfreeze + run queries
Then
Section writerSections 1–4, 7–14, 20
Section writerSections 5–6 tables
Signal and risk writerSections 15–19
Then
Consistency checkerevery number re-run
A person decides
Section owners and QPPVreview, then sign
What comes out
Signed report
Every number traced
Filed on time
One case, step by step

One PBRER, from data lock point to QPPV signature

Monday, 3 August. The Veltrimab PBRER for 1 Jul 2025 – 30 Jun 2026 is due on 8 September, and Pravonix is due in six days. Here is the QPPV’s morning, screen by screen, in the working solution.

  1. 01Morning

    Every report that needs her, on one screen

    Dr. Maya Chen · QPPV

    Five reports in progress, nine sections and final reports waiting for her signature, six open review comments — each with an edit or reply already proposed — and 1,286 numbers in open reports, all traced to a query. The greeting says what matters: Pravonix is due in 6 days, and Veltrimab Section 5 is ready for her review.

    Agents at work: “Section writer — Drafted 11 Halvexa sections — 162 numbers, each linked to its query.”

  2. 02Opened

    The Veltrimab PBRER, section by section

    Dr. Maya Chen · QPPV

    Data lock point 30 Jun 2026, ICH E2C(R2), submitted in the EU as a PSUR under the EURD list. Fifteen of 20 sections are drafted and nine are signed. The activity trail shows how it got here: on 1 July the data agent froze 18,940 cases at the data lock point and ran 38 queries; the consistency checker then checked 214 numbers across sections and the prior report — 0 differences.

  3. 03One click

    “Draft 5 remaining sections”

    The agents

    Sections 14, 16, 17, 18 and 19 are still empty. The data agent re-runs 32 queries on the data frozen at 30 Jun 2026, the signal and risk writer drafts the sections from the query results, the prior report and the risk management plan, and the consistency checker checks every number against Sections 5 and 6 and the prior report. The drafts go to Dana Okafor, Dr. Maya Chen and Omar Haddad for review, and the report reaches 20 of 20 sections drafted.

    The benefit-risk conclusion is a proposal for the QPPV, never final.

  4. 04Section 5

    Click a number, see the query behind it

    Dr. Maya Chen · QPPV

    Section 5, Estimated exposure and use patterns, carries 18 numbers, all linked to a query. Maya clicks the cumulative exposure, 224,177 patient-years. The panel says it in plain words — pens shipped from 30 Dec 2021 to 30 Jun 2026, returns removed, divided by 13 pens per patient-year — then shows the query, the result by region and the checks it passed.

    “Sum of 4 regions = 224,177” · “Matches the source” · Sales and exposure extract, 6 Jul 2026.

  5. 05Review comments

    A reviewer’s question, already answered

    Sam Patel · Epidemiology

    Sam, who reviews the exposure section, asked: “Japan also sells the 75 mg pen for patients under 60 kg. Are those counted as half a dose?” The review assistant checked the query: it already counts two 75 mg pens as one 150 mg dose, so no number changes. It proposes one sentence for the method in 5.2 instead.

    Proposals only — a person accepts or rejects every one.

  6. 06Accepted

    The edit lands, and the reconciliation is shown

    Dr. Maya Chen · QPPV

    Maya accepts the edit; the sentence appears in 5.2, highlighted, and Sam is notified. Lena Ortiz from regulatory affairs had asked for the cumulative exposure to reconcile with last year’s report. The answer is on the comment, with its source: 133,054 patient-years in the PBRER for DLP 30 Jun 2025 (Section 5.2, Table 5.3) plus 91,123 in this interval equals 224,177. Maya resolves it.

  7. 07Signed

    Every query re-run before her signature

    Dr. Maya Chen · QPPV

    With no comments open, Maya signs the section. Before the signature goes through, the 18 queries are re-run on the frozen data — every number matches the draft — and the cumulative is checked against prior plus interval. Her name, the date and time and the meaning “I approve this section for the final report” are recorded, linked to this version. The history shows each step, and 10 of 20 sections are now signed.

    “Section 5 signed by Dr. Maya Chen · 10 of 20 sections signed”

  8. 08Check numbers

    One difference, found before anyone signs it

    Consistency checker

    Maya runs the full check: every query re-run on the frozen data (214 numbers), every total and sub-total, cumulative equals prior plus interval, the same figure the same in every section. One difference: Section 11 says 1,912 literature records were screened, but the literature log returned 1,914 after its refresh on 31 Jul 2026, when two records wrongly marked as duplicates were restored. The fix waits for her: “Use 1,914”.

    The checker never changes a draft without approval — every finding shows both values.

  9. 09Due in 6 days

    Pravonix, ready for the final signature

    Dr. Maya Chen · QPPV

    The Pravonix PBRER has all 20 sections signed. The consistency checker re-checked 238 numbers against the frozen data before the final signature — 0 differences — and the submission package is built. Maya signs the final report with the meaning “I approve this report for submission as QPPV”, and it goes to regulatory operations for submission.

  10. 10Last 12 months

    Every periodic report, on time

    Dr. Maya Chen · QPPV

    Thirteen of 13 reports submitted on time, on average 4 days before the deadline. A median of 13 days from data lock point to full draft — it was 46 before the agents. Every one of 8,214 numbers since go-live traced to a query, and 91% of 604 review comments closed within two days. Number questions fell from 31% to 22% of comments once every number opened its own query.

Who it’s for

Built for everyone who signs off a periodic report.

The same PBRER, seen by the five people who carry it — what their cycle looked like, and what it looks like now.

MC
Dr. Maya ChenQPPV · EU and UK
QPPV
Before
Signs sections whose figures she cannot trace without asking someone to re-run the numbers.
Now
Clicks any number to see its query; every query is re-run on the frozen data at her signature.
SP
Sam PatelEpidemiology — exposure and summary tabulations
Section owner
Before
Rebuilds patient-years from the sales extract every cycle and reconciles them with last year’s report by hand.
Now
Reviews Section 5 with every figure linked to its query; his questions come back with an edit already proposed.
LO
Lena OrtizRegulatory affairs — approval status, actions and reference safety information
Section owner
Before
Waits days for an answer to “does this reconcile with the prior report?”
Now
Gets the reconciliation on the comment, with the page and table of last year’s report it rests on.
OH
Omar HaddadClinical safety physician — clinical findings
Section owner
Before
Starts the clinical and benefit sections from a blank template and last year’s text.
Now
Reviews drafts written from the query results and the risk management plan, with anything that needs medical judgement marked for him.
DO
Dana OkaforSafety writer
Safety writer
Before
Finds out a source is missing when a section is already half written.
Now
Sees the data pull at the data lock point, source by source; drafting waits until every source is in.
Built on the engine

5 agents. Each with one job, and hard limits.

Five specialist agents pull the data, draft every section and check every number; section owners review and the QPPV signs.

Data agent

Freezes the case database at the data lock point and runs the saved queries for exposure, tabulations and signals — every result stored with its query, the data extract, the run time and the row count.

  • Read-only access to source systems
  • Every number is stored with its query
  • Stops when a source is missing and tells the report owner
Section writer

Drafts each ICH E2C(R2) section in house style from the query results, the prior report and the reference safety information, carrying forward text only where the facts are unchanged.

  • No number without a linked query
  • No medical conclusions without a person
  • Plain, factual wording
Signal and risk writer

Drafts the signal and risk sections from the signal tracker, the risk management plan and the case series for each signal — every signal open, ongoing or closed in the interval, with dates, sources and outcomes.

  • Conclusions are proposals for the QPPV
  • Reporting rates use the exposure in Section 5
Consistency checker

Re-runs every number’s query on the frozen data and checks totals, sub-totals, cumulative = prior cumulative + interval, and that the same figure is the same in every section.

  • Never changes a draft without approval
  • Every finding shows both values
Review assistant

Reads each reviewer comment, re-checks the numbers and passages involved, and proposes an edit (as a tracked insertion) or a reply with the evidence for the section owner to accept.

  • Proposals only — a person accepts
  • Cites the evidence for every reply
Section owners and QPPV

Review, then sign. The agents propose; a named person decides.

Ask in plain words

Ask about any report, number or deadline

Everyone on the report can ask in plain words — or tell it what to change. Every answer points to its source.

What is left before Veltrimab can be submitted?

Due 8 Sep 2026 (36 days). 15 of 20 sections drafted, 9 signed. Not drafted: 14, 16, 17, 18, 19. In review: 5, 6, 11, 15. Drafted, not reviewed: 13, 20. Section 16 waits for the eczematous reactions assessment due Aug 7; Sections 17–19 follow from it. At the current pace the report is ready to sign around Aug 24 — 15 days before the deadline.

Where does 224,177 patient-years come from?

It is the cumulative post-marketing exposure in Section 5.2: pens shipped from 30 Dec 2021 to 30 Jun 2026, returns removed, divided by 13 pens per patient-year. Previous report (DLP 30 Jun 2025): 133,054; this interval: 91,123; cumulative: 224,177.

Flag interval counts that changed more than 25% from the prior report

Done — the rule “Flag large changes from the prior report” is on. In Veltrimab Section 6.3 two organ classes are marked: infections 352 → 468 (+33%) and skin 151 → 214 (+42%). Exposure rose 23% in the same interval, so the infection rate per patient-year is close to last year’s; the skin increase is mostly the eczematous reactions signal.

Are there any inconsistent numbers?

One: Section 11 of the Veltrimab report says 1,912 literature records were screened; the literature log says 1,914 after the 31 Jul refresh. Use Check numbers in the report to accept the fix.

Every screen

The working solution, as it ships.

13 screens from the working solution, on its sample data. Pick one to see it large.

HomeWhat needs the QPPV today: reports in progress, sections waiting for signature, open comments, the coming data lock points and what the agents did overnight.
The report overviewOne PBRER section by section: drafted, signed and in review, what waits for whom, and the activity trail from the data lock point on.
Agents draftingQueries re-run on the frozen data, the remaining sections drafted, every number checked, and the drafts assigned for review.
Number to queryClick 224,177 patient-years to see it in plain words, the query, the result by region and the checks it passed.
Review commentsEach reviewer comment with an edit or a reply proposed by the review assistant, ready to accept or resolve.
Edit acceptedThe accepted sentence lands in Section 5.2, highlighted, and the reviewer is notified.
Section signedSection 5 signed by the QPPV after its queries were re-run on the frozen data; the history shows each comment resolved and the signature.
Consistency checkEvery query re-run, totals added up, cumulative checked against prior plus interval — and one difference found, with the fix waiting for approval.
Ready for the final signatureAll 20 sections signed, 238 numbers re-checked with 0 differences, the submission package built.
Data pull at the data lock pointSource by source at the data lock point; when the signal tracker export is missing, drafting waits rather than writing from partial data.
Data sources and the query libraryWhat the data agent reads at each data lock point, and every saved query with the section it feeds, its last run and its owner.
The dashboardOn-time submission, days from data lock point to full draft, numbers traced, what reviewers commented on and where the numbers came from.
Your rulesWho signs and reviews each group of sections, what blocks a signature, the coding dictionary, the exposure method and reminders.
Governance

Built for pharmacovigilance: traced, re-checked, signed.

Every number links to a queryA number without a saved query cannot enter a draft. Click any figure to see the query text, the data extract it ran on, the result and the checks it passed.
Data frozen at the data lock pointThe agents read a frozen copy of the case database and the other sources, with read-only access. Re-running a query always gives the same answer.
Re-checked at every signatureWhen a section is signed, its queries are re-run on the frozen data and cumulative figures are checked against prior plus interval; the signature is blocked if a number changed.
Agents propose, people decideEdits arrive as tracked proposals and fixes wait for approval. Conclusions on signals and benefit-risk are proposals for the QPPV, never final.
The QPPV signs every sectionA section can be signed only when every reviewer comment is resolved. The signature records the name, date and time, and its meaning, linked to that version of the section.
Every step on the recordEach agent run and each human decision is in the report’s activity trail and the section’s history, with who, what and when. Auditors can read reports, queries and the trail.
Configuration

Your safety team’s rules, not ours

Who signs, what blocks a signature and how exposure is estimated are settings, applied to every open report.

SettingDefaultChoose from
Signs every section and the final reportDr. Maya Chen (QPPV)Dr. Maya Chen · Omar Haddad
Block signing while comments are openOnOn · Off
Re-run the queries when a section is signedOnOn · Off
Flag large changes from the prior report (interval counts that changed more than 25%)OffOn · Off
Coding dictionary for the summary tabulationsMedDRA 29.0 (March 2026)MedDRA 29.0 (March 2026) · MedDRA 28.1 (September 2025)
Post-marketing exposure methodUnits shipped ÷ units per yearUnits shipped ÷ units per year · Defined daily doses
Freeze the case database at23:59 UTC23:59 UTC · 23:59 local time of the safety database
Reminders before the submission date30, 14 and 7 days30, 14 and 7 days · 21, 7 and 2 days
Connections

Works with the safety systems you already run

Case databasea frozen copy at each data lock point
Sales and exposure dataunits shipped by region and month
Signal trackersignals with status, dates and outcomes
Clinical trial databasesubject exposure and adverse events
Literature search logweekly searches and screening decisions
Prior reports and safety documentssigned reports, CCDS and risk management plans
What it changes

The difference, in numbers.

Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.

target
13days
from data lock to a full draft
By hand46 days
With agents≈ 13 days
target
100%
of numbers linked to the query behind them
every query re-run before signature
target
4days
before the deadline on average, every report on time
13 of 13 on time
reports in the last 12 months

“demo” = seen in the working solution, on its sample report data · “target” = the design goal, measured in the live solution (median days from data lock point to full draft, on-time submissions) · “estimated” = our estimate · Sources: ICH E2C(R2) periodic benefit-risk evaluation report. People, companies and products named on this page are fictional — characters and sample data in the working solution.

Questions

What safety teams ask us.

What is a periodic safety report writer?

Software that takes a PBRER or PSUR from the data lock point to a signed report. Periodic Safety Reports freezes the data, drafts all 20 ICH E2C(R2) sections in your house style, links every number to the query behind it and routes each section to its owner for review and to the QPPV for signature.

How does it make sure the numbers are right?

Every number is stored with its query, the data extract and the run time, and a number without a saved query cannot enter a draft. The consistency checker re-runs each query on the frozen data, checks totals and sub-totals, checks that cumulative equals prior cumulative plus interval, and that the same figure is the same in every section. The queries are run again when a section is signed.

Does it handle both PBRERs and PSURs?

Yes. The working solution runs six-monthly, annual and three-yearly PBRERs and EU PSURs under the EURD list, each with its own interval, data lock point and submission date — 70 days after the data lock point, or 90 when the interval is longer than 12 months.

Does the AI change our safety database?

No. The data agent has read-only access and works from a frozen copy taken at the data lock point, so re-running a query always gives the same answer. If a source is missing, it stops and tells the report owner, and drafting waits until every source is in.

Can the agents write the signal and benefit-risk conclusions?

They draft them, as proposals. The signal and risk writer summarises the case series, reporting rate and evidence for each signal, and its conclusion is proposed for the QPPV, never final. Anything that needs medical judgement is marked for the section owner.

Do people stay in control?

Yes. Section owners review and comment, the review assistant only proposes edits and replies, and a person accepts or rejects every one. A section can be signed only when its comments are resolved, and the QPPV signs every section and the final report with the meaning of the signature recorded.

Which systems does it read?

Your case database, sales and exposure data, the signal tracker, the clinical trial database, the literature search log, and your prior reports, Company Core Data Sheets and risk management plans. The draft exports to Word in your house template, with a number-to-query trace as an appendix.

How long does it take to go live?

The Agentic Solution Engine builds and deploys it from your requirements and documents — your house template, your saved queries and a prior report — and it goes live once every quality gate has passed.

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See it on
your next PBRER.

We’ll run Periodic Safety Reports on your prior report and a frozen copy of your own data.

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