A Lorgani™ application Current

Intelligent Dossiers

Transform heterogeneous source evidence into structured, traceable and reviewer-ready aggregate safety reports and regulatory dossiers.

DSUR PBRER PADER

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What it produces

  • Regulatory & safety dossiers
  • DSUR · PBRER · PADER

Structured, traceable, reviewer-ready regulatory and safety dossiers.

iDossi in action

From heterogeneous evidence to a reviewer-ready dossier.

Different kinds of source evidence come together, platform intelligence organizes and connects them, qualified people review and approve - and a structured dossier results.

Source evidence

  • Previous DSUR
  • Investigator’s Brochure / RSI
  • Trial listings
  • Exposure information
  • SAE / SUSAR information
  • Clinical summaries
  • Literature
  • Regulatory information

Lorgani intelligence

  • Liorta Protection Engine
  • Contextual Intelligence
  • Evidence Intelligence
  • Content Intelligence
  • Validation Intelligence
  • Workflow Intelligence

Human review & approval

  • Keeps appropriate expert review and accountability with people.

Structured dossier

  • DSUR
  • PBRER
  • PADER

The challenge

Why aggregate safety reports are hard

Each report is due on a fixed regulatory timetable, draws on evidence spread across safety databases (adverse events and adverse drug reactions), clinical and exposure data, literature and prior reports, and must be consistent with everything submitted before. Much of the effort goes into assembling and reconciling - time experienced reviewers would rather spend on assessment.

Why a general AI assistant is not enough for a DSUR or PBRER

  • The evidence is defined by the reporting period Each report draws on a controlled set of sources for a specific interval - safety data, exposure, literature and reference safety information - not on whatever a model happens to know.
  • The structure is set by regulation Sections follow ICH E2F for the DSUR and ICH E2C(R2) for the PBRER, and must stay consistent with the reports submitted before.
  • Every statement must hold up at inspection Content has to trace back to its source and be reviewed and approved by qualified professionals before it is submitted.

Document types

DSUR

Development Safety Update Report

An annual, comprehensive review of safety information for investigational products under development, following the structure of ICH E2F.

PBRER

Periodic Benefit-Risk Evaluation Report

A periodic evaluation of the benefit-risk balance of a marketed product, following the structure of ICH E2C(R2); in the EU it is submitted as the Periodic Safety Update Report (PSUR).

PADER

Periodic Adverse Drug Experience Report

Periodic postmarketing safety reporting for products marketed in the United States.

What iDossi helps you do

From source evidence to an approved report - with people in control.

  1. Source evidence, organized

    Heterogeneous inputs for the reporting period - prior reports, reference safety information, listings, exposure data, literature and regulatory information - are brought together and organized around the report.

  2. Mapped to the report structure

    Evidence is associated with the sections of the standard report structure it supports, so every section starts from the right material.

  3. Content prepared for review

    Section content is prepared in the expected structure and style as a starting point for expert assessment - not a finished conclusion.

  4. Traceable to source

    Content stays connected to the evidence behind it, supporting review, quality checks and inspection readiness.

  5. Controlled regeneration

    When evidence or reviewer direction changes, specific sections can be prepared again under control rather than rewriting the report.

  6. Versioned

    Drafts, revisions and decisions are versioned so the history of the report is clear.

  7. Reviewed and approved by people

    Qualified reviewers assess, edit and approve; nothing is final without human approval.

Who it serves

Built for the teams who own the work

  • Pharmacovigilance (PV) and drug safety teams
  • Regulatory affairs
  • Safety physicians and medical reviewers
  • Medical writing
  • CROs delivering safety reporting for sponsors

Outcomes

What changes

  • Supports preparation of reviewer-ready reports against fixed regulatory timelines
  • More reviewer time spent on assessment, less on assembly
  • Consistency with prior reports and related documents
  • Clear evidence trails for review and inspection

People stay accountable

Keeps appropriate expert review and accountability with people. The Liorta Protection Engine is designed into the work to help safeguard designated sensitive and confidential information.

Built on Lorgani

iDossi is one application of one intelligent foundation.

Different applications. Different outcomes. One Lorgani platform.

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See iDossi in action.

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