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Confimedis Platform v3.13.0

Overview

Scope Feature
Version v3.13.0
Release date August 5, 2026
Deployed to Confimedis Cloud August 6, 2026
Affected modules General, Forms, Subjects

Validation

Validation by Confimedis

Confimedis GmbH has validated this release in accordance with its quality management system and GAMP 5 before deployment, re-executing the test cases of the Operational Qualification (OQ) for the affected functions according to their risk classification. A release does not change the configuration of your study, such as forms, edit checks, roles, or users, which your Performance Qualification (PQ) covers. Where existing settings are migrated, the note says so. The Validation Package of every release, including the OQ report and a prefilled Validation Summary Report (VSR), is available on request and only needed for an initial validation or a revalidation. A test project is a copy of your study without patient data, created via CDISC ODM export and import.

This release predates the introduction of Release Impact Statements. Its changes are listed below.

Changes

Features

  • General: Confimedis AI Assistant
    • The Confimedis Assistant (first released as a beta in v2.23.0) is now a generally available, conversational AI assistant with agentic and optional reasoning capabilities, available across the entire platform in the collaboration slideover.
    • It searches the help documentation to give concrete, grounded answers to questions about the application and its features.
    • It has access to the data in the study, including the form definitions and subject information. This allows it, for example, to find subjects with specific clinical values, compile tabular overviews, or identify forms that have not yet been verified, and then navigate directly to them in the application.
    • It can edit forms, extract clinical data (also from attached PDFs and images), and edit documents.
    • The assistant is triggered exclusively by a request and does not work in the background. Beyond that, the use of the assistant and its access to study data are protected by a five-level security system:
      1. Activation per project: The assistant can be fully deactivated for any project at any time.
      2. Data access per module: Its access to study data is disabled by default and must be enabled per module in the project settings.
      3. Use per role: Working with study data must then be enabled individually for each role through four new permissions (one for reading study data, three for editing forms, clinical data, and documents).
      4. Permission per user: The permissions of the respective user continue to apply unchanged, so the assistant only ever sees the data that user is allowed to see.
      5. Human control and responsibility: Every change requires explicit confirmation in a side-by-side comparison (human-in-the-loop) and is recorded in the audit trail.
    • Conversations with the assistant are iterative and interactive, so several questions can be asked in a row to refine a task, and multiple private conversations can be kept in parallel.
    • Instead of the Telekom Cloud, the assistant now builds on a Large Language Model (LLM) provided by Mistral AI from France under a Zero Data Retention agreement. All data is processed exclusively within the European Union and is neither stored nor logged nor used for training AI models.

Improvements

  • Forms: Pressing Cmd (macOS) or Ctrl (Windows) together with B (bold), I (italic), or U (underline) now toggles the corresponding Markdown formatting for the selected text in section and field labels.
  • Forms: When the choices of a field (i.e., its codelist) are also referenced by other fields, the choices panel now shows a hint with the number of references and allows detaching the choices as an independent copy, so that they can be edited without affecting the other fields.

Bug fixes

  • Subjects: Fixed an issue where conditionally hidden (i.e., disabled) fields in a data matrix were still validated, resulting in a mandatory field hint that prevented the form from being saved as complete.
  • Subjects: Fixed a rendering issue where the status icon of a form could still show the previous status after its data and status had been deleted.