Confimedis Platform v3.8.0
Overview
| Scope | Feature |
|---|---|
| Version | v3.8.0 |
| Release date | April 14, 2026 |
| Deployed to Confimedis Cloud | — |
| Affected modules | Notifications, Randomization, General |
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
- Notifications: Notification timings
- Automated email, SMS, and push notifications for scheduled events now support two new variants: Announcements (days before the time window starts) and Reminders (days before the time window ends).
- Besides study participants, these new notifications can now also be configured for team members, so they always know which participants have upcoming visits, even without opening the calendar.
- Additionally, for events without enabled ePRO links or authorized forms, study participants can still receive information-only reminders for non-remote, in-person visits.
- For multi-day events, an optional local time can be configured at which the notification is sent. If left empty, the notification is sent immediately as soon as the event falls within the current scheduling window (e.g., right after a participant self-registration).
In total, there are now 8 notification variants for scheduled events:
| Type | Study participants | Team members |
|---|---|---|
| Schedule reached (at time window start) | - With action (answer form) or - Information-only (without ePRO) | - With action (view subject) |
| Announcement (days / minutes before start) | - Information-only | - With action (view subject) |
| Reminder (days / minutes before end) | - With action (answer form) or - Information-only (without ePRO) | - With action (view subject) |
Improvements
- Randomization: Added a setting option to automatically randomize subjects upon creation or when required stratification variables become available.
Bug fixes
- General: Fixed an issue in Firefox where navigating the calendar could unexpectedly jump to a different year.