Confimedis Platform v3.9.0
Overview
| Scope | Feature |
|---|---|
| Version | v3.9.0 |
| Release date | April 23, 2026 |
| Deployed to Confimedis Cloud | April 23, 2026 |
| Affected modules | 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
- General: Confimedis Platform SDK
- The official TypeScript SDK for the Confimedis Platform is now available on npm.
- It allows you to integrate our platform into your web or mobile application, reporting pipeline, or any server-side automation or custom tooling built around your study.
- Fully typed end-to-end, it runs on any modern JavaScript runtime and gives you a clean, expressive API to work with all aspects of a clinical study:
- Data access: Query study metadata, clinical data, administrative data, and more, with flexible filtering, sorting, and cross-project support
- Data editing: Create or modify study data reliably with a single commit call, with all changes automatically recorded in the audit trail
- Audit trail: Query the complete history of all study data changes, supporting data integrity and GCP compliance
- Live updates: Subscribe to real-time changes via live queries that automatically reflect updates as they happen
- File management: Upload and download files securely with resumable transfers, supporting files up to 5 GB
